Clinical trials from Sanity

Phase IIb randomised, double-blind trial (n=96) comparing two doses of psilocybin (25 mg vs 5 mg) plus psychological support; two doses given one month apart with outcomes over 33 weeks in adults with severe GAD.

Open-label, single-group Phase II pilot (n=38) testing two IV ketamine infusions (0.5 mg/kg each, 40 min, at H0 and H24) plus Good Psychiatric Management in adults with severe BPD; primary outcome at day 9 (BSL-23).

Phase II, assessor-blinded, randomised controlled trial (n=30) of a single 25 mg oral synthetic psilocybin dose given with either standard psychological support or psychological support plus MBCT in adults with PTSD.

This Phase I, open-label, dose-escalation trial (n=10) will evaluate the safety and psychological effects of a combined psilocybin and D-Serine formulation; cohort 1 will receive psilocybin 15 mg with D-Serine 5 g, and if safe cohort 2 will receive psilocybin 25 mg with D-Serine 7 g.

Open-label, randomised, parallel pilot RCT (n=30) comparing ketamine (0.5 mg/kg IV x4 over 2 weeks) plus MBCT versus MBCT alone for adults with comorbid chronic pain and PTSD.

This Phase I, open-label trial (n=30) will study the psychological and biological effects of MDMA-assisted therapy in mental health providers in training, with a single experimental MDMA session (120 mg initial oral dose with optional 40 mg supplemental dose 1.5–2 hours later), plus preparatory and integration sessions.

Phase I open-label single-cohort IV study (n=4) assessing safety and PK of a single TRP-8803 (psilocin besylate) infusion (5 mg loading over 20 min then 5 mg over 120 min) with psychedelic-assisted psychotherapy in healthy adults.

Open-label, randomised Phase I trial (n=20) assessing safety and tolerability of single 25 mg or split 12.5 mg+12.5 mg oral psilocybin in people with chronic stroke; secondary outcomes explore motor recovery.

This double-blind, placebo-controlled, crossover trial (n=48) will study the effects of psilocybin (15 mg) on memory, cognition, and brain function in healthy adults.

This open-label, randomised controlled Phase II trial (n=30) will test a six-week Fly-In-Fly-Out Psilocybin-Assisted Therapy (FIFO-PAT) programme for major depressive disorder (MDD), using a single 25 mg oral dose of psilocybin alongside psychotherapy and either a virtual-reality (VR) integration tool or journaling.

This randomised, quadruple-blind, placebo-controlled Phase II trial (n=50) will assess the effects of ketamine (52.5mg/70kg; 0.75 mg/kg IM, four doses over two weeks) on opioid craving and withdrawal symptoms in adults newly entering methadone treatment for opioid use disorder.

This quadruple-blind, randomised controlled trial (n=76) will study the effects of psilocybin (25mg or 1mg) combined with Acceptance and Commitment Therapy (ACT) in adult survivors of intimate partner violence (IPV) with post-traumatic stress disorder (PTSD).

Phase II, single-group, open-label study (n=35) of a single 25 mg oral psilocybin dose with psychotherapy for cisgender women with PTSD secondary to sexual assault.

This open-label Phase I trial (n=15) will assess the feasibility and safety of a single 25 mg dose of pharmaceutical-grade psilocybin combined with psychotherapy in women aged 18–45 with chronic pelvic pain (CPP) who have not responded to at least one conventional treatment.

This randomised, double-masked Phase I/II trial (n=20) will study the safety, tolerability, and efficacy of psilocybin (10mg vs 30mg) across four sessions for the treatment of obsessive-compulsive disorder (OCD).

Phase III, randomized, quadruple-blind, placebo-controlled parallel-arm RCT (n=120) testing psilocybin microdosing (2–3 mg, 4 days/week for 2 weeks) versus placebo to reduce psychological and existential distress in patients receiving palliative care.

This open-label Phase I/II trial (n=12) will study the effects of oral ketamine (beginning at 35 mg/70 kg and increasing to 140 mg/70 kg) in combination with prolonged exposure therapy for the treatment of post-traumatic stress disorder (PTSD).

This randomised, double-blind, low-dose comparator-controlled Phase IIb trial (n=87) will study the effects of different doses of psilocybin (PEX010; 1-10-25mg) delivered during a psilocybin-assisted psychotherapy (PAP) session in individuals with adjustment disorder following a cancer diagnosis.

Phase III double-blind, randomised, placebo-controlled trial (n=30) testing IV ketamine 0.5 mg/kg given during ECT sessions 2, 4 and 6 in hospitalised adults with treatment-resistant MDD.

Phase III, quadruple-blind, randomised, placebo-controlled trial (n=330) of CYB003 (8 mg and 16 mg; two dosing sessions ~3 weeks apart) as adjunctive treatment for major depressive disorder.

This Phase II open-label trial (n=15) will study the effects of psilocybin (25 mg) administered in the context of Psilocybin-assisted Existential, Attachment and Relational (PEARL) therapy for caregivers of patients with advanced cancer.

This Phase I randomised, single-blind trial (n=20) will study the effects of multiple low doses of psilocybin (MLS101) on brain activity, safety, tolerability, and pharmacokinetics in healthy adult volunteers.

This open-label fixed-dose trial (n=10) aims to determine the safety and feasibility of MDMA-assisted psychotherapy (80-120mg) for adolescents with treatment-resistant post-traumatic stress disorder (PTSD).

Early Phase I, randomised, placebo-controlled single-session study (n=48) testing a low (13 µg) dose of LSD versus placebo under known versus uncertain drug-identity instructions (balanced placebo design).

This open-label Phase II trial (n=30) will investigate the feasibility, safety, and antidepressant effects of oral ketamine (starting at 1 mg/kg, up to 2 mg/kg) in adults with bipolar depression.

This randomised, double-blind, placebo-controlled Phase IV trial (n=50) will study the effects of a single low-dose intravenous esketamine (0.2 mg/kg; ~14 mg/70 kg over 40 minutes) combined with oral duloxetine (60 mg/day) on depression in patients with postherpetic neuralgia.

This randomised, double-blind, placebo-controlled Phase II trial (n=60) will study the feasibility, safety, and acceptability of oral ketamine (60–180 mg, administered twice weekly) as a treatment for adults with long-standing anorexia nervosa and comorbid treatment-resistant depression.

This open-label, single-arm Phase IV trial (n=47) will evaluate the efficacy and safety of esketamine nasal spray (flexibly dosed at 56mg or 84mg) in Korean adults with treatment-resistant depression (TRD).

This Phase I open-label trial (n=12) will investigate the safety, feasibility, and initial efficacy of intravenous psilocin (TRP-8803), administered in two doses (ranging from 6.7 mg to 15 mg) two weeks apart, paired with psychedelic-assisted psychotherapy for adults with binge eating disorder (BED).

This Phase II randomised, quadruple-blind, placebo-controlled trial (n=200) will assess the safety and efficacy of intranasal SLS-002 (ketamine, 78mg) for post-traumatic stress disorder (PTSD) in active-duty service members and veterans.

This open-label, randomised crossover trial (n=25) will investigate the effects of intravenous (IV) ketamine (35 mg/70 kg; 0.5 mg/kg over 1 hour) combined with self-selected music, therapist-selected music, or silence on chronic noncancer pain.

This Phase I, double-blind, active-controlled trial (n=40) will investigate the safety and potential therapeutic effects of co-administered MDMA and psilocybin in military Veterans diagnosed with post-traumatic stress disorder (PTSD).

This open-label Phase II trial (n=100) will study the safety, tolerability, and potential therapeutic effects of psilocybin (2 x 25 mg oral doses, taken at least 3 weeks apart) in the biological children of genocide survivors who are living with mood and anxiety disorders.

This randomised, quadruple-blind, placebo-controlled Phase III trial (n=90) will study the effectiveness, safety, and tolerability of psilocybin (25 mg)–assisted therapy compared to an active placebo (1 mg psilocybin) in individuals with treatment-resistant depression associated with bipolar II disorder.

This open-label, Phase II trial (n=20) will investigate the feasibility, safety, and effects of psilocybin-assisted psychotherapy for cancer survivors experiencing depression and/or anxiety.

This Phase IIa, placebo-controlled, double-blind trial (n=50) will study the safety, tolerability, and preliminary efficacy of a 3 mg dose of psilocybin (oral solution) in adults with generalised anxiety disorder (GAD).

This interventional single-group feasibility study (n=20) will assess 8 weekly ACT sessions combined with clinic IV ketamine infusions for adults (18–70) with alcohol use disorder and treatment-resistant depression.

This randomised, triple-blind, placebo-controlled Phase I crossover trial (n=24) will compare the acute effects of two enantiomers of MDMA—R-MDMA (300 mg) and S-MDMA (100 mg)—in healthy adult participants.

This randomised, double-blind, placebo-controlled Phase III trial (n=60) will investigate the efficacy and safety of subcutaneous ketamine (35-70mg/70kg, twice weekly for four weeks) as an add-on treatment for adolescents experiencing a major depressive episode with suicidal ideation and/or behaviour.

Open-label Phase II pilot (n=20) testing feasibility, safety and preliminary efficacy of high-intensity inpatient MDMA-assisted psychotherapy for treatment-refractory PTSD; two MDMA sessions (80+40 mg; 120+60 mg) integrated into a four-week inpatient programme with manualised preparatory and integrative therapy.

This Phase II, randomised, placebo-controlled, double-blind, parallel-group single-centre trial (n=75) will assess the effects of a single IV ketamine infusion (0.8 mg/kg) combined with real-time fMRI neurofeedback versus sham NFT and placebo in people with alcohol use disorder.

Open-label, single-arm Phase I pilot (n=20) assessing a single 10 mg oral dose of psilocybin in adults with chronic pain who have implanted sensing-capable DBS devices; neural, sensory, and cognitive effects measured.

This randomised, double-blind, placebo-controlled Phase III trial (n=140) will evaluate the efficacy and safety of a single oral dose of MM120 (100 µg LSD D-tartrate) for the treatment of major depressive disorder (MDD).

This open-label, Phase II/III trial (n=36) will study the effects of ketamine (0.5 mg/kg IV infused over 40 minutes, four infusions over two weeks) on suicidal ideation in individuals with major depressive disorder (MDD).

Double-blind, placebo-controlled, 4-period crossover study (n=24) testing 20 mg psilocybin and 100 mg MDMA alone and combined in healthy adults to assess subjective and autonomic effects.

This randomised, placebo-controlled, quadruple-masked trial (n=112) will investigate whether the antidepressant effects of DMT (2 mg/min over 20 minutes; total ~40 mg) in patients with MDD depend on the subjective psychedelic experience by comparing DMT vs placebo under propofol sedation or no sedation.

This randomised, placebo-controlled, triple-blind Phase I crossover trial (n=24) will compare the acute and subacute effects of LSD (150µg), psilocybin (30mg), and DMT (up to 2 mg/min intravenous infusion) in healthy adults, with all sessions standardised using ketanserin (20 mg IV) to end the psychedelic experience after three hours.

This double-blind, randomised, placebo-controlled trial (n=40) will investigate the persisting effects of a single dose of psilocybin (1-30mg) on structural plasticity in healthy older adults.

Open-label single-group study (n=10) assessing feasibility, safety, and preliminary efficacy of a single 25 mg oral psilocybin dose with preparatory and integration therapy for UCSD physicians with burnout.

This open-label, early Phase I trial (n=10) will investigate the effects of a single intravenous ketamine infusion (0.5 mg/kg over 40 minutes) on glutamatergic activity and synaptic strength in individuals with treatment-resistant major depressive disorder (MDD).

Phase II, single-group supportive-care study (n=20) of low-dose oral psilocybin (source: Psilocybe mexicana) given twice weekly for 4 weeks (8 doses) with preparatory and integration psychotherapy in cancer patients with chronic opioid-treated pain.

This randomised, triple-blind, placebo-controlled Phase II mechanistic trial (n=40) will assess a single 16 mg oral dose of CYB003 versus placebo on brain activity and connectivity in participants with MDD and moderate-to-severe anxiety.

Randomised controlled feasibility trial (n=40) comparing a 21-day meditation-based DIPP versus a music-based DIPP control, each followed by a supervised 25 mg psilocybin session at University College London.

This Phase IIa, multi-centre, double-blind, randomised, placebo-controlled trial (n=60) will investigate the safety, tolerability, and efficacy of EMP-01 in adults with social anxiety disorder (SAD). Participants will be randomised 1:1 to receive two administrations of either 225 mg EMP-01 or placebo on Day 1 and Day 29, with the primary endpoint assessed at Day 43.

Randomized Phase III pilot trial (n=31) comparing standard IV ketamine (0.5 mg/kg over 45 minutes, 4 sessions) versus ketamine with concurrent immersive VR in adults with treatment-resistant depression.

Randomised, triple-blind, placebo-controlled, parallel-group Phase II trial (n=30) comparing single IV ketamine 0.5 mg/kg versus saline infusion in adults with treatment-resistant depression; primary outcomes include central and peripheral GABA and glutamate changes and change in MADRS at 24 hours.

This open-label Phase I trial (n=15) will investigate the effects of psilocybin (25mg) on brain function and cognitive control in healthy adults, using electroencephalogram (EEG) and transcranial magnetic stimulation (TMS).

Open-label, single-arm early Phase I pilot (n=20) assessing feasibility and tolerability of a single 25 mg oral psilocybin dose to promote abstinence in adults receiving residential treatment for methamphetamine dependence.

Double-blind, adaptive, two-stage, multi-site, Phase II randomised trial (up to 480 consented to yield 240 randomized) comparing single moderate (20 mg) and high (30 mg) doses of oral psilocybin with low-dose (1 mg) control in OUD patients on methadone.

Randomised, quadruple-masked Phase II trial (n=24) comparing single low (1 mg) vs high (25 mg) PEX010 psilocybin doses to study motivation/reward and cognitive flexibility circuits in people with opioid use disorder.

Quadruple-blind, randomised, low-dose controlled Phase II trial (n=108) comparing two escalating psilocybin doses (15 mg then 25 mg) versus two low doses (1 mg) in palliative patients with COPD, ALS, MS, or APD and co-morbid depression.

This Phase II, double-blind, placebo-controlled trial (n=40) will investigate the safety, effectiveness, and lasting effects of psilocybin (25mg) combined with psychological support (Psi-PS) in military veterans and first responders with both alcohol use disorder (AUD) and post-traumatic stress disorder (PTSD).

This triple-blind, placebo-controlled trial (n=30) will investigate the effects of a sub-hallucinogenic dose of psilocybin (5 mg) combined with Imagery Re-Scripting (ImRS) on cognitive processes and self-harm behaviour in young people aged 16–25.

This open-label, Phase I trial (n=15) will assess the safety and efficacy of psilocybin (25mg) alongside psychotherapy for treating demoralization syndrome in patients with advanced-stage cancer.

This Phase I, randomised, placebo-controlled, triple-masked, crossover design trial (n=60) will investigate the safety, tolerability, electrophysiological effects, and efficacy of dimethyltryptamine (DMT) in individuals with major depressive disorder (MDD) and healthy controls.

Non-randomised, parallel interventional study (n=40) testing sequences of HRT, MeRT, ibogaine and 5‑MeO‑DMT in Special Operations Forces veterans with PTSD and cognitive difficulties following TBI.

This open-label trial (n=24) will assess the feasibility of psilocybin therapy in patients with Amyotrophic Lateral Sclerosis (ALS) experiencing depressed mood. Participants will undergo an 8-week treatment course, including two psilocybin sessions (15 mg in week 4 and 15 or 25 mg in week 6), with follow-up assessments at 1, 3, and 6 months post-treatment.

This open-label, Phase III long-term extension trial (n=468 estimated) assesses the safety and long-term efficacy of CYB003 in participants with MDD; participants may receive up to three 16 mg CYB003 medicine sessions ~3 weeks apart while continuing stable antidepressant therapy.

This open-label, proof-of-concept trial (n=8) will investigate the feasibility and effects of combining intranasal esketamine (28-84mg) with Prolonged Exposure (PE) therapy for the treatment of post-traumatic stress disorder (PTSD). Participants will receive 10 sessions of PE in a massed format over two weeks, alongside esketamine administered six times (three times per week) approximately one hour after specific PE sessions.

This randomised, double-blind, placebo-controlled trial (n=175) will investigate the efficacy of stellate ganglion block (SGB) and ketamine infusion, both separately and in combination, in treating PTSD and TBI-associated headache.

Open-label, interventional single-group study (n=100) delivering six IV ketamine infusions over two weeks (induction; 0.2–0.5 mg/kg initial titrated to 1.0 mg/kg; ~40 min per infusion) followed by up to six maintenance infusions every 3–6 weeks for Australian veterans with TRD and PTSD.

This open-label, Phase II trial (n=20) will study the effects of a single intravenous (IV) dose of ketamine (35mg/70kg; 0.5 mg/kg over 40 minutes) on cognitive flexibility in adolescents and young adults (ages 16–26) medically hospitalised for anorexia nervosa or atypical anorexia nervosa.

Phase I interventional study (n=50) comparing ketamine pharmacokinetics and pharmacodynamics in postpartum cesarean patients versus healthy controls using a 12-hour infusion (0.18 mg/kg/hr x1 h loading then 0.05 mg/kg/hr x11 h maintenance).

Triple-blind, placebo-controlled, within-subjects study (n=50) testing whether various psychoactive substances (psilocybin, ketamine, DXM, DMT, MDMA, THC) produce experiences similar to classic psychedelics across up to six single-dose sessions.

This observational cohort study (n=200) will assess whether a speech-based machine learning algorithm can predict treatment response to psychiatric interventions, specifically repetitive transcranial magnetic stimulation (TMS) and Spravato (esketamine) nasal spray.

Double-blind, placebo-controlled randomised trial (n=1670) testing low-dose intraoperative and postoperative esketamine versus placebo to prevent postoperative delirium in high-risk elderly patients undergoing major non-cardiac surgery.

This open-label trial (n=30) will study the feasibility of administering a single dose of psilocybin (25mg) to adults with mild to moderate depression or anxiety who have shown limited improvement with brief psychological intervention.

This interventional trial (n=141) will investigate whether transcutaneous auricular VNS (taVNS) after a single 25 mg psilocybin dose enhances antidepressant effects in adults with major depressive episodes.

This open-label trial (n=10) will investigate the effects of a single dose of MDMA on social cognition in adults with Borderline Personality Disorder (BPD).

Open-label, single-arm early-phase I study (n=12) testing a single 25 mg oral dose of psilocybin for individuals with prolonged grief disorder to assess feasibility and symptom change.

Randomised, quadruple-blind, placebo-controlled parallel trial (n=60) testing whether 5-HT2A blockade with pimavanserin (34 mg) alters the subjective and antidepressant effects of a single 25 mg oral dose of psilocybin in people with MDD.

This interventional, randomised, double-blind, triple-masked crossover study (n=16) will assess dose-response and the role of 5-HT2A receptors on psilocybin effects using single oral doses (5, 10, 20, 40 mg), a 40 mg ketanserin pretreatment condition, and placebo.

This quadruple-blind, placebo-controlled trial (n=36) will investigate the role of stress response in shaping the positive effects of psilocybin (25mg or 1mg) by using metyrapone (750mg) to suppress cortisol production.

This triple-blind, randomised, placebo-controlled trial (n=60) will study the role of neuroplasticity in the behavioural effects of psilocybin in individuals with mild declines in emotional wellbeing. Participants will receive one of four medication combinations (25 mg or 1 mg psilocybin with IV midazolam or IV saline).

Triple-blind, randomised, parallel-group Phase II trial (n=36) testing a single 25 mg vs 1 mg PEX010 psilocybin dose (2:1) in individuals on MAT for opioid use disorder to assess neural and clinical outcomes including urine drug screens and MAT adherence.

Open-label, single-group Phase II trial (n=15) of psilocybin-assisted therapy in US military veterans with PTSD: two oral psilocybin sessions (15 mg then 25 mg) plus preparatory and integration psychotherapy.

This randomised, blinded, Phase III trial (n=156) will investigate MDMA-assisted psychotherapy (weight-based dosing with supplemental doses) versus dexamfetamine-, lorazepam-, diphenhydramine-, or placebo-assisted psychotherapy for social anxiety in autistic young people.

This open-label, early Phase I trial (n=10) will assess the feasibility, safety, and preliminary efficacy of ketamine-assisted group therapy for Spanish-speaking adults with depression.

Non-randomised, single-group Phase II trial (n=10) assessing safety and acceptability of up to two 25 mg oral psilocybin administrations with therapeutic support in individuals with Bipolar II depression and suicidal ideation (second dose optional, 4 weeks apart).

Open-label, interventional mechanistic trial (n=120) using intravenous ketamine (0.5 mg/kg over 40 minutes, max 60 mg; three alternate-day infusions in MDD participants) to study molecular and connectome correlates of rapid antidepressant and anti-suicidal effects.

Single-site, randomised, controlled RCT (n=70) comparing ketamine-assisted psychotherapy (KAP) to standard medical ketamine (KET) for MDD over four weeks; ketamine doses personalised 0.3–1.0 mg/kg.

Single-arm pilot feasibility trial (n=12) of intramuscular ketamine (0.50–0.75 mg/kg IM, 3 doses ~once weekly) combined with manualised psychotherapy (7 sessions) for publicly insured patients with moderate-to-severe methamphetamine use disorder who have or are at-risk for HIV.

Randomised, quadruple-blind Phase II trial (n=86) comparing a single 25 mg oral dose of PEX010 (psilocybin) versus a 1 mg active placebo, both with cognitive behavioural therapy, for adults with stimulant use disorder.

This double-blind, placebo-controlled crossover trial (n=24) will investigate low-dose MDMA (25 mg or 50 mg) effects on oxytocin in patients with arginine vasopressin deficiency and matched healthy controls.

Triple-blind, placebo-controlled pilot RCT (n=10) assessing feasibility of psilocybin-assisted psychotherapy for severe IBS: single 25 mg oral psilocybin vs 100 mg niacin (active placebo) during guided psychotherapy with preparatory and integration sessions.

This interventional feasibility study (n=32) will evaluate the impact of oral psilocybin (10mg) combined with a 12-week group-based programme tailored for firefighters.

This Phase I/II randomised, triple-blind, placebo-controlled trial (n=20) will study the effects of sublingual 5-MeO-DMT (6 mg, administered weekly for four weeks) on anxiety, depression, and cognitive function in individuals with mild to moderate Alzheimer's disease.

Observational prospective study (n=200) using computer tasks, MEG/EEG and MRI to assess how serotonergic psychedelics (psilocybin, DMT, LSD, etc.) alter brain information processing in people receiving these compounds through Yale clinical trials.

This open-label, Phase I trial (n=12) will investigate the effects of different methods of esketamine administration (28 mg nasal spray vs. 28 mg oral solution) with and without CYP3A4 inhibitors (grapefruit juice or cobicistat) on drug absorption and metabolism.

Phase 1b single-group interventional study (n=20) testing a single 25 mg dose of psilocybin with manualized psychotherapy to reduce fear of cancer recurrence in women with early breast cancer or ovarian cancer in remission.

Single-masked, randomised controlled trial (n=60) comparing psilocybin (two high-dose oral sessions, 5–6 g each, six weeks apart), CBT (8–10 sessions), psilocybin-assisted CBT, and routine care in adults with MDD.

Pilot sequential study (n=44 planned; initial n=5 open-label pilot) assessing feasibility, acceptability, and safety of four twice-weekly IV ketamine infusions (0.5 mg/kg) followed by a brief narrative intervention versus minimally enhanced usual care in Veterans with chronic low back pain and depression.

Phase III, randomised, open-label, non-inferiority study (n=400) comparing IV racemic ketamine (up to 60 mg per infusion, max 8 lifetime doses) versus intranasal esketamine (56–84 mg per dose) for treatment-resistant depression.

This double-blind, placebo-controlled trial (n=45) will study the safety and efficacy of two dosage levels of intravenous (2R,6R)-Hydroxynorketamine (RR-HNK) in adults with obsessive-compulsive disorder (OCD).

Triple-blind, randomised, placebo-controlled Phase II feasibility trial (n=30) testing single-dose psilocybin 25 mg versus active placebo dextromethorphan 400 mg with psychological support in adults with chronic neuropathic pain.

Open-label Phase I study (n=20) assessing feasibility, tolerability and safety of psilocybin (10 mg safety dose then 25 mg treatment dose) with manualised psilocybin-assisted therapy in autistic adults with treatment-resistant depression.

This open-label trial (n=50) will assess the safety and efficacy of psilocybin-assisted psychotherapy in patients with treatment-resistant major depressive disorder (TRD) in an Australian clinical setting. Participants will receive two doses of psilocybin (25mg each) alongside a structured programme of preparatory and integration psychotherapy sessions over approximately 16–18 weeks.

Phase I single-group study (n=15) testing a second psilocybin-assisted group therapy session (oral psilocybin with optional booster) for anxiety/distress in partial responders with metastatic cancer.

Single-group interventional study (n=10) testing a single 25 mg oral dose of psilocybin with pre/post MRI in patients with treatment-resistant depression to assess effects on the positive valence system.

This open-label observational trial (n=20) will investigate the effects of intravenous ketamine on treatment-resistant bipolar depression, with an interventional component of functional magnetic resonance imaging (fMRI).

This randomised, quadruple-blind, placebo-controlled trial (n=24 planned; 16 actual reported) will evaluate the safety, tolerability, and pharmacokinetics of multiple doses of MLS101 (a low-dose psilocybin formulation) in healthy adult participants.

Open-label proof-of-concept trial (n=12) of two psilocybin sessions (25 mg then 25 mg or 35 mg) with psychological support for treatment-seeking people with Cannabis Use Disorder across a 12‑week course.

This observational cohort study (n=30) will explore how veterans aged 65 and older enrolled in VA healthcare perceive ketamine-assisted psychotherapy (KAP) for depression and end-of-life distress.

This Phase III randomised, double-blind, placebo-controlled trial (n=220) will study the efficacy, safety, and tolerability of CYB003 (16mg), a synthetic psilocybin analogue, compared to placebo as an adjunctive treatment for major depressive disorder (MDD).

This interventional trial (n=600) will evaluate whether cognitive training can enhance or extend the rapid antidepressant effects of ketamine in patients already receiving ketamine treatment as part of their clinical care.

Open-label single-group early phase I feasibility study (n=100) of flexible-dose (5–50 mg) intranasal ketamine self-administration over 8 weeks for depression and anxiety in palliative cancer patients.

Open-label single-group interventional study (n=4) assessing a single 25 mg oral dose of psilocybin with MRI pre/post to evaluate neural correlates of cognitive control in patients with PNES.

This randomised, quadruple-blind, placebo-controlled trial (n=40) will evaluate the safety, feasibility, and efficacy of psilocybin-assisted therapy in adults aged 18–65 with persistent post-concussion symptoms (PPCS). Participants will receive either a high dose (25mg) or a low dose (1mg) of psilocybin and undergo 5–6 weekly sessions of BrainACT, an adapted form of Acceptance and Commitment Therapy (ACT) for individuals with acquired brain injury.

This Phase I/II randomised, triple-blind, placebo-controlled trial (n=40) will investigate the safety, tolerability, and potential therapeutic effects of sublingual 5-MeO-DMT (6 mg, 9 mg, or 12 mg) in individuals with elevated symptoms of anxiety and depression. Participants will receive one dose per week for four weeks, with monitoring throughout the trial.

This double-blind, randomised, placebo-controlled trial (n=120) will investigate the interaction between psilocybin (up to 25 mg, oral) and the context of its administration in healthy volunteers with moderate-to-lower-than-average mental well-being.

This triple-blind, active placebo-controlled crossover trial (n=40) will assess nebulized ketamine (1.5 mg/kg; ~105 mg/70 kg) versus active placebo midazolam (0.03 mg/kg; ~2.1 mg/70 kg) for reduction of depressive symptoms in adult psychiatric inpatients with moderate to severe MDD.

Phase I randomised, blinded crossover PK/bioavailability study (n=34) comparing R-107-H (3×60 mg) versus R-107-P (3×60 mg) in healthy volunteers under fasting conditions.

Open-label, within-subjects dose optimisation trial (n=60) in U.S. veterans with PTSD investigating the optimal number of MDMA-Assisted Therapy cycles (one MDMA session + three integration sessions).

Open-label, randomised feasibility trial (n=24) comparing psilocybin microdosing alone versus microdosing plus meditation in healthy adults; four supervised microdoses over two weeks.

This single-arm, Phase I/II pilot trial (n=30) will test psilocybin-assisted psychotherapy (25mg x 2 doses, 4 weeks apart) for treatment-resistant obsessive-compulsive disorder (OCD), body dysmorphic disorder (BDD), and anorexia nervosa (AN).

This observational trial (n=15) will evaluate a novel Virtual Reality Psychedelic (VRP) called DeepDream using the Meta Quest 3 device.

This randomised, quadruple-blind, placebo-controlled Phase I/II trial (n=50) will investigate the antidepressant, psychedelic, and adverse effects of Psilocybe cubensis mushrooms (equivalent to 30 mg of psilocybin) with or without daily fluoxetine (20mg) in adults with treatment-resistant depression.

Open-label, non-randomised Phase IV pilot (n=20) evaluating safety and feasibility of manualised 4-session CBT with three adjunctive subcutaneous ketamine doses (weekly, weeks 2–4) for adults with methamphetamine use disorder.

This randomised, quadruple-blind, placebo-controlled Phase III trial (n=60) will study the early effects of ketamine compared to placebo as an adjunctive therapy with venlafaxine in inpatients with severe unipolar major depressive disorder (MDD).

Randomised, crossover study (n=30) comparing 15 mg oral psilocybin with placebo in healthy volunteers to assess effects on brain synchrony and cognition during film viewing.

This interventional trial (n=50) will explore mechanisms of psilocybin in migraine and healthy controls using a randomized, parallel, quadruple-blind design with oral psilocybin 10 mg versus 2.5 mg THC control.

This double-blind, randomised, Phase II trial (n=90) will evaluate the efficacy of psilocybin-assisted therapy (25 mg x2) versus niacin (250 mg x2) plus therapy to reduce heavy drinking days in people with Alcohol Use Disorder.

This open-label, Phase II trial (n=16) will assess the feasibility, tolerability, and preliminary efficacy of psilocybin (25 mg) therapy for adults with chronic neuropathic pain and treatment-resistant depression (TRD).

This open-label, proof-of-concept pilot study (n=12) will assess the efficacy and safety of midomafetamine (MDMA)-assisted therapy (MDMA-AT) with three monthly experimental dosing sessions (80 mg first; 120 mg second and third; optional 50% supplemental dose).

Randomized, double-blind, placebo-controlled crossover Phase II trial (n=50) testing IV (2R,6R)-HNK infusions (0.25→2.0 mg/kg, up to four infusions over 2 weeks) versus saline placebo in treatment-resistant MDD.

This observational pilot study (n=10) will examine salivary oxytocin levels during a single dose of LSD as part of psychedelic-assisted psychotherapy (PAP) for anxiety disorders or depression.

Open-label, non-randomised single-group fMRI study (n=10) testing a single oral 20 mg psilocybin dose versus baseline to assess changes in brain response to food choice and reward in healthy adults.

This Phase II interventional trial (n=12) will evaluate the effects of psilocybin (25 mg) with and without risperidone (1 mg) on synaptic density in adults with treatment-resistant depression (TRD).

This interventional trial (n=5) investigates the safety and feasibility of ketamine-assisted psychotherapy in adolescents with posttraumatic stress disorder (PTSD).

This randomised, double-blind, placebo-controlled trial (n=120) will study the efficacy of intravenous (IV) ketamine versus IV midazolam in treating adults with moderate to severe methamphetamine use disorder (MUD).

Open-label, single-group feasibility study (n=20) evaluating group psilocybin-assisted therapy (two psilocybin sessions) for low-income adults with major depression in Oregon.

Open-label, single-arm proof-of-concept study (n=30) evaluating neurobiological effects of a single 25 mg oral psilocybin dose with accompanying psychotherapy in treatment-resistant bipolar depression (BD-II).

This interventional trial (n=12) will assess the feasibility and acceptability of administering a single 25 mg oral dose of psilocybin to healthy Māori volunteers in a marae setting under clinical supervision (open-label, single-group, Phase I).

This open-label trial (n=15) will evaluate the feasibility, tolerability, safety, and efficacy of psilocybin-assisted (25mg) cognitive processing therapy for chronic Posttraumatic Stress Disorder (PTSD).

This single-blind interventional trial (n=20) will investigate the safety of ascending doses of psilocybin for home administration.

This interventional controlled study (n=20) will evaluate GPM-Complex psychotherapy with or without 2–5 MDMA-assisted sessions (initial 80 mg with optional 40 mg supplemental dose) for treating PTSD in individuals with co-occurring BPD.

This Phase I, open-label trial (n=6) investigates how psilocybin (COMP360; 10mg) is absorbed, distributed, metabolised, and excreted in healthy male volunteers aged 30-55.

This double-masked, active placebo-controlled, single-dose randomised trial (n=80) will investigate the effects of intravenous (IV) ketamine versus remimazolam for depression in Veterans with Parkinson’s disease (PD).

This randomised, open-label, parallel arm trial (n=40) will examine the potential synergy between psilocybin (25 mg, single dose) and 8 weeks of mindfulness training versus psilocybin alone in healthy adults.

This double-blind, randomized, placebo-controlled Phase II trial (n=200) investigates the therapeutic neural mechanisms of psilocybin (30mg) in patients with alcohol use disorder (AUD).

This open-label, Phase Ib clinical trial (n=50) will investigate the safety, feasibility, and tolerability of a single dose of oral psilocybin (25 mg) in individuals with functional impairment due to psychiatric symptoms, including mood, anxiety, trauma, or addiction.

This randomised controlled trial (n=60) will assess the efficacy of oral psilocybin therapy for depression in individuals with Parkinson’s disease.

Randomized, double-blind, parallel Phase II trial (n=30) testing psilocybin-assisted psychotherapy (25 mg, two sessions) versus niacin placebo for depression and/or anxiety in patients with advanced cancer.

This randomised, double-blind, midazolam-controlled, multicentre trial (n=98) will investigate the efficacy and safety of low-dose subcutaneous ketamine in adults with bipolar depression.

This Phase IV, placebo-controlled crossover trial (n=35) will investigate the impact of ketamine on perceptual decision-making in healthy volunteers.

Randomised, parallel-arm trial (n=6 actual) comparing concurrent behavioural activation therapy plus intranasal esketamine versus esketamine alone for treatment-resistant depressive episodes in MDD or BD.

Prospective case-control observational study (n=150) comparing single-dose IV ketamine (0.5 mg/kg), ketamine plus midazolam, and saline placebo in patients undergoing caesarean section to evaluate postpartum depression and postoperative outcomes.

Randomised, double-blind, within-subject crossover study (n=16 actual) assessing single-dose intranasal esketamine 56 mg versus placebo on dynamic brain glutamate release, resting-state connectivity, and vision in healthy volunteers.

This open-label randomized trial (n=50) will assess the safety of ketamine plus propofol sedation versus standard-of-care analgosedation in ICU patients with severe TBI.

Open-label, single-group Phase II study (n=65) evaluating safety, tolerability, and pharmacokinetics of Ketamine HCl PR tablets (start 40 mg BID; may increase to 80 mg BID) in adults with CRPS-related pain.

This Phase II open-label trial (n=15) will study Psilocybin-assisted Existential, Attachment and Relational (PEARL; 25mg) therapy for patients with advanced cancer.

Double-blind, randomised, active-comparator trial (n=80) comparing single-dose psilocybin (30 mg) versus weight-based ketamine (0.75 mg/kg) with psychotherapy in adults with moderate–severe AUD.

Single-group interventional Phase II study (n=40) of psilocybin therapy for refractory Anorexia Nervosa in young adults with two dosing sessions (20 mg then up to 30 mg) plus preparatory and integration therapy.

This Phase II interventional trial (n=30), will investigate the efficacy of nitrous oxide in alleviating suicidal ideation (SI).

Double-blind, randomized 1:1:1 Phase 2b dose-comparison trial (n=84) comparing single oral 25 mg, 10 mg and 1 mg PEX010 plus psychotherapy for adjustment disorder due to an incurable cancer diagnosis.

Phase I, open-label, non-randomised dose-escalation study (n=9) assessing safety and PK of a single 140-minute IV infusion of TRP-8803 (psilocin; 7.5, 14, or 20.5 mg) in healthy adults.

Randomised, triple-blind, parallel-group trial (n=204) testing a single 0.2 mg/kg IV esketamine injection versus 5 ml 0.9% saline in females undergoing surgical abortion with sleep disturbance.

This double-blind, active-controlled study (n=36) aims to evaluate the preliminary clinical efficacy, safety, tolerability, and pharmacokinetics of CYB004 (DMT) in participants diagnosed with Generalized Anxiety Disorder (GAD) with depressive symptoms.

Randomized, parallel-group pilot (n=20) testing psilocybin therapy (25 mg initial; second dose conditional up to 40 mg) for adults with chronic PTSD on an SSRI, comparing trauma-focused psychotherapy versus standard psychological support.

This randomised, triple-blind, placebo-controlled crossover trial (n=18) will investigate the acute analgesic (anti-pain) effects of N,N-dimethyltryptamine (DMT) on experimentally induced acute nociceptive pain, hyperalgesia, and allodynia in healthy participants.

Randomised, quadruple-blind, parallel-group trial (n=116) assessing intraoperative IV esketamine 0.3 mg/kg versus saline on consciousness measures in patients with prolonged disorders of consciousness undergoing surgery under sevoflurane anaesthesia.

Randomised, quadruple-blind, Phase II trial (n=60) comparing ketamine (0.5 mg/kg IV, 6 infusions over 3 weeks) plus CBASP or TAU versus placebo plus CBASP in patients with stage-2 treatment-resistant chronic depression.

Single-group interventional study (n=20) conducting repeated neurocognitive and neurobiological measurements in unipolar depressed patients, with a ketamine substudy using a single 0.5 mg/kg IV infusion.

Prospective randomised pilot trial (n=30) comparing outpatient IV ketamine (0.5 mg/kg/hr) vs ketamine+magnesium vs magnesium control in military patients with chronic neuropathic pain; PTSD outcomes are secondary.

Open-label case series (n=25) assessing feasibility of Perinatal SMILES (interpersonal psychotherapy plus two subcutaneous ketamine doses ~24 h apart) to improve post-cesarean mood in low-income women.

Double-blind, active-control randomised study (n=40) comparing a single 25 mg psilocybin dose to 40 mg methylphenidate in people with chronic low back pain and depression to assess safety, feasibility and effects on pain-related mechanisms.

Phase III randomised, parallel-group trial (n≈23) comparing one vs two 25 mg psilocybin-assisted therapy sessions for treatment-resistant depression with preparatory and integration therapy.

Randomised, quadruple‑blind, active‑placebo controlled Phase II trial (n=100) comparing a single 25 mg oral dose of psilocybin to 1 mg in patients with cancer‑related MDD (age 20–80).

This open-label, prospective trial (n=150) will investigate the safety, tolerability, analgesic effect, and feasibility of intranasal sufentanil/ketamine (CT001) in paediatric patients with moderate or severe pain attending an acute care setting, such as an emergency department following an injury.

This interventional trial, led by The George Institute, aims to compare the effectiveness of two formulations of ketamine (esketamine (Spravato®) and racemic ketamine), in treating treatment-resistant depression (TRD).

Multicentre, randomised, non-inferiority, parallel-group open-label trial (n=340) comparing six adjunctive IV esketamine infusions (0.2 mg/kg, 40-minute infusion, three times/week) versus six ECT sessions over two weeks for reduction of suicidal ideation in depressive episodes.

Open-label, single-group feasibility study (n=10) of two 25 mg psilocybin sessions given two weeks apart with supportive psychotherapy for treatment-resistant OCD.

Open-label feasibility study (n=100) of two 25 mg psilocybin sessions with preparatory and integration psychotherapy for hospitalized patients with treatment-resistant depression.

This parallel assignment interventional trial (n=34 planned; 1 enrolled per registry) assesses whether pre‑treatment presentation and a post‑treatment follow-up improve expectation and response to esketamine for depressive episodes.

This open-label interventional trial (n=20) will assess the effects of a single dose of psilocybin (25 mg COMP360) on rumination and its neural correlates in individuals with major depressive disorder (MDD).

This double-blind, randomized, placebo-controlled trial (n=35) will investigate the impact of psilocybin (5–10 mg) on pain perception in fibromyalgia patients.

Open-label, single-group Phase I feasibility study (n=10) of psilocybin-assisted psychotherapy (one 5 mg then two 25 mg oral doses) for body image disturbance in women with prior anorexia nervosa.

This randomized, controlled trial (n=1254) investigates the effect of an intensified pharmacological treatment (including ketamine/esketamine and clozapine) for schizophrenia, major depressive disorder (MDD), and bipolar depression in subjects who experienced a first-time treatment failure on their first-line treatment.

Open-label, randomised, parallel trial with blinded raters (n=418) comparing early-intensified pharmacological treatment including esketamine or ketamine (twice-weekly for 4 weeks) plus a second-line antidepressant versus treatment as usual in adults (18–65) with MDD and first-line treatment failure.

This observational cohort study will characterise the temporal profile of the anti-nociceptive effect of an intravenous ketamine bolus using the Nociception Analgesia Index (ANI).

Double-blind, randomized, placebo-controlled Phase II outpatient trial (n=90) evaluating CLE-100 (oral esketamine) 1 tablet once daily adjunctive to standard antidepressant therapy for 4 weeks in adults with MDD and inadequate response to ≥2 antidepressants.

This double-blind, randomized, placebo-controlled, parallel-group laboratory trial (n=63) conducted by Yale University aims to determine the effects of DMT (14-21mg/70kg/min) infusions, in conjunction with psychotherapy, on Alcohol Use Disorder (AUD).

Randomised, double-dummy, triple-blind, placebo-controlled, parallel groups trial (n=90) investigating sublingual LSD microdosing (2–20 µg, start 8 µg) twice weekly for 8 weeks versus active placebo (caffeine or methylphenidate) in people with MDD.

This Phase III, randomised, triple-blind, multicentre trial (n=240) compares single oral psilocybin 25 mg, psilocybin 5 mg, and inactive placebo in adults with Major Depressive Disorder using a Set and Setting psychosocial support protocol.

This Phase I interventional, randomized, quadruple-blind, placebo-controlled study (planned n=80; ACTUAL 24) will assess safety, tolerability and pharmacokinetics of low-dose psilocybin (MLS101) in healthy adults using SAD and MAD cohorts.

This pilot, double-blind, placebo-controlled randomised clinical trial (n=50) led by Brigham and Women's Hospital assesses safety and preliminary efficacy of IV ketamine (0.8 mg/kg over 40 minutes) for individuals with opioid use disorder and suicidal ideation in the emergency department.

Randomised, quadruple-blind, parallel Phase II trial (n=40) comparing IV ketamine 0.5 mg/kg vs midazolam 0.045 mg/kg twice weekly for 3 weeks in Veterans with mild–moderate TBI and comorbid PTSD and MDD to evaluate efficacy and safety.

This single-arm open-label trial (n=20) will assess the efficacy of MDMA-assisted psychotherapy for fibromyalgia patients.

This open-label trial (n=15) will assess feasibility, safety and preliminary efficacy of MDMA-assisted therapy (three monthly MDMA sessions with preparatory and integrative therapy) for postpartum people with co-occurring PTSD and Opioid Use Disorder.

Randomised, triple-blind Phase I factorial trial (n=108 planned) testing whether adjunctive taVNS enhances the long-term beneficial effects of a single open-label 25 mg psilocybin dose in medically healthy adults with modest reductions in wellbeing.

Randomised, quadruple‑blind, parallel Phase II trial (n=40) comparing a single 25 mg oral psilocybin dose versus a 1 mg active‑placebo with psychological support to treat anhedonia in treatment‑resistant MDD.

Open-label, single-arm Phase II proof-of-concept trial (n=16) evaluating two 25 mg psilocybin doses delivered with motivational enhancement/supportive therapy for adults with moderate–severe Cannabis Use Disorder.

This Phase II parallel assignment interventional trial (n=150) is conducted by Stanford University. The study aims to comprehend how ketamine functions in the brain to reduce symptoms of Obsessive-Compulsive Disorder (OCD).

This randomized, double-blinded, crossover trial (n=30) aims to characterise the effects of low doses of LSD on behavioural and neural indicators of feedback and feedforward signalling in perceptual decision-making.

Randomised, parallel-group trial (n=60) comparing MDMA-Assisted Therapy (three 8‑hour MDMA sessions with preparatory/integration therapy) versus an intensive somatic experiential therapy (SEA-IT) in male veterans with PTSD and moral injury.

This double-blind, controlled trial (n=90) aims to investigate the effect of a single high dose of psilocybin therapy (30mg) versus a very low dose (1mg) as an adjunctive therapy to individuals undergoing standard-of-care outpatient buprenorphine treatment for Opioid Use Disorder (OUD).

Randomised, double-blinded, Phase II adaptive 4-arm parallel trial (n=140) comparing three psilocybin regimens with dexamfetamine control; three oral dosing sessions (psilocybin 25 mg or dexamfetamine 7.5 mg) delivered 2–4 weeks apart with structured psychotherapy.

This placebo-controlled, double-blind, parallel-group interventional trial (n=120) aims to explore the effects of combining ketamine with real-time functional magnetic resonance imaging (fMRI) neurofeedback training in individuals with cocaine use disorder (CUD).

Randomized, parallel Phase II trial (n=92) comparing one versus two psilocybin doses (25 mg) with psilocybin-assisted psychotherapy in adults with treatment-resistant depression; first dose randomised 1 mg vs 25 mg, second dose open-label 25 mg.

Randomized, open-label, active-comparator controlled trial (n=20) comparing psilocybin-assisted psychotherapy (25 mg oral) vs ketamine-assisted psychotherapy (200 mg oral) in males with moderate or severe alcohol use disorder.

This randomised, double-blind, placebo-controlled crossover trial (n=20) conducted by the University Hospital in Basel, Switzerland, aims to investigate the effects of ketanserin, olanzapine, and lorazepam administered after LSD (150µg) on the acute response to LSD in healthy subjects.

This early Phase I interventional trial (n=10) will assess the neurophysiological effect of ketamine in patients with severe Traumatic Brain Injury (TBI).

This early-Phase I interventional trial (n=10) aims to assess the safety profile of psilocybin (25mg) in individuals with cocaine use disorder (CUD).

This interventional trial (n=10) will explore the impact of audiovisual stimuli using virtual reality on the tolerability and effectiveness of ketamine/esketamine treatment for depressive episodes.

This interventional trial (n=120) aims to explore the neural circuit-specific mechanisms of ketamine's effect on anhedonia and anxiety in individuals with major depressive disorder (MDD).

Phase I, randomised, single-blind crossover FDG-PET study (n≈17) assessing acute cerebrometabolic effects of an oral harmine+DMT formulation versus placebo in healthy male volunteers.

This observational cohort study (n=450) will compare the long-term effectiveness, safety, and patient satisfaction of intravenous (IV) ketamine versus intranasal esketamine (Spravato) for treating major depressive disorder (TRD).

Randomized, double-blinded, midazolam-controlled crossover trial (n=40) testing single IV ketamine (0.5 mg/kg over 40 minutes) versus midazolam (30 µg/kg) in treatment-resistant depression to identify predictors of rapid and sustained response.

This open-label randomized waitlist-controlled pilot study (n=14) tests two 25 mg oral doses of TRP-8802 (psilocybin) with psychotherapy in adults with treatment-resistant IBS.

This double-blind, randomized, placebo-controlled trial (n=62) aims to determine the feasibility and preliminary clinical efficacy of psilocybin-assisted therapy (30mg) as a complementary intervention during inpatient rehabilitation for severe alcohol use disorder (AUD).

This double-blinded, randomized, placebo-controlled, parallel-arm pilot trial (n=20) will investigate the efficacy of intravenous ketamine (0.5 mg/kg IV) versus saline for emergency department treatment of suicidal ideation in adolescents.

Phase II, randomised, quadruple-blind trial (n=110) comparing i-CBT plus six IV ketamine infusions versus i-CBT plus six IV midazolam infusions to reduce suicidality in treatment-resistant depression.

Randomized, quadruple-blind Phase III parallel pilot (n=20) evaluating MDMA-assisted Massed Prolonged Exposure (one MDMA medicine session plus 12 90-minute PE sessions) in US veterans with PTSD; doses randomized (exact doses not disclosed).

This interventional trial (n=400) investigates the effect of esketamine infusion during laparoscopic sleeve gastrectomy on postoperative depressive symptoms among obese patients.

Single-group study (n=12) of a single oral psilocybin dose (20–25 mg, weight-based) assessing synaptotrophic effects with pre/post [11C]-UCB-J PET and fMRI in detoxified individuals with opioid use disorder (OUD).

Phase I interventional study (n=100) using ketamine-induced gamma band potentiation (GBP) in healthy, MDD and TRD groups to prognose 4-week antidepressant outcome across an induction course.

This triple-blinded, randomised, active placebo-controlled trial (n=34) will investigate IV ketamine (0.8 mg/kg, four infusions over two weeks) versus midazolam in adults with moderate depression and alcohol use disorder admitted for inpatient addiction therapy.

This double-blind, placebo-controlled trial (n=65) will assess the efficacy and safety of LSD (25μg) every 3 days for 3 weeks versus placebo in treating chronic cluster headaches (CCH).

This Phase IV interventional trial (n=40) aims to investigate the efficacy and safety of MDMA (84-100mg) in combination with Prolonged Exposure therapy (PE) for individuals with posttraumatic stress disorder (PTSD).

This randomised, controlled clinical trial (n=128) aims to investigate whether a single dose of psilocybin administered with motivational enhancement therapy (MET) can reduce heavy drinking in patients with alcohol use disorder (AUD).

Randomised, quadruple-blind, parallel pilot trial (n=30) testing two oral administrations of psilocybin (25 mg) versus inactive 1 mg control, given 3 weeks apart, for AUD with comorbid depression alongside usual care.

This open-label, single-group assignment trial (n=15) aims to assess the feasibility, safety, and preliminary efficacy of psilocybin-assisted therapy for opioid-refractory pain in patients with advanced cancer.

This open-label trial (n=24) aims to investigate the impact of a single dose of psilocybin (25mg), administered with therapeutic support, on the default mode network (DMN) in individuals with Functional Neurological Disorder (FND).

Phase II, randomised 2x2 factorial study (n=100) testing COMP360 psilocybin (25 mg vs 1 mg) combined with active or sham accelerated iTBS (SAINT/SNT) in treatment-resistant MDD.

This single-arm, open-label trial (n=14) will investigate the effects of Ketamine Assisted Psychotherapy (KAP) on individuals with Post Traumatic Stress Disorder (PTSD).

This randomized, double-blind, placebo-controlled study (n=160) aims to evaluate the safety, tolerability, and efficacy of Psilocybin-Assisted Psychotherapy (APEX-002-A02) in treating severe depression among adults with Post-Traumatic Stress Disorder (PTSD).

This interventional trial (n=30) will assess the efficacy and safety of MDMA-assisted psychotherapy for PTSD with 2–3 oral MDMA medicine days (120 mg + 60 mg top-up typical) alongside preparatory and integration psychotherapy.

This retrospective registration trial investigates the effectiveness of psychedelic therapy for Treatment Resistant Depression (TRD).

Randomised Phase II neuroimaging crossover trial (n=50) testing oral psilocybin 25 mg versus microcrystalline cellulose placebo in participants with depressive disorder; two treatment sessions with MRI assessments and supportive psychotherapy.

This double-blind, placebo-controlled Phase II trial (n=50) will investigate the effects of intravenous ketamine infusions on patients with depressive symptoms in the intensive care unit (ICU).

This interventional trial (n=50) conducted by the University of Kansas Medical Center will assess the feasibility and safety of administering a single dose of ketamine to acutely suicidal patients in the Emergency Department.

Double-blind, controlled trial (n=90) comparing a single high-dose psilocybin session (30 mg) versus a very low dose (1 mg) as adjunctive therapy to standard buprenorphine treatment for OUD.

This PhaseII interventional trial (n=40), titled “MDMA-Assisted Cognitive Behavioral Therapy (CBT) Compared With Methamphetamine-Assisted CBT in Obsessive-Compulsive Disorder (OCD): A Phase II Study,” aims to assess the safety and preliminary effectiveness of MDMA-assisted cognitive behavioral therapy in participants diagnosed with obsessive-compulsive disorder (OCD).

This phenomenological exploration trial (n=15) aims to investigate the transient dissociative state induced by esketamine in patients with depressive disorder.

Randomized, quadruple-blind, parallel-group trial (n=30) testing single oral psilocybin doses (1–30 mg) combined with zolpidem, modafinil, both, or placebo for adults with chronic low back pain.

This observational cohort study (n=128) will evaluate the sustained effectiveness of intravenous (IV) ketamine for suicidal ideation in adults experiencing a suicidal crisis due to major depressive disorder.

This observational, case-only study (n=25) will investigate the self-administered therapeutic use of psychedelics in people with psychiatric disorders.

This Phase II interventional trial (n=60) aims to investigate whether psilocybin affects synaptic vesicular density (SVD) in individuals with amnestic Mild Cognitive Impairment (aMCI) compared to healthy participants.

This double-blind, randomized, dose-response trial (n=15) aims to assess the pharmacokinetic and pharmacodynamic profiles of RE02, a psychedelic drug, in healthy subjects.

Phase I triple-blind, random-order, 3-period crossover in healthy volunteers (n=25) comparing MDMA 120 mg + 60 mg booster (2 h), MDMA 120 mg + placebo, and placebo + placebo to assess duration of acute subjective, physiological and endocrine effects.

This interventional trial (n=3) will assess the efficacy and safety of esketamine for the treatment of Rett Syndrome (RTT) in children aged 5 to 10 years.

This single-arm, open-label trial (n=15) assesses feasibility, acceptability and safety of psilocybin-assisted supportive psychotherapy (single 25 mg oral psilocybin session) for prolonged grief disorder in bereaved cancer carers.

Early‑Phase interventional dose-ranging study (n=40) assessing LSD single doses (25–200 µg) to quantify 5‑HT2A receptor occupancy in healthy participants using [11C]CIMBI‑36 PET/MR.

This randomised controlled trial (n=45) evaluates a 55-minute psychedelic-like VR intervention (Psyrreal) versus a non-psychedelic VR analogue and a conditional waitlist in adults with clinical depression.

Open-label pilot, single-arm Phase II study (n=10) evaluating safety and feasibility of an 8-week psilocybin-assisted psychotherapy intervention (25 mg plus optional 37.5 mg) to support opioid tapering in adults with chronic pain.

Open-label, non-randomised Phase I single-group study (n=20) testing psilocybin-assisted psychotherapy (initial 15 mg oral dose, up to 45 mg) for treatment-resistant depression in patients on stable psychotropic medication.

This open-label trial (n=0; withdrawn) was designed to investigate the viability of ketamine-assisted psychotherapy in treating emotional distress related to cancer.

This naturalistic, open-label, single-arm intervention trial (n=162) conducted by Royal North Shore Hospital assesses add-on intranasal esketamine (Spravato) for adults with major depressive disorder.

Open-label, parallel-group, randomised trial (withdrawn; ACTUAL n=0) comparing adjunctive intranasal esketamine versus adjunctive aripiprazole in veterans with treatment-resistant depression over up to 6 months; primary endpoint remission at 6 weeks.

Pilot double-blind, placebo-controlled randomised clinical trial (n=50) testing a single IV ketamine infusion (0.8 mg/kg over 40 minutes) versus saline in adults with severe alcohol use disorder seeking inpatient detoxification in the ED to assess safety and preliminary efficacy.

This Phase I intervention trial (n=120) investigates whether stimulating the serotonin system influences pro-social behaviour compared to stimulating the dopamine system in healthy individuals; single-dose psilocybin (15 mg), MDMA (100 mg) or methylphenidate (60 mg) in a double-blind randomized parallel design.

This observational cohort study (n=40), conducted by Yale University, aims to explore the long-term effects of ketamine for treating depression in Parkinson's disease (PD) and assess the impact of Cognitive Behaviour Therapy (CBT) on maintaining the effects of ketamine.

This open-label trial (n=15) will assess the safety and tolerability of a single sub-anesthetic (0.5 mg/kg) intravenous ketamine treatment in individuals aged 50–90 with mild cognitive impairment and depression (MCI-D).

This uncontrolled, single-arm, naturalistic study (n=162) aims to evaluate the positioning of Esketamine Treatment (PoET) for symptom management in adults with major depressive disorder (MDD).

This interventional trial (n=60) aims to assess the efficacy and safety of MDMA-Assisted Cognitive-Behavioural Conjoint Therapy (CBCT) compared to CBCT alone in dyads where one member has Post-Traumatic Stress Disorder (PTSD).

This open-label clinical trial (n=12) aims to assess the feasibility of ketamine-assisted psychotherapy (KAP) for adults with non-operable gastrointestinal (GI) cancers suffering from existential distress.

Double-blind, randomised, controlled perioperative trial (n=200) evaluating a single subanesthetic esketamine dose to reduce postoperative anxiety and depression in adolescents undergoing elective surgery.

Double-blind, randomised, parallel Phase II trial (n=293) of oral psilocybin microdosing (4 mg, 11 doses over six weeks) versus caffeine (60 mg) for moderate major depressive disorder.

Open-label Phase II single-group study (n=14) assessing ascending inhaled DMT (15 mg then 60 mg on a single day) for patients with partial response in depression.

Open-label single-group pilot (n=16 dyads, 8 PTSD+ veterans and their partners) testing MDMA-assisted bCBCT: 8-session therapy with two full-day MDMA sessions for PTSD+ veterans to evaluate preliminary effectiveness on PTSD and relationship functioning.

Non-randomised single-group pilot (n=16) assessing IV ketamine 0.5 mg/kg (40-minute infusions, four weekly doses) combined with Radically Open DBT in adults with treatment-resistant depression.

Randomised, parallel-group trial (n=60) comparing oral ketamine plus Behavioural Activation Therapy (BAT) vs oral ketamine plus treatment as usual in adults with treatment-resistant major depressive disorder; oral ketamine initial 0.5 mg/kg (up to 2 mg/kg) sipped over 30–60 minutes.

Randomized, open-label, single-blind, non-inferiority Phase IV comparative effectiveness trial (n=1500) comparing ECT versus subanesthetic IV ketamine (0.5 mg/kg) for rapid treatment of acute suicidal depression.

This open-label, non-randomized Phase IIa trial (n=18) evaluates the feasibility and safety of MDMA-assisted group therapy for treating PTSD in veterans. Conducted by the Portland VA Research Foundation, the study employs a unique treatment package comprising two once-monthly open-label MDMA sessions combined with non-drug preparatory and integrative therapy, both individual and group-based.

This randomized, double-blind, single-site Phase II trial (n=40) will investigate MDMA-assisted therapy’s safety and preliminary efficacy compared with low dose d-amphetamine-assisted therapy on the severity of PTSD symptoms in veterans with at least moderate PTSD severity.

Open-label, Phase I dose-ranging safety study (n=12) in healthy adults testing single oral doses of SM-001 (0.5, 1.0, 2.0 mL/kg) to assess safety and plasma biomarkers.

This Phase IV interventional trial (n=60) aims to investigate the effectiveness of intraoperative ketamine in reducing postoperative depressive symptoms in patients undergoing lumbo-peritoneal shunt insertion.

This non-randomized trial (n=100) investigates the psychological, cognitive, and physiological effects of a single session of psychedelic drug exposure with either psilocybin or MDMA in a group setting.

This Phase II interventional trial (n=120) explores the effectiveness of MDMA-assisted (80–160 mg per session, with possible supplemental doses) prolonged exposure therapy (COPE) versus niacin control in individuals with comorbid PTSD and alcohol use disorder.

This randomised, blinded, placebo-controlled, parallel-group pilot and feasibility trial (n=400) will investigate the efficacy and safety of using esketamine for the treatment of patients with severe acute brain injury. It will specifically focus on cortical spreading depolarisations (SDs) in TBI, aSAH, or ICH.

This quadruple-masked, randomised, multi-centre Phase II study (n=225) investigates the efficacy and safety of a single intranasal dose of BPL-003, combined with psychological support, in patients with treatment-resistant depression (TRD).

Randomised parallel Phase I/II pilot (n=24) comparing a single 15 mg versus 25 mg oral psilocybin dose paired with physiotherapy for refractory motor FND to assess safety and preliminary efficacy.

Randomised interventional trial (n=60) comparing psilocybin-assisted psychotherapy with family-member involvement versus PAP with therapists only; two 25 mg oral psilocybin sessions 3 weeks apart in adults with treatment‑resistant MDD.

Phase I single-group intervention (n=30) evaluating enhanced psilocybin microdosing (0.15–0.33 g dosing; monthly 1–1.5 g maintenance) for chronic conditions including PTSD, chronic depression, MS, HIV and Long COVID.

This Phase I interventional study (n=64) assesses feasibility of a resilience-focused 10-week community of practice programme incorporating one group-administered psilocybin-assisted therapy session for patients with end-of-life distress.

Single-blind, non-randomised, single-group repeated-measures study (n=15) testing IM 5‑MeO‑DMT (3, 6, 9 mg) and saline placebo across four sessions to assess MEG/fMRI markers and wellbeing.

Randomised, quadruple-blind, active-placebo controlled parallel trial (n=60) testing two oral LSD sessions (100 µg then 100/200 µg) versus low-dose LSD active-placebo (25 µg ×2) for psychosocial distress in patients with end-stage disease.

This randomized, interventional trial (n=30) will compare MDMA-assisted Cognitive Processing Therapy (three MDMA sessions plus preparatory and integration therapy) versus standard Cognitive Processing Therapy for Veterans with severe PTSD.

This open-label, Phase II trial (n=18) will investigate the safety and preliminary effectiveness of MDMA-assisted therapy (MDMA-AT) in military veterans with co-occurring Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD).

Phase I/II single-group trial (n=55 actual) of oral psilocybin plus group and individual therapy for anxiety and/or depression in patients with metastatic cancer to assess safety and side effects.

This double-blind, randomised, controlled trial (n=280) will investigate the efficacy of ketamine-assisted psychological therapy in severe alcohol use disorder (AUD) patients.

Randomised, parallel Phase II trial (n=162) comparing two ketamine IV doses (0.2 mg/kg and 0.5 mg/kg; two infusions) vs midazolam (active comparator) combined with week-long trauma-focused psychotherapy for chronic PTSD.

This open-label pilot trial (n=20) aims to evaluate the tolerability and feasibility of LSD microdosing in patients with major depressive disorder (MDD).

This observational cohort study (n=540) aims to gather unified data from a large cohort of patients with Major Depressive Disorder (MDD) undergoing various treatment (including ketamine & esketamine) options to identify optimal biomarkers for depression treatments at the individual patient level.

This randomised, double-blind, 3-arm Phase II trial (n=160) compares three 25 mg psilocybin sessions vs two 25 mg psilocybin + one placebo session vs three placebo sessions, all paired with preparatory and integrative psychotherapy for treatment-resistant depression.

This interventional randomised, blinded, parallel Phase II trial (n=40) compares MDMA-assisted psychotherapy (3 × 100 mg oral sessions) to psilocybin-assisted psychotherapy (3 × 25 mg oral sessions) for treatment-resistant OCD, with preparatory and integration therapy.

This double-blind, randomised, parallel Phase II trial (n=32) compares single-dose MDMA-assisted therapy (120 mg, optional 60 mg supplemental) versus methylphenidate-assisted therapy (20 mg, optional 10 mg supplemental) for depressive and anxiety symptoms in people with advanced-stage cancer.

Early Phase I randomised crossover study (n=33 actual) testing whether MDMA (100 mg) produces greater prosocial effects when administered with a familiar versus unfamiliar partner in healthy volunteers.

This interventional trial (n=12) assesses safety and tolerability of psilocybin-assisted physiotherapy (three oral sessions, 5-20 mg Williams design) in healthy volunteers.

This Phase II, single-center trial (n=56) investigates the efficacy, safety, and tolerability of up to two doses of psilocybin (25mg) administered at an interval of 9 to 10 weeks in patients with Major Depressive Disorder (MDD) and cancer.

Open-label, non-randomised interventional study (n=5) assessing safety and feasibility of three cycles of MDMA-assisted psychotherapy (87 mg initial dose + 43.5 mg supplemental) in patients with PTSD.

This open-label, Phase IV interventional trial (n=205) compares mescaline sodium enteric-coated tablets versus morte-mescaline, each given with glucocorticoids, for treatment of adult lupus nephritis in real-world settings with induction and maintenance phases.

This observational cohort study (n=20) aims to investigate the impact of a combined protocol of subanesthetic ketamine infusions (SKI) and bilateral cervical sympathetic blocks (CSB) on ageing in Special Operations Forces (SOF) members undergoing treatment for PTSD/TBI.

Observational prospective study (n=8 actual enrolled) assessing EEG, pupillometry and belief-updating before and after clinically prescribed esketamine (intranasal 28–84 mg) in people with MDD.

Single-group, single-blind Phase I interventional study (n=30) of psilocybin-assisted psychotherapy with three oral dosing sessions (1 mg then 25 mg ×2) given every two weeks in adults with treatment-resistant anorexia nervosa.

This double-blind, placebo-controlled proof-of-concept trial (n=60) aims to investigate whether the antidepressant effects of psilocybin are dependent on its psychedelic effects. Participants with treatment-resistant depression (TRD) will be randomly assigned to one of three groups: 1) psilocybin 25 mg plus risperidone 1 mg; 2) psilocybin 25 mg plus placebo; and 3) placebo plus risperidone 1 mg.

Adaptive Phase IIa/IIb study (n=70) with open-label dose-finding (30/50/70 mg oral MSP-1014.OX) followed by a double-blind, randomised, placebo-controlled proof-of-concept single-dose study with preparatory and integration psychotherapy in MDD patients with partial/no SSRI response.

Phase I open-label single-group study (n=10) assessing safety, tolerability and pharmacokinetics of a single oral L-130 capsule (psilocin mucate; reported 4 mg) in healthy male volunteers under fasting conditions.

This double-blind, placebo-controlled feasibility trial (n=40) investigates Psychedelic Microdosing-Assisted Meaning-Centred Psychotherapy (PA–MCP) in advanced-stage cancer patients. Led by Dr Lisa Reynolds at The University of Auckland, the study evaluates LSD microdosing (starting at 8 µg, twice weekly for 6 weeks; 13 doses total) alongside Meaning-Centred Psychotherapy.

Open-label Phase II multi-site study (n=18) assessing three sessions of MDMA-assisted psychotherapy (80–120 mg oral MDMA with supplemental half-doses) with preparatory and integrative therapy and caregiver involvement in female participants with AN‑R or BED.

Interventional single-group study (n=8) assessing acceptability, feasibility, safety, and preliminary efficacy of Psilocybin-Assisted Psychotherapy (two 25 mg oral sessions) plus Cognitive Processing Therapy in military veterans with PTSD.

This open-label trial (n=30) aims to explore the safety and preliminary effectiveness of MDMA-assisted therapy in Israeli veterans with PTSD and moral injury from special forces undercover units.

This double-blinded, randomized, placebo-controlled, parallel-arm pilot trial (n=20) will investigate the efficacy of intravenous ketamine for emergency department treatment of suicidal ideation (SI) in adolescents.

Open-label, Phase IIa single-dose study (n=13) evaluating safety, tolerability, and pharmacodynamic effects of a single intranasal dose of BPL-003 with relapse-prevention psychological support in patients with Alcohol Use Disorder.

Randomised, double-blind, placebo-controlled Phase 2b trial (n=81) testing inhaled GH001 (5‑MeO‑DMT) individualized dosing regimen (IDR) vs placebo in patients with treatment‑resistant depression.

This randomised, double-blind, placebo-controlled Phase I trial (n=32) assesses safety, tolerability, PK and PD of single-ascending oral doses of EMP-01 (ar-MDMA) in healthy adults across four cohorts (75–225 mg).

This interventional pilot study (n=4; target n=5) tests a single oral microdose (30 mg ayahuasca alkaloids co-formulated with l‑epicatechin complex) in healthy adults aged 25–60 to assess blood neurotransmitters, IL-6, safety, and mood.

Single-group pilot interventional study (n=7) evaluating IM ketamine administered weekly for three weeks combined with brief motivational enhancement therapy for tobacco use disorder.

Randomised Phase I study (n=16) comparing PK/PD and safety of six varying doses of a fixed-combination of DMT and harmine across six study days in healthy volunteers with continuous psychological support.

Phase I, double-blind, randomised, placebo-controlled crossover in healthy volunteers (n=25) comparing inhaled DMT 60 mg with a 1 mg placebo-like inhalation across two sessions on the same day.

This observational study (n=3) aims to observe the safety and tolerability of arketamine or placebo in patients with treatment-resistant depression (TRD) over a period of 12 months following their participation in a previous clinical trial (PCN-101-21).

Open-label, single-arm Phase II multicentre study (n=6 actual) evaluating inhaled GH001 individualized dosing regimen (up to three escalating doses 6, 12, 18 mg in one day) in adults with bipolar II disorder experiencing a major depressive episode.

This crossover intervention trial (n=30) conducted by Yale University investigates whether pre-treatment with perampanel attenuates ketamine's anti-suicidal and antidepressant effects (ketamine 0.5 mg/kg IV).

This observational trial (n=100) will study the metabolic effects of esketamine (administered nasally) in patients with treatment-resistant major depressive disorder (TRD) and healthy controls, using an untargeted metabolomic approach.

This open-label trial (n=10) will examine low-dose psilocybin as a safe treatment alternative for Fragile X Syndrome (FXS), aiming to improve markers of cognition, communication, mood, behaviour, neuroinflammation, serotonin levels in exosomes, and neuroplasticity.

Prospective observational cohort (n=80) comparing acute treatment courses of IV ketamine (0.5 mg/kg infusion) versus IN esketamine (56 mg then 84 mg) in adults with treatment-resistant major depressive disorder and suicidal ideation.

Randomized crossover, Phase I healthy volunteer study (n=36) testing IV DMT boluses (5–25 mg range, with placebo) to establish dose–response for subjective and autonomic effects.

Double-blind, randomised, single-ascending-dose Phase I study (n=48) comparing single oral ascending doses of Lucid-201 (1,2,4,6 tablets by cohort) with 100 mg niacin active placebo in healthy volunteers and patients with mild-to-moderate depressive symptoms to assess safety, PK and PD.

Open-label, ascending-dose, within-subject tolerability study (n=20) of MDMA (40, 80, 120 mg) in clinically stable patients with schizophrenia to assess psychotic symptom response at 24 hours.

This Phase I trial (n=24) will investigate the safety, tolerability, and pharmacokinetics of NeuroDirect Ketamine in healthy adult volunteers.

Open-label interventional parallel study (n=96) comparing depressed patients treated with esketamine (Spravato) with healthy volunteers using fMRI emotional tasks, behavioural measures and biological profiling.

This is a single-arm, open-label Phase II clinical trial (n=15) investigating the anti-depressive effects of GH001 in postpartum depression (PPD) patients.

Adaptive, non-randomised Phase I healthy volunteer study (target n=15) testing IV psilocybin 2 mg (2‑ or 10‑minute infusions) with or without 0.2 mg oral clonidine to identify regimens that permit dosing during sleep.

Double-blind, placebo-controlled, randomised single-dose cohorts (n=64 across cohorts A–G) and an open-label multiple-dose cohort (J) investigating safety and serum pharmacokinetics of IV GH002 (5‑MeO‑DMT) in healthy volunteers.

This double-blind, placebo-controlled trial (n=40) aims to investigate the potential neurophysiological synergy effects between mindfulness meditation and psychedelics, particularly Ayahuasca, on experienced meditators.

Prospective observational study (n=120) assessing belief-updating in TRD patients before and 24 hours after a single antidepressant dose; a 60-patient subset will undergo fMRI (ketamine or monoaminergic treatments in routine care).

This treatment trial (n=40) aims to enhance depression relief among patients already undergoing esketamine treatment by introducing computer-based cognitive training.

This terminated diagnostic trial (n=1) aimed to measure the effects of ketamine infusion on cyclic AMP (cAMP) signalling in the brain using [11C]-(R)-Rolipram.

Phase III, randomised, double-blind, parallel-group study (n=568) comparing two administrations of COMP360 psilocybin at 25 mg, 10 mg and 1 mg in adults with treatment-resistant depression.

Open-label single-group study (n=12) giving four psilocybin doses (10 mg then three 25 mg sessions, ≥7 days apart) to healthy volunteers with repeated MRI to map brain and physiological correlates.

Double-blind, randomised, placebo-controlled, crossover mechanistic trial (n=52) testing single IV infusions of ketamine (0.71 mg/kg), midazolam (0.025 mg/kg), dexmedetomidine (0.025 mg/kg), or saline in non-treatment-seeking smokers.

This Phase II interventional trial (n=102) randomises adults with MDD and up to four prior treatment failures to single-dose COMP360 (25 mg, 10 mg or 1 mg) with psychological support to assess safety, tolerability, pharmacokinetics and efficacy.

Single-blind, randomised, parallel extension (withdrawn) assessing maintenance of improvement over 3 months (n=0) with intranasal esketamine (56 or 84 mg, 8 doses) plus Almond Therapy versus esketamine plus treatment as usual in participants with TRD.

This Phase II/III randomized pilot trial (n=24) conducted by The University of Texas Health Science Center at San Antonio aims to assess the feasibility of administering 100mg intramuscular (IM) ketamine alongside a Crisis Response Plan for patients with acute suicidal ideation in the Emergency Department.

Open-label, crossover study (n=14) assessing IM and IV SPL026 (DMT) in healthy participants with varying psychedelic experience (Part A crossover IM→IV; Part B single IM).

This open-label trial (n=35) will assess the electroencephalographic (EEG) responses before, during, and after four weekly low-dose (60 mg) intravenous ketamine infusions in patients with major depressive disorder (MDD).

This open-label, single-arm trial (n=30) aimed to evaluate the effect of length of time on selective serotonin reuptake inhibitors (SSRIs) on the response to psilocybin-assisted therapy in individuals with mild-moderate Major Depressive Disorder (MDD).

Observational cohort study (n=500) evaluating real-world home and clinic ketamine treatment plans for people with chronic conditions (pain, depressive and anxiety disorders) and the effect of adjunct therapies.

Double-blind, randomised, active placebo-controlled parallel study (n=126) testing two LSD doses (150 µg; second session 150 or 250 µg) versus low-dose active placebo (10 µg) for alcohol use disorder.

Open-label, randomised, parallel two-arm Phase I study (n=24) comparing 8-week MBSR vs 8-week MBSR plus a single 25 mg psilocybin-assisted group psychotherapy session for frontline healthcare providers with depression and burnout.

This neuroimaging trial (n=24) investigates the effects of one high dose of psilocybin (25mg) in those with depression. It specifically investigates the synaptic density (synapses are the connections between brain cells; neurons). The aim is to assess the relationship between the antidepressant and neurotrophic (growth within brain) effects of psilocybin.

Single-group Phase II study (n=15) testing two doses of oral psilocybin (15 mg then 25 mg, two sessions ~2 weeks apart) with preparatory and integration psychotherapy in US military Veterans with PTSD.

This double-blind, placebo-controlled crossover trial (n=60) investigates the effects of LSD on neural synchrony, prosocial behavior, and relationship quality in healthy romantic couples.

This RCT (n=24) does a direct comparison, the first one in a double-blind trial, of MDMA, psilocybin, and 2C-B (10/20/30 mg) plus placebo in a six-period crossover in healthy subjects.

This double-blind, placebo-controlled trial (n=54) will administer 5-MeO-DMT intramuscularly in varying doses (single 0.5–13 mg and multiple-dose combinations) in healthy adults to assess pharmacokinetics, safety, and tolerability.

This single-arm trial (n=15) aims to assess the safety, tolerability, and feasibility of using psilocybin (25mg) in combination with psychotherapy for methamphetamine use disorder.

Open-label Phase I study (n=24 planned; 18 enrolled) single 27.5 mg IV SPL026 (DMT fumarate) 10-minute infusion in adults with major depressive disorder, comparing patients on stable SSRI versus those not on pharmacotherapy; primary outcomes: safety, PK/PD and exploratory efficacy.

Open-label, single-group proof-of-concept study (n=15 actual) assessing simultaneous administration of oral aspirin (486 mg) + oral ketamine (80 mg) as an adjunct to oral antidepressant therapy in outpatients with treatment-resistant depression.

Randomised, double-blind, crossover neuroimaging study (n=67) comparing single doses of psilocybin 2 mg and 5 mg versus placebo in adults with and without Autism Spectrum Disorder to probe serotonin system regulation.

Single-group interventional study (n=48) assessing effects of personal psychedelic experience (MDMA, LSD, psilocybin) on therapists' therapeutic attitude and related capacities during SÄPT training.

Phase III randomised, double-blind, placebo-controlled trial (n=255) comparing a single 25 mg COMP360 psilocybin dose plus psychological support versus placebo in adults with treatment-resistant depression (Part A).

Single-arm, open-label interventional study (n=20 planned, ACTUAL registry count=5) of psilocybin-assisted interpersonal therapy for treatment-resistant major depression; two psilocybin doses plus eight psychotherapy sessions.

Early Phase I, randomized, triple-blind, placebo-controlled trial (n=250 MDD; +60 healthy controls) testing a single sub‑anesthetic IV ketamine infusion (0.5 mg/kg) versus saline to assess glutamate stress response, anhedonia, decision-making, and emotion processing.

Randomised crossover Phase I healthy volunteer study (n=8) assessing two oral DMT–harmala formulations with dose escalation (1.0→1.4 mg/kg DMT; 4→5.6 mg/kg harmala).

This study aims to investigate the effects of repeated dosing of oral psilocybin on obsessive-compulsive disorder (OCD) symptomatology in a randomized, waitlist-controlled design with blinded independent ratings, and assess psychological mechanisms that may mediate psilocybin's therapeutic effects on OCD.

This observational, naturalistic study (n=1000), conducted by the Psychedelic Data Society (with the Quantified Citizen app), is set to explore the relationship between substance use and personality profiles.

Double-blind, randomized, parallel Phase II/III RCT (n≈300 estimated) comparing a single 25 mg oral dose of psilocybin plus psychotherapy versus a single 100 mg niacin active placebo plus psychotherapy in outpatients with advanced cancer to treat anxiety, depression and existential distress.

Phase I, non-randomised, sequential 3-session psilocybin-assisted psychotherapy study (n=30) using 3+3 dose-escalation sequences (doses 15→45 mg) to evaluate safety, tolerability, and preliminary efficacy for PTSD.

Double-blind trial (n=60) testing single ascending and repeated IV DMT infusions (bolus + 6-h infusion) in healthy volunteers to assess safety and tolerability.

Single-group mechanistic feasibility study (n=19) administering up to 10 mg psilocybin (COMP360) on two occasions to people with OCD to assess cognitive inflexibility, neuroplasticity, and symptom changes.

Phase I open-label randomised two-way crossover PK study in healthy volunteers (n=14) comparing 25 mg COMP360 as a single 25 mg capsule versus five 5 mg capsules in the fed state.

This interventional trial (n=100) aims to investigate the long-term maintenance effects of ketamine and esketamine on reducing suicide risk in patients with Major Depressive Disorder (MDD) and suicidal ideation (SI).

Single-blind, randomised Phase II trial (n=6, terminated) comparing Almond Therapy plus intranasal esketamine to Treatment as Usual plus intranasal esketamine over 28 days; esketamine given twice-weekly for 8 doses (56 mg initial, then 56 or 84 mg).

Randomised, double-blind, placebo-controlled Phase II trial (n=90) testing a single 25 mg dose of psilocybin plus psychological support versus placebo in treatment-seeking adults (20–70 yrs) with alcohol use disorder.

This open-label single-group assignment trial (n=20) aims to evaluate the feasibility, tolerability, and preliminary effectiveness of MDMA-assisted therapy for adjustment disorder (AD) in 10 dyads of cancer patients and their concerned significant others (CSOs).

This observational trial (n=30) will investigate the neurocomputational model of ketamine treatment response predictions in treatment-resistant depression (TRD).

Open-label Phase I single-group study (n=8) comparing oral (25 mg) and IV (5 mg) psilocybin in healthy adults to assess bioavailability, subjective effects and safety.

This open-label trial (n=30) will test whether the MDMA-assisted psychotherapy protocol is also effective in treating PTSD incurred by healthcare workers during the Covid pandemic.

Multicenter, quadruple-blind, Phase II randomized controlled trial (n=100) comparing a single oral dose of psilocybin plus brief existential psychotherapy versus a single oral dose of ketamine plus the same psychotherapy for demoralization in patients near end of life (≤2 years expected).

Open-label Phase I interventional study (n=24 planned; registry reports 18 actual) testing single IV doses of SPL026 (DMT fumarate) in MDD patients on SSRIs versus those not on SSRIs to assess safety and tolerability.

Open-label, single-group Phase II study (n=15) of psilocybin-assisted psychotherapy for treatment-resistant depression: two 25 mg oral dosing sessions (6 weeks apart) with preparatory and integrative therapy over 12 weeks.

Open-label, randomized crossover/wait-list study (n=30) testing two psilocybin sessions (20 mg, then 30 mg if tolerated) for treatment of OCD.

This randomised, double-blind, placebo-controlled trial (n=0, withdrawn) aimed to assess the efficacy of micro-dosed psilocybin (PSIL428) in reducing anxiety and/or depression levels in adults.

Phase I open-label, single-ascending-dose study (n=27) using CRM to determine the maximum tolerated oral dose of harmine in healthy volunteers.

Single-group feasibility study (n=0, withdrawn) assessing esketamine nasal spray with clinician-directed CBT supported by the Mindset app plus oral antidepressant in participants with treatment-resistant depression.

The present study is a modern randomized cross-over trial, investigating different continuous intravenous DMT dose rates over a broad dose range.

This interventional trial (n=500) designated as Ketamine Therapy Experiential Education Study (KTEES1), sponsored by Integrative Psychiatry Institute, investigates the effects of low-dose ketamine, administered intramuscularly to clinicians within a psychedelic-assisted therapy (PAT) training programme.

Observational prospective cohort (n=140) collecting real-world safety and tolerability data on ketamine treatment (IV, intranasal, oral) in adult psychiatric inpatients with a range of diagnoses including MDD, PTSD, OCD and others.

Phase I/II study (n=62 estimated) testing two fixed psilocybin doses (10 mg then 25 mg, one month apart) combined with either 12-session PA-CBT or 6-session minimal supportive therapy in adults with major depressive disorder to assess feasibility, acceptability and preliminary efficacy.

Open-label, single-group Phase II study (n=10) assessing a single 25 mg oral dose of psilocybin for adults with MDD and co-occurring BPD to evaluate safety and efficacy.

Open-label, single-group Phase I study (n≈11) assessing safety, feasibility, and acceptability of a single 25 mg oral psilocybin dose with supportive psychotherapy and multidisciplinary palliative care in cancer survivors with demoralization and chronic pain.

This adaptive, randomised, double-blind, placebo-controlled trial (n=48) evaluated the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending intravenous doses of GM-2505 (second-gen, shorter duration, 5-HT2A agonist) in healthy volunteers.

Randomised, double-blind, placebo-controlled, parallel-group Phase II trial (n=56) testing a single subcutaneous MIJ821 injection plus standard care versus placebo in participants with treatment-resistant depression (TRD).

Single-group, open-label Phase I study (n=9 actual) assessing tolerability and efficacy of low-dose IV ketamine infusions for Levodopa-Induced Dyskinesia in Parkinson's disease.

This interventional trial (n=0, withdrawn) aimed to investigate the brain activity effects of psychedelic medicines, specifically psilocybin or MDMA, in healthy volunteers.

This open-label trial (n=20) will take EEG measures on participants who receive two doses of psilocybin (up to 25mg). Next to the brain measures, participants will be studied up to six months later.

This open-label trial (n=60) aims to assess the efficacy and safety of repeated subanesthetic maintenance doses of intravenous (IV) ketamine in patients with treatment-resistant bipolar depression (TRBD) over a period of twelve weeks.

Open-label, non-randomised feasibility study (n=30) of three weekly IM ketamine sessions (with optional small supplemental dose) combined with preparatory and integration psychotherapy for adults with treatment-resistant depression.

This observational cohort study (n=30) explored perceptions of MDMA-Assisted Therapy among veterans with PTSD.

This Phase III interventional trial (n=140) evaluates whether continuous low-dose ketamine infusion reduces morphine consumption by ≥25% at 48 hours in severe trauma patients versus placebo.

Double-blind, randomised, multi-site trial (n=66) comparing two psilocybin sessions (30 mg; second session 30 or 40 mg) versus active placebo niacin (150 mg; second session 150 or 200 mg) plus CBT for smoking cessation.

Randomised, parallel-group Phase II study (n=32 actual) comparing COMP360 psilocybin 25 mg versus 1 mg with psychological support in adults with anorexia nervosa to evaluate efficacy and safety.

Randomized, double-blind, comparator-controlled crossover trial (n=30) testing low-dose IV ketamine (0.5 mg/kg, 40 min infusion) versus midazolam in patients with OCD at the Medical University of Vienna.

Double-blind, randomised, placebo-controlled single-ascending subcutaneous dose PK and safety study in healthy volunteers (n≈48; cohorts of 8, 6 active + 2 placebo) of FT-104 HCl (psilocybin formulation).

Phase I/II, randomized, triple-blind, placebo-controlled ascending-dose IV study (Part 1, HVs) and Phase IIa open-label IV study in MDD (Part 2); single IV doses of ELE-101 (psilocybin) with PK/PD and safety assessment.

This Phase I/II randomised, double-blind, placebo-controlled trial (n=57) studied the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending oral doses of CYB003, a synthetic psilocybin analogue, in healthy participants and those with major depressive disorder (MDD).

This observational cohort study (n=100) aims to assess the efficacy of psychedelics, including psilocybin, MDMA, LSD, and ketamine, for improving measures of wellness.

Randomised, triple-masked, crossover Phase I study (n=20) comparing oral psilocin (17.5 mg), sublingual psilocin (2.18–4.36 mg), and oral psilocybin (25 mg) in healthy adults with preparatory and integration sessions.

Randomised, double-blind, placebo-controlled parallel study (n=60) comparing a single IV ketamine infusion (0.5 mg/kg) to saline in patients with treatment-resistant depression to assess effects on autobiographical memory, emotional and reward processing, and brain connectivity.

This crossover trial (n=24) investigates the acute effects of R- and S-MDMA compared to racemic MDMA and placebo in healthy subjects.

This is a Phase II, multi-centre, randomized, double-blind, parallel-group, dose-finding study to assess the effect of four doses of MM-120 (25, 50, 100 or 200 μg LSD freebase-equivalent) for the treatment of anxiety symptoms in subjects diagnosed with generalized anxiety disorder (GAD).

This double-blind, placebo-controlled trial (n=140) investigates the efficacy and safety of ketamine in rapidly reducing severe suicide risk among youth aged 14-30 who have attempted suicide.

Part 1: double-blind, randomized, placebo-controlled 4-period crossover in healthy volunteers (n=36) comparing therapeutic and supratherapeutic psilocybin, placebo, and open-label moxifloxacin; Part 2: open-label randomized 2-period crossover (n=24) assessing food effect on psilocybin pharmacokinetics.

Double-blind, placebo-controlled Phase II trial (n=160) evaluating 25 mg psilocybin plus psychotherapy versus placebo in adults with Alcohol Use Disorder (AUD) over 24 weeks.

Non-randomised, sequential Phase I inhaled DMT study (n=27) in healthy volunteers; two ascending inhaled doses given in fixed order on the same day, 2 hours apart.

This Phase I/II interventional trial (n=96) will investigate the use of intravenous ketamine for the rapid reduction of suicidality in paediatric patients presenting with suicidal ideation (SI) in the emergency department (ED).

This placebo-controlled trial (n=56) will investigate the efficacy and safety of high-dose intravenous ketamine infusion in treating Chronic Daily Headaches (CDH) syndrome.

Randomised, double-blind, placebo-controlled Phase I trial (n=38) assessing safety, tolerability, PK and PD of IV and IM SPL028 (deuterated DMT fumarate) in healthy participants; optional Part B (MDD) did not take place.

This Phase II, open-label, non-randomized, 3-cohort study assesses the feasibility and safety of MDMA-assisted group therapy for the treatment of PTSD in veterans

Phase I, randomised, placebo-controlled crossover study (n=60; 25 MDD patients, 35 healthy controls) assessing IV subanaesthetic ketamine (0.5 mg/kg) vs saline during MRI to investigate effects on aesthetic processing and role in antidepressant/anhedonia mechanisms.

This open-label fMRI study will assess the effects of a single dose of psilocybin on rumination and the neural correlates of rumination in individuals with treatment-resistant major depressive disorder.

Open-label, crossover Phase I study (target n=30, actual enrolment 14) assessing safety, blood levels and effects of SPL026 (DMT fumarate) given IM and IV in healthy psychedelic-experienced (Part A) and little/no-experience (Part B) participants.

Open-label feasibility single-group study (n=4) of MAPS manualised MDMA-assisted psychotherapy for treatment-refractory PTSD with three MDMA-assisted sessions (initial 80 mg; supplemental half-dose at 1.5–2 h; sessions 2–3 may use 80–120 mg).

Non-randomised, parallel interventional study (n=24) testing a single 25 mg oral psilocybin session with preparatory and integration counselling for distress in persons with inoperable pancreaticobiliary cancer; paired family-member observational arm.

This therapeutic exploratory trial (n=30, withdrawn), sponsored by MAPS Europe B.V., Netherlands, aimed to assess the long-term safety and persistence of effectiveness of manualized MDMA-assisted therapy for the treatment of posttraumatic stress disorder (PTSD).

This open-label pilot study (n=30) aims to examine the effect of intravenous (IV) ketamine treatment on acute suicidality (SI) in patients with bipolar depression (BD).

Open-label single-group study (n=17) assessing two oral psilocybin doses (15 mg, then 25 mg at 2 weeks) plus psychotherapy for adults with fibromyalgia.

Randomised, quadruple-blind, placebo-controlled crossover study (n=45) testing single oral high (100 µg) versus low dose LSD in healthy volunteers to assess effects on neuroplasticity.

Randomised, double-blind, parallel trial (n=120) comparing two IM ketamine sessions with psychotherapy versus a naturalistic comparator in people with terminal illness; primary outcomes are STAI‑trait and DADDS.

Randomised, triple-blind, crossover early-phase study (n=43) comparing single oral MDMA 125 mg, methamphetamine 20 mg, and placebo in healthy volunteers to assess social motivation, social ability, and neural indices of social function.

Crossover, randomised Phase I study (n=80) using single oral doses of psilocybin (range 0-14 mg) to investigate effects on visual perception and brain representations using fMRI in healthy volunteers.

This double-blind, placebo-controlled crossover trial (n=30) tests intravenous subanesthetic ketamine (TCI to 0.75 µg/ml) versus saline in patients with disorders of consciousness, with TMS-EEG and multimodal imaging assessments.

Phase II, double-blind, randomized, quadruple-masked RCT (n=72) testing four IV ketamine infusions (0.5–0.75 mg/kg over 40 minutes) versus midazolam (0.02–0.03 mg/kg) as adjunctive treatment for moderate to severe treatment-resistant bipolar depression.

This double-blind, placebo-controlled therapeutic exploratory trial (n=60; PROUD) tests a two-week adjunctive subanaesthetic ketamine regimen (0.5 mg/kg IV) to improve retention in opioid-substitution treatment and prevent relapse in patients with opioid-use disorder.

This double-blinded, placebo-controlled feasibility trial (n=32) investigates the potential of a postoperative low-dose ketamine infusion to prevent depressive symptoms in neurosurgical patients with a history of depression.

Randomized parallel-arm placebo-controlled experimental medicine study (n=60) testing a single sub-anaesthetic IV infusion of ketamine 0.5 mg/kg versus saline in people with treatment-resistant depression to assess autobiographical memory, emotional processing and decision-making.

Open-label single-group proof-of-concept study (n=20) of psilocybin-assisted treatment for PTLD with two dosing sessions (15 mg, then 15 mg or 25 mg) plus psychological support.

Single-group, Phase I study (n=12) assessing two oral psilocybin doses (25 mg; second dose 25 or 50 mg) with behavioural support for adults with methamphetamine use disorder.

Open-label, single-group Phase II study (n=22) assessing a single 25 mg oral dose of COMP360 psilocybin administered with supportive psychological conditions in participants with PTSD.

This observational trial (n=13) was conducted by the University Hospital, Strasbourg, France. The study aimed to assess the tolerance and potential synergistic effect of combining intranasal esketamine with non-selective MAOIs in patients with depression and anxiety disorders.

This observational cohort study (n=1756) aims to collect long-term outcomes from the RSI trial (NCT05277896). It was conducted by Vanderbilt University Medical Center and led by Jonathan Casey, MD, MSc.

Phase I open-label randomized, two-period crossover PK study (n=14) comparing oral MDMA 100 mg under fed versus fasted conditions in healthy volunteers to assess food effects on bioavailability and safety.

This single-group assignment trial (n=6) aims to evaluate the feasibility and preliminary efficacy of ketamine as a treatment for patients with Opioid Use Disorder (OUD) and comorbid depression (OUDCD).

Randomized, triple-blind, placebo-controlled crossover Phase II study (n=50) testing weekly 2 mg oral psilocybin microdoses versus placebo in adults with major depressive disorder.

Retrospective observational chart review (n=250) of outpatient induction-phase IV racemic ketamine for treatment-resistant major depressive disorder at a single Canadian centre.

This randomized controlled trial (n=140) investigated the impact of a single subanesthetic dose of ketamine (35mg/70kg) administered intravenously during the induction of propofol/fentanyl anesthesia on acute mood states in women undergoing fractional curettage.

Double-blind, randomised, placebo-controlled, within-subject study (n=20) testing six low/microdoses of oral psilocybin (0, 1, 2, 5, 8, 10 mg) in healthy volunteers to identify doses that improve mood, cognition and sleep without hallucinogenic effects.

This open-label feasibility study (n=21) will assess the combination of IV ketamine with Mindfulness-Based Cognitive Therapy (MBCT) for the treatment of depression.

Open-label Phase 1 parallel PK study (n=16; 8 moderate hepatic impairment, 8 matched controls) assessing single oral 80 mg MDMA to determine effects of hepatic impairment on MDMA/MDA exposure and need for dose adjustment.

Randomised, double-blind, parallel-group trial (n=12 actual) testing IV low-dose ketamine 0.5 mg/kg versus active placebo (midazolam 0.045 mg/kg) in adolescents (13–19) with treatment-resistant depression.

This open-label Phase II pilot study (n=20), registered on ANZCTR with the trial acronym MASKOT, investigates the safety and tolerability of sub-anaesthetic ketamine in young people with methamphetamine use disorder seeking treatment to reduce their methamphetamine use.

This double-blind, placebo-controlled, full cross-over trial (n=30) will study the effects of psilocybin (10mg/70kg) on brain activity and thought dynamics in healthy volunteers.

Randomised, parallel-group Phase II trial (n=80) comparing oral ketamine (1.5 mg/kg) versus active control midazolam (0.05 mg/kg) given in weeks 3 and 5 within a 6‑week group mindfulness programme for moderate–severe Alcohol Use Disorder.

Randomised, double-blind, two-period crossover Phase I study (n=24) testing whether 6-week paroxetine pretreatment reduces 5-HT2A receptor expression and subjective response to a single 0.1 mg oral LSD dose in healthy volunteers.

Randomised, double-blind, quadruple-masked, parallel-group early-phase study (n=60) testing once-weekly low-dose psilocybin (0, 1, 2.5, 5 mg) for demoralization.

Double-blind, randomised, placebo-controlled early Phase I trial (n=30) testing a single low-dose IV ketamine 0.2 mg/kg (min 10 mg, max 20 mg) versus saline in adolescents (12–18) with treatment-resistant depression and suicidal ideation in the emergency department.

Prospective observational cohort (n=80) evaluating continuous intravenous ketamine infusion (0.5 mg/kg/day) plus magnesium sulfate (1000 mg/day) over 4 days for chronic pain.

Randomised, phase IV trial (n=500) comparing four esketamine concentrations added to postoperative PCIA versus no esketamine for postpartum depression and analgesia after cesarean section.

The present study aims to investigate the effect of psilocybin on treatment-resistant PTSD

This study will investigate whether psilocybin administered under supportive conditions can reduce illicit opioid use and improve quality of life in individuals with Opioid Use Disorder (OUD) in Methadone Maintenance Treatment (MMT) who are concurrently using other opioids illicitly.

Randomised, double-blind Phase I study (n=60) evaluating single oral doses of KUR-101 versus placebo and oxycodone in healthy adults to assess safety, PK/PD, analgesic and respiratory effects.

Randomised Phase I single ascending-dose intranasal study (n=62) evaluating safety, tolerability and pharmacokinetics of BPL-003 (5‑MeO‑DMT) in healthy adults.

Randomized, open-label delayed-treatment Phase 2 study (n=20) assessing two MDMA-assisted therapy sessions (80 mg initial ±40 mg supplemental; second session may be 120 mg initial ±40 mg) plus preparatory/integrative psychotherapy for adults with generalized social anxiety disorder.

This double-blind, randomized, placebo-controlled trial (n=93) aimed to assess the safety and efficacy of IV ketamine (PCN-101) in treating Treatment-Resistant Depression (TRD).

This crossover, subject-blinded, clinical trial (n=0, withdrawn) aimed to correlate changes in brain activity with the reduction in suicidal ideation (SI) in response to a single intramuscular dose of ketamine.

Double-blind, randomised, parallel RCT (n=43) testing a single IV ketamine infusion (0.5 mg/kg over 40 min) with brief mindfulness training versus academic exercises in adults with unipolar depression.

Randomised, double-blind, placebo-controlled Phase II trial (n=180 planned) assessing once-daily KET01 prolonged-release ketamine tablets (120 mg or 240 mg) versus placebo as add-on therapy in outpatients with treatment-resistant depression.

This study aims to explore the safety and tolerability of a single dose of psilocybin (25mg) administered under supportive conditions to adult participants with TRD and chronic suicidal ideation.

Phase II randomised, quadruple-blind trial (n=12 actual) comparing four IV ketamine infusions (0.5 mg/kg each over 40 minutes across two weeks) versus midazolam in adolescents (13–17) with TRD and recent suicide event to assess reduction in suicidal ideation.

This interventional, randomised pilot feasibility study (n=44, age 18-65) aims to assess the potential of single-dose interventions (including ketamine) in reducing re-admissions for hospitalised patients with severe alcohol use disorder (AUD).