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Home/Research/MDMA/Safety & Risk Management

MDMA for Safety & Risk Management

53 papers and 15 clinical trials exploring mdma as a treatment for safety & risk management.

Compoundempathogen

MDMA

MDMA is a synthetic empathogen that enhances monoamine release, producing prosocial and anxiolytic effects without frank hallucinosis. Two Phase III trials demonstrated significant PTSD symptom reductions, though FDA review raised concerns about blinding, durability, and safety characterisation.

Full MDMA profile
IndicationMental health disorders affect over 900 million people worldwide, with conditions like PTSD and depression being among the most prevalent.

Safety & Risk Management

Safety and risk management in psychedelic therapy remains a critical area of research, necessitating vigilant assessment of potential adverse effects as clinical usage expands. Current efforts focus on ensuring that therapeutic practices minimise harm while maximising efficacy for a range of conditions.

Full Safety & Risk Management profile

Academic Research

53 papers
Open Accessmeta

Subjective and neurocognitive profiling of clinical doses of 3,4-methylenedioxymethamphetamine (MDMA) in healthy volunteers: implications for therapeutic use

This narrative review (2026) examines placebo-controlled single-dose studies of MDMA (75 to 125 mg) in healthy volunteers and finds that it acutely increases mood, empathy, trust and prosocial feelings, while causing temporary memory impairment and modest declines in motor coordination and cognitive flexibility. It also notes that post-acute fatigue and low mood can occur, and that MDMA may complicate trial blinding and expectancy in psychotherapy studies.

Published
April 8, 2026
Journal
Molecular Psychiatry
Authors
Ramaekers, J. G., Kuypers, K. P. C., Vollenweider, F. X.
Open Accessmeta

Psychedelic medicine: mechanisms, evidence, and translation to practice

This review (2026) summarises the rapidly growing evidence for psychedelic-assisted therapies, finding the strongest support for psilocybin in treatment-resistant depression (TRD) and MDMA in post-traumatic stress disorder (PTSD). It also highlights that while these treatments are generally well tolerated in controlled settings, major challenges remain around unclear mechanisms, trial limitations, scalability, and translation into routine practice.

Published
February 23, 2026
Journal
BMJ
Authors
Jacobs, E., Zahid, Z., Hinkle, J., Nayak, S., Yaden, D. B.
Open Accessindividual

Efficacy and Safety of the Neuroplastogen TSND-201 for the Treatment of PTSD A Randomized Clinical Trial

In a multicentre, double‑blind, placebo‑controlled phase 2 trial of 65 adults with chronic PTSD, once‑weekly oral TSND‑201 produced significantly greater reductions in clinician‑rated PTSD severity (CAPS‑5; LS mean difference 9.64, P = .01) and improvements in self‑reported symptoms, functioning and depression versus placebo. TSND‑201 was generally well tolerated — common adverse events included headache, decreased appetite, nausea, dizziness and transient blood‑pressure increases — supporting its potential as a rapid‑acting, durable treatment for PTSD.

Published
February 18, 2026
Journal
JAMA Psychiatry
Authors
Jones, A., Warner-Schmidt, J., Kwak, H., Stogniew, M., Mandell, B., Ching, T. H., Stein, M. B., Kelmendi, B.
Open Accessindividual

Naturalistic psychedelic use and changes in depressive symptoms

This longitudinal observational study (n=12,345) of U.S. residents found that naturalistic psychedelic use (n=505, 4.1% of participants) was associated with modest increases in depressive symptoms, particularly when occurring in 'risk contexts' characterised by negative mindset and lack of psychological support, with challenging psychedelic experiences mediating this relationship and suggesting that unsupervised psychedelic use may not be generally therapeutic and could worsen depression under certain circumstances.

Published
December 1, 2025
Journal
Journal of Affective Disorders
Authors
Simonsson, O., Hendricks, P. S., Swords, C. M., Osika, W., Goldberg, S. B.
Open Accessindividual

Psilocybin with psychotherapeutic support for treatment-resistant depression: a pilot clinical trial

An open‑label pilot trial of two 25 mg psilocybin sessions with preparatory and integration psychotherapy for treatment‑resistant depression produced a clinically meaningful reduction in self‑rated depressive symptoms at three weeks (Hedges’ g = −1.27) that was maintained at 20 weeks, although individual responses varied (two sustained responders, three relapses, two non‑responders). Exploratory analyses linked pre‑dosing mindset, spiritual experiences and perceptual shifts to outcome trajectories, with adverse events consistent with prior studies and no serious adverse events.

Published
October 2, 2025
Journal
Therapeutic Advances in Psychopharmacology
Authors
Meikle, S., Carter, O., Liknaitzky, P., Johansen, L., Iyer, R., Strauss, N., Williams, M., Castle, D., Rossell, S. L., Ids, O.
Paywallindividual

Psilocybin in alcohol use disorder and comorbid depressive symptoms: Results from a feasibility randomized clinical trial

In this double‑blind, randomised pilot trial of recently detoxified patients with severe alcohol use disorder and comorbid depression, two 25 mg psilocybin‑assisted psychotherapy sessions (versus 1 mg control) were feasible, acceptable and safe. At 12 weeks the 25 mg group showed higher abstinence (55% vs 11%) and significant reductions in percent drinking days and craving frequency, although blinding was imperfect and the study was small and preliminary.

Published
July 24, 2025
Journal
Addiction
Authors
Luquiens, A., Belahda, D., Graux, C., Igounenc, N., Serrand, C., Rochefort, P., Mura, T., Sergent, F.

Clinical Trials

15 trials
CompletedPhase II

A Study to Assess the Use of Methylone in the Treatment of PTSD (IMPACT-1)

This Phase II, two-part, multicentre trial (n=64) will assess methylone as a treatment for adults with post-traumatic stress disorder (PTSD). It is designed to evaluate the drug’s safety, tolerability, and efficacy in participants aged 18–65 years in the UK, including people who have previously tried at least one PTSD treatment without sufficient benefit.

Type
interventional
Blinding
double
Randomized
Yes
Not yet recruitingPhase III

PAPAYA: Pharmacologically-Assisted Psychotherapy for social Anxiety in Young people with Autism

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.

Started
January 15, 2025
Type
interventional
Blinding
single
Randomized
Yes
Registry ID
ACTRN12624001474549p
Not yet recruitingPhase II

Pilot investigation of psychedelic-assisted psychotherapy for treatment of post-traumatic stress disorder (PTSD) in people diagnosed with co-occurring borderline personality disorder – a controlled before-and-after study

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.

Started
July 26, 2024
Type
interventional
Blinding
none
Randomized
No
Registry ID
ACTRN12624000871549
RecruitingPhase II/III

A study of the psychological, cognitive and physiological effects of Psychedelic Medicines (ASSESS)

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.

Started
September 26, 2023
Type
interventional
Blinding
none
Randomized
No
Registry ID
ACTRN12622001535763
RecruitingPhase II

A study to investigate the safety and feasibility of delivering MDMA-assisted psychotherapy to patients with posttraumatic stress disorder

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.

Started
July 6, 2023
Type
interventional
Blinding
none
Randomized
No
Registry ID
ACTRN12623000838617
WithdrawnPhase II

A Multi-Site Study of MDMA-Assisted Psychotherapy for Eating Disorders

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.

Started
June 1, 2023
Type
interventional
Blinding
none
Randomized
No
Registry ID
NCT04454684

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