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Home/Research/Placebo/Substance Use Disorders (SUD)

Placebo for Substance Use Disorders (SUD)

13 papers and 51 clinical trials exploring placebo as a treatment for substance use disorders (sud).

CompoundComparator / Control

Placebo

Placebo is the most widely referenced comparator in psychedelic clinical research, appearing in over 500 trials. Understanding how placebos are designed, administered, and interpreted is essential to evaluating the evidence base for psychedelic-assisted therapies — and one of the field’s most contested methodological challenges.

Full Placebo profile
IndicationAmong the world’s largest preventable health burdens

Substance Use Disorders (SUD)

Addiction is one of the oldest hopes for psychedelic medicine, going back to LSD trials for alcoholism in the 1950s. Today psilocybin is the workhorse, with positive trials in alcohol, tobacco and cocaine use disorders, and the cross-substance signal is real. But the picture is mixed rather than settled: a major alcohol trial was null, the studies are small, and almost all of them struggle to keep patients unaware of whether they got the drug. This page is the hub; alcohol, opioid and tobacco use disorders have their own dedicated pages.

Full Substance Use Disorders (SUD) profile

Academic Research

13 papers
Open Accessindividual

Epigenome-wide association study of psilocybin-induced methylome changes in alcohol use disorder

This longitudinal randomised study (n=37) in detoxified patients with alcohol use disorder examined DNA methylation changes after psilocybin 25 mg versus placebo and found one psilocybin-linked methylation site, plus broader changes related to depression and drinking measures. The changes involved genes and pathways linked to neuroplasticity and immune function.

Published
May 26, 2026
Journal
Translational Psychiatry
Authors
Urban, M. M., Zillich, L., Rieser, N. M., Herdener, M., Spanagel, R., Vollenweider, F. X., Preller, K. H., Meinhardt, M. W.
Open Accessindividual

Psilocybin in the Treatment of Cocaine Use Disorder A Randomized Clinical Trial

This randomised quadruple-blind placebo-controlled clinical trial (n=40) found that a single 25 mg/70 kg dose of psilocybin, given with psychotherapy, increased cocaine-free days and delayed relapse compared with diphenhydramine in people with cocaine use disorder.

Published
May 7, 2026
Journal
JAMA Network Open
Authors
Hendricks, P. S., Lappan, S. N., Shelton, R. C., Lahti, A. C., Cropsey, K. L., Johnson, M. W., Bradley, M., Simonsson, O., Davis, L. L., Grossman, D. H., Ortiz, C. E.
Open Accessindividual

Effects of a Single Sub-Anesthetic Dose of Ketamine in Tobacco Use Disorder: An Active-Placebo, Randomized Crossover Study

This randomised crossover study (n=18) tested a single sub-anesthetic ketamine infusion against midazolam in adults with tobacco use disorder who were not trying to quit smoking. Ketamine was well tolerated but did not clearly reduce smoking, craving or withdrawal, although some participants reported stronger psychological effects and found abstaining easier afterwards.

Published
April 30, 2026
Journal
Brain Sciences
Authors
Luzum, N. R., McCall, M. H., Talley Boyd, C., Columbano, H., Ip, E., Saldana, S., Oliveto, A. H., Addicott, M.
Paywallindividual

Single Treatment With MM120 (Lysergide) in Generalized Anxiety Disorder: A Randomized Clinical Trial

In a multicentre phase 2b randomised placebo‑controlled trial of 198 adults with moderate to severe GAD, a single dose of MM120 (lysergide D‑tartrate) produced a dose‑dependent reduction in HAM‑A scores at 4 weeks, with 100 µg and 200 µg showing significant improvements versus placebo (least‑squares mean differences −5.0 and −6.0 points, respectively). Adverse events were dose‑related—most commonly visual perceptual changes and nausea—supporting the efficacy and informing dose selection for phase 3 trials.

Published
October 21, 2025
Journal
JAMA
Authors
Robison, R., Barrow, R., Conant, C., Foster, E., Freedman, J. M., Jacobsen, P. L., Karas, S. M., Karlin, D. R., Solomon, T. M., Wernli, M. H., Fava, M. F., Jemisen, J.
Paywallindividual

The effect of methamphetamine and 3,4-methylenedioxymethamphetamine on peripheral endocannabinoid concentrations: a study in healthy adults

This within-subject, double-blind study (n=22) found that acute administration of methamphetamine (14 mg/70 kg) significantly lowered plasma 2-arachidonoylglycerol concentrations compared to placebo at 150-180 minutes post-administration, whilst MDMA (100 mg) did not affect endocannabinoid levels, and higher anandamide concentrations during the placebo condition correlated with disliking the 'drug effects'.

Published
October 6, 2025
Journal
Psychopharmacology
Authors
Mayo, L. M., Haggarty, C. J., Petrie, S. R., Hill, M. N., Bershad, A. K., de Wit, H., Deutch, A. Y.
Open Accessindividual

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous RE104: A Double-Blind, Randomized, Single Ascending Dose Placebo-Controlled Study

This double-blind, randomised, placebo-controlled Phase I study (n=48) evaluates the safety, pharmacokinetics, and psychoactive effects of RE104 (psilocybin analog; Luvesilocin; a prodrug of 4-OH-DiPT) in healthy adults with prior psychedelic experience. RE104 was well tolerated up to 40 mg with no serious adverse events, and plasma levels of its active form correlated with subjective drug effect and mystical experience scores. The compound produced psilocybin-like effects with a shorter duration (3-4 hours), supporting further therapeutic investigation.

Published
July 21, 2025
Journal
Journal of Clinical Psychopharmacology
Authors
Ludbrook, G., Bryson, N., Taylor, B., Hocevar-Trnka, J., Johnson, M. W., Hirman, J., Morrish, G., Alexander, R., Pollack, M.

Clinical Trials

51 trials
Not yet recruitingPhase II

Targeting Treatment-Resistant OUD With Ketamine-Assisted Mindfulness Oriented Recovery Enhancement

This Phase II, randomised, double-blind trial (n=88) will evaluate the efficacy of Mindfulness-Oriented Recovery Enhancement combined with Ketamine-Assisted Psychotherapy (KetaMORE) for individuals with opioid use disorder (OUD) receiving medication treatment. The primary aim is to determine whether participants receiving the KetaMORE intervention will show greater reductions in opioid use and craving compared to those receiving ketamine-assisted psychotherapy paired with a non-mindfulness support group. Participants will be randomly assigned to one of two conditions: the experimental group will receive ketamine-assisted psychotherapy alongside Mindfulness-Oriented Recovery Enhancement, while the control group will receive ketamine-assisted psychotherapy with a support group intervention that does not include mindfulness training. Both groups will undergo identical ketamine dosing and psychotherapy sessions, differing only in the adjunctive behavioural intervention. Key outcome measures will include the number of days of opioid use, time to first opioid use lapse, craving levels, and mood, assessed through ecological momentary assessments and standardised measures at various points throughout the study. The trial is set to begin in February 2026 and aims for completion by April 2028.

Started
February 1, 2026
Type
interventional
Blinding
double
Randomized
Yes
Registry ID
NCT07369089
RecruitingPhase II

Ketamine for Opioid Use Disorder

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.

Started
August 1, 2025
Type
interventional
Blinding
quadruple
Randomized
Yes
Registry ID
NCT06943859
RecruitingPhase II

Ketamine and Neurofeedback as Combined Therapeutic Interventions to Target Glutamatergic Neurotransmission in Alcohol Use Disorder (Nektar)

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.

Started
May 1, 2025
Type
interventional
Blinding
triple
Randomized
Yes
Registry ID
NCT06969937
RecruitingPhase II

Psilocybin with Psychological Support (Psi-PS) for Military Veterans and First Responders with Co-occurring PTSD & Alcohol Use Disorder (AUD) (Psi-PS)

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).

Started
March 1, 2025
Type
interventional
Blinding
double
Randomized
Yes
Registry ID
NCT06853912
Not yet recruitingPhase II

Psilocybin-assisted Therapy for Alcohol Use Disorder

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.

Started
September 1, 2024
Type
interventional
Blinding
double
Randomized
Yes
Registry ID
NCT06444243
RecruitingPhase II

Ketamine for Methamphetamine Use Disorder (KMD)

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).

Started
August 1, 2024
Type
interventional
Blinding
triple
Randomized
Yes
Registry ID
NCT06496750

Explore further

Search all Placebo papers Search all Substance Use Disorders (SUD) trials Full Placebo profile Full Substance Use Disorders (SUD) profile