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Home/Research/Placebo/Alcohol Use Disorder (AUD)

Placebo for Alcohol Use Disorder (AUD)

4 papers and 26 clinical trials exploring placebo as a treatment for alcohol use disorder (aud).

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
IndicationOver 100 million cases worldwide, making AUD the most common substance use disorder.

Alcohol Use Disorder (AUD)

Alcohol Use Disorder (AUD) is a prevalent condition characterised by an inability to control alcohol consumption despite adverse consequences. Emerging research indicates that psychedelics may offer promising therapeutic avenues for treating AUD, with various compounds showing potential in clinical trials.

Full Alcohol Use Disorder (AUD) profile

Academic Research

4 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-assisted therapy for relapse prevention in alcohol use disorder: a phase 2 randomized clinical trial

This double-blind randomised clinical trial (n=37) found that a single dose of psilocybin (25mg) with brief psychotherapy did not significantly reduce alcohol relapse rates or consumption compared to placebo in patients with alcohol use disorder (AUD) at 4-week or 6-month follow-up, though psilocybin participants reported additional reductions in craving and temptation to drink, suggesting larger trials are needed to evaluate this approach for severely affected patients.

Published
April 1, 2025
Journal
EClinicalMedicine
Authors
Rieser, N. M., Bitar, R., Halm, S., Rossgoderer, C., Gubser, L. P., Thévenaz, M., Kreis, Y., Von Rotz, R., Nordt, C., Visentini, M., Moujaes, F., Engeli, E. J. E., Ort, A., Seifritz, E., Vollenweider, F. X., Herdener, M., Preller, K. H.
Paywallmeta

The impact of psychedelics on patients with alcohol use disorder: a systematic review with meta-analysis

This systematic review and meta-analysis (s=6; 2023) assessed the role of psychedelics in treating alcoholism (AUD). LSD and any psychedelic therapy showed enhanced odds of achieving abstinence or reducing alcohol consumption in randomised, double-blind, placebo-controlled trials. However, the study highlights methodological weaknesses in the literature. It suggests that while promising, definitive statements about the value of psychedelics in treating AUD are precluded, emphasizing the need for future trials with greater rigour.

Published
December 18, 2023
Journal
Current Medical Research and Opinion
Authors
Sicignano, D., Hernandez, A. V., Schiff, B., Elmahy, N., White, C. M.
Open Accessindividual

The Effects of MDMA-Assisted Therapy on Alcohol and Substance Use in a Phase 3 Trial for Treatment of Severe PTSD

This trial (n=90) assessed patterns of alcohol and substance use in patients receiving MDMA-assisted therapy. MDMA was associated with a significant reduction in Alcohol Use Disorder Identification Test (AUDIT) scores when compared to placebo. Changes in Drug Use Disorder Identification Test (DUDIT) scores did not significantly differ between groups.

Published
February 8, 2022
Journal
Drug and Alcohol Dependence
Authors
Nicholas, C. R., Wang, J. B., Coker, A., Mitchell, J., Klaire, S. S., Yazar-Klosinski, B., Emerson, A., Brown, R., Doblin, R.

Clinical Trials

26 trials
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

Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD

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).

Started
July 1, 2024
Type
interventional
Blinding
double
Randomized
Yes
Registry ID
NCT06349083
RecruitingPhase I

The Potential Therapeutic Effects of Psychedelic, N, N-dimethyltryptamine (DMT), on Alcohol Use Disorder (AUD)

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).

Started
March 17, 2024
Type
interventional
Blinding
double
Randomized
Yes
Registry ID
NCT06070649
Not yet recruitingPhase I/II

Ketamine for Combined Depression and Alcohol Use Disorder (KeDA)

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.

Started
January 1, 2024
Type
interventional
Blinding
triple
Randomized
Yes
Registry ID
NCT06090422

Explore further

Search all Placebo papers Search all Alcohol Use Disorder (AUD) trials Full Placebo profile Full Alcohol Use Disorder (AUD) profile