Psilocybin-assisted therapy for alcohol use disorder: A systematic review of randomized controlled trials
Kirolos Eskandar, Kerolos Shahat
Pharmacotherapy in Psychiatry and Neurology November 6, 2026 DOI: 10.17219/fpn/242405 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Systematic review Randomized Peer reviewed |
|---|---|
| Sample size | 165 |
| Population | Adults with alcohol use disorder |
| Intervention | Psilocybin-assisted therapy |
| Topics | Addiction Psilocybin |
| Key findings | The authors conclude that current evidence does not establish the efficacy of psilocybin-assisted therapy for alcohol use disorder or demonstrate relapse-prevention benefits. Across three randomized trials, one reported significantly fewer heavy-drinking days than active placebo, one found no significant differences in consumption, abstinence, or relapse at 4 weeks or 6 months, and a small feasibility trial reported higher 12-week abstinence with 25 mg than 1 mg psilocybin, a result sensitive to missing-data assumptions. All outcomes were judged at high risk of bias, with low to very low certainty. |
Abstract
To critically synthesize randomized controlled evidence on the efficacy, relapse prevention, durability, and safety of psilocybin-assisted therapy in adults with alcohol use disorder (AUD), distinguishing alcohol-consumption reduction, abstinence, and relapse outcomes.PubMed, Scopus, Web of Science, and the Cochrane Library were searched without date or language restrictions.Three randomized controlled trials involving 165 participants met the eligibility criteria.Owing to clinical and methodological heterogeneity, findings were synthesized narratively without meta-analysis.One trial reported significantly fewer heavy-drinking days with psilocybin than with active placebo.A second found no significant differences in alcohol consumption, abstinence, or relapse at 4 weeks or 6 months.A small feasibility trial reported higher 12-week abstinence with 25-mg than with 1-mg psilocybin; however, this result was based on few participants and was sensitive to missing-data assumptions.Improvements in craving and selected psychiatric outcomes were also reported, but durable benefits remained uncertain.Adverse effects were generally transient, and no deaths were reported.All assessed outcomes were judged at high overall risk of bias, particularly because of functional unblinding affecting self-reported outcomes.Certainty was low for heavy-drinking days and very low for other outcomes.Current evidence does not establish the efficacy of psilocybin-assisted therapy for AUD or demonstrate relapse-prevention benefits.Larger randomized trials with credible controls, standardized therapeutic protocols, objective alcohol-use measures, and longer follow-up are warranted.
Comparable studies
Other systematic reviews and meta-analyses on psilocybin for addiction, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Therapeutic effect of psilocybin in addiction: A systematic review Patients with alcohol use disorder or tobacco use disorder | 2023 | Systematic review | n = 151 |
| Psilocybin-Assisted Therapy: A Review of a Novel Treatment for Psychiatric Disorders Patients with psychiatric disorders related to anxiety, depression, and substance use | 2017 | Systematic review | n = 7 |
| The intensity of the psychedelic experience is reliably associated with clinical improvements: A systematic review and meta-analysis. Patients treated with classical psychedelics | 2025 | Meta-analysis | |
| Psychedelic‐assisted treatment for substance use disorder: A narrative systematic review Participants in studies of psychedelic-assisted treatment for alcohol, tobacco, and... | 2025 | Systematic review | n = 2,035 |
| Psychedelic Treatments for Substance Use Disorder and Substance Misuse: A Mixed Methods Systematic Review Adults with substance use disorder or substance misuse | 2023 | Systematic review |
Citations in the library
Cites 11
- Percentage of Heavy Drinking Days Following Psilocybin-Assisted Psychotherapy vs Placebo in the Treatment of Adult Patients With Alcohol Use Disorder JAMA Psychiatry August 24, 2022
- Blinding and expectancy confounds in psychedelic randomized controlled trials Expert Review of Clinical Pharmacology May 26, 2021
- Me, myself, bye: regional alterations in glutamate and the experience of ego dissolution with psilocybin. Neuropsychopharmacology November 1, 2020
- Therapeutic effect of psilocybin in addiction: A systematic review Frontiers in Psychiatry February 9, 2023
- Psilocybin-assisted therapy for relapse prevention in alcohol use disorder: a phase 2 randomized clinical trial EClinicalMedicine March 14, 2025
and 6 more in the library