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Psilocybin-assisted therapy for severe alcohol use disorder: protocol for a double-blind, randomized, placebo-controlled, 7-month parallel-group phase II superiority trial.

Laetitia Vanderijst, Felix Hever, Anne Buot, Charles Dauré, Janaïna Benoit, Catherine Hanak, Johannes Veeser, Margot Morgiève, Salvatore Campanella, Charles Kornreich, Luc Mallet, Christophe Leys, Xavier Noël

BMC Psychiatry January 26, 2024 DOI: 10.1186/s12888-024-05502-y (opens in new tab)

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Study at a glance

AI-extracted from the abstract
Characteristics Randomized controlled trial Placebo-controlled Double-blind Peer reviewed
Sample size 62
Population Adults aged 21-64 with severe alcohol use disorder undergoing inpatient rehabilitation
Intervention Psilocybin-assisted therapy
Dose 30 mg for experimental group, 5 mg for active placebo group
Duration 4-week inpatient rehabilitation with follow-up up to six months posthospital discharge
Topics Psychedelic-assisted therapy Addiction Psilocybin
Keywords Psilocybin-assisted therapy Serotonergic psychedelics Clinical trials Addiction treatment Substance use disorders Mental health research
Citations 11
Registration NCT06160232
Key findings The study will evaluate feasibility and preliminary efficacy of psilocybin-assisted therapy as an auxiliary intervention during inpatient rehabilitation for severe alcohol use disorder.

Abstract

A significant number of individuals with alcohol use disorder remain unresponsive to currently available treatments, which calls for the development of new alternatives. In parallel, psilocybin-assisted therapy for alcohol use disorder has recently yielded promising preliminary results. Building on extant findings, the proposed study is set to evaluate the feasibility and preliminary clinical efficacy of psilocybin-assisted therapy when incorporated as an auxiliary intervention during inpatient rehabilitation for severe alcohol use disorder. Moreover, it intends to pinpoint the modifications in the two core neurocognitive systems underscored by dual-process models of addiction. In this double-blind, randomized, placebo-controlled, 7-month parallel-group phase II superiority trial, 62 participants aged 21-64 years will be enrolled to undergo psilocybin-assisted therapy as part of a 4-week inpatient rehabilitation for severe alcohol use disorder. The experimental group will receive a high dose of psilocybin (30 mg), whereas the control group will receive an active placebo dose of psilocybin (5 mg), both within the context of a brief standardized psychotherapeutic intervention drawing from key elements of acceptance and commitment therapy. The primary clinical outcome is the between-group difference regarding the change in percentage of heavy drinking days from baseline to four weeks posthospital discharge, while safety and feasibility metrics will also be reported as primary outcomes. Key secondary assessments include between-group differences in terms of changes in (1) drinking behavior parameters up to six months posthospital discharge, (2) symptoms of depression, anxiety, trauma, and global functioning, (3) neuroplasticity and key neurocognitive mechanisms associated with addiction, and (4) psychological processes and alcohol-related parameters. The discussion outlines issues that might arise from our design. EudraCT 2022-002369-14 and NCT06160232.

Comparable studies

Other randomized controlled trials on psilocybin for addiction, most cited first.

Study Year Design Participants
Percentage of Heavy Drinking Days Following Psilocybin-Assisted Psychotherapy vs Placebo in the Treatment of Adult Patients With Alcohol Use Disorder Adults aged 25–65 with DSM-IV alcohol dependence and at least 4 heavy drinking days in... 2022 Randomized controlled trial n = 95
Clinical Interpretations of Patient Experience in a Trial of Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder Participants in an ongoing trial of psilocybin-assisted treatment for alcohol use disorder 2018 Double-blind placebo-controlled clinical trial n = 3
Psilocybin-assisted therapy for relapse prevention in alcohol use disorder: a phase 2 randomized clinical trial Patients with alcohol use disorder 2025 Randomized controlled trial
Psilocybin-induced changes in neural reactivity to alcohol and emotional cues in patients with alcohol use disorder: an fMRI pilot study Adult patients with alcohol use disorder 2024 Pilot study; randomized, double-blind, placebo-controlled clinical trial n = 11
Psilocybin for alcohol use disorder: Rationale and design considerations for a randomized controlled trial. Alcohol-dependent volunteers 2022 Randomized controlled trial n = 96

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