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Psilocybin-assisted therapy for reducing alcohol intake in patients with alcohol use disorder: protocol for a randomised, double-blinded, placebo-controlled 12-week clinical trial (The QUANTUM Trip Trial)

Mathias Ebbesen Jensen, Dea Siggaard Stenbæk, Tobias Søgaard Juul, Patrick MacDonald Fisher, Claus Thorn Ekstrøm, Gitte Moos Knudsen, Anders Fink‐jensen

BMJ Open October 1, 2022 DOI: 10.1136/bmjopen-2022-066019 (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 90
Population Treatment-seeking adults aged 20–70 with alcohol use disorder
Interventions Psilocybin-assisted therapy Placebo
Duration 12-week intervention with follow-up at 1, 4, 8, and 12 weeks postdosing
Topics Psychedelic-assisted therapy Addiction Psilocybin
Keywords Clinical trials Substance misuse Addiction treatment Clinical research Substance use disorders Psychiatric medicine
Citations 21
Registration NCT05416229
Key findings The trial aims to determine whether a single psilocybin administration with psychological support reduces heavy drinking days compared to placebo in patients with alcohol use disorder.

Abstract

Introduction Alcohol use disorder is a difficult-to-treat psychiatric disorder and a major burden on public health. Existing treatment efficacy is moderate, and relapse rates are high. Preliminary findings suggest that psilocybin, a psychedelic compound, can safely and reliably occasion highly meaningful experiences that may spur a positive change in drinking behaviour when administered in a therapeutic context. However, the efficacy of a single psilocybin administration and its potential neurobiological underpinnings still remain unknown. Methods and analysis To establish efficacy, we will investigate the effects of psilocybin-assisted therapy versus placebo in a randomised, double-blinded, placebo-controlled 12-week clinical trial. Ninety treatment-seeking patients, aged 20–70 years, diagnosed with alcohol use disorder will be recruited from the community via advertisement and referrals from general practitioners or specialised treatment units. The psilocybin or placebo will be administered in accordance with a protocol for psychological support before, during and after the dosing. Outcome assessments will be carried out 1, 4, 8 and 12 weeks postdosing. The primary outcome is reduction in the percentage of heavy drinking days from baseline to follow-up at 12 weeks. Key secondary outcomes are as follows: (1) total alcohol consumption, (2) phosphatidyl-ethanol, an objective biomarker for alcohol, (3) plasma psilocin, the active metabolite, to establish a possible therapeutic range, (4) the acute subjective drug experience as a possible predictor of treatment outcome and (5) neuronal response to alcohol cues and cognitive flexibility within corticostriatal pathways by use of functional MR brain imaging 1-week postdosing. Ethics and dissemination Ethical approval has been obtained from the Committee on Health Research Ethics of the Capital Region of Denmark (H-20043832). All patients will be provided oral and written information about the trial before screening. The study results will be disseminated by peer-review publications and conference presentations. Trial registration number EudraCT 2020-000829-55 and NCT05416229 .

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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