Evidence map›Paper›PMID 38279085›Full record

ArticleBMC psychiatry2024

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 and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC psychiatry, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06160232 (Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
4.5field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06160232 phase2recruitingnot on this map

Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder: Feasibility, Clinical Efficacy & (Neuro)Cognitive Mechanisms

TypeinterventionalSponsorBrugmann University HospitalRan2024 to 2026Enrolled62ConditionsSevere Alcohol Use DisorderArmsPsilocybin (high dose), Active placebo (low dose of psilocybin)
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 7 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. The Emergence of Psilocybin in Psychiatry and Neuroscience.Pharmaceuticals (Basel, Switzerland) · 2025
    Review
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 5 institutions in 3 countries.

Laetitia VanderijstLaboratory of Medical Psychology and Addictology, Faculty of Medicine, Université libre de Bruxelles, Brussels, Belgium. laetitia.vanderijst@ulb.be.
Felix HeverLaboratory of Medical Psychology and Addictology, Faculty of Medicine, Université libre de Bruxelles, Brussels, Belgium.
Anne BuotSorbonne Université, Institut du Cerveau - Paris Brain Institute - ICM, CNRS, Inserm, Paris, France.
Charles DauréUniversité de Paris, INSERM UMRS1144, 4 avenue de l'Observatoire, 75006, Paris, France.
Janaïna BenoitPsychiatric Institute, University Hospital Brugmann, Brussels, Belgium.
Catherine HanakPsychiatric Institute, University Hospital Brugmann, Brussels, Belgium.
Johannes VeeserPsychiatric Institute, University Hospital Brugmann, Brussels, Belgium.
Margot MorgièveUniversité Paris Cité, CNRS, Inserm, Cermes3, F-75006, Paris, France.
Salvatore CampanellaLaboratory of Medical Psychology and Addictology, Faculty of Medicine, Université libre de Bruxelles, Brussels, Belgium.
Charles KornreichLaboratory of Medical Psychology and Addictology, Faculty of Medicine, Université libre de Bruxelles, Brussels, Belgium.
Luc MalletSorbonne Université, Institut du Cerveau - Paris Brain Institute - ICM, CNRS, Inserm, Paris, France.
Christophe LeysResearch Center for the Promotion of Health, Prosocial Behavior and Wellbeing, Faculty of Psychology, Université libre de Bruxelles, Brussels, Belgium.
Xavier NoëlLaboratory of Medical Psychology and Addictology, Faculty of Medicine, Université libre de Bruxelles, Brussels, Belgium.
Université Libre de Bruxelles · BECentre Hospitalier Universitaire Brugmann · BEUniversité Paris Cité · FRInserm · FRSorbonne Université · FR

Funding

Brugmann Foundation 2022-10Fonds De La Recherche Scientifique - FNRS 40010687Fonds Iris-Recherche 2023-J1820690-232470
6 · The paper itself

Abstract

backgroundA 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.

methodsIn 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. DISCUSSION: The discussion outlines issues that might arise from our design.

trial registrationEudraCT 2022-002369-14 and NCT06160232.

Indexed as

Acceptance and Commitment TherapyAlcoholismAlcohol DrinkingClinical Trials, Phase II as TopicDouble-Blind MethodEquivalence Trials as TopicHumansPsilocybinRandomized Controlled Trials as TopicTreatment OutcomePsilocybinClinical trialPsilocybin-assisted therapySerotonergic psychedelicsSevere alcohol use disorder

Identifiers

PMID38279085
PMCPMC10821548
OpenAlexW4391256257

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.