Psilocybin-assisted Therapy for Treatment of Alcohol Use Disorder

NCT05416229 | Completed Phase 2

• 1 other identifier: PSILO4ALCO-TRIAL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Note: The trial is only eligible for citizens of Denmark. The purpose of this project is to assess the treatment efficacy of a single high dose of psilocybin administered within a protocol of psychological support to patients diagnosed with alcohol use disorder (AUD).

Conditions

Alcohol Use Disorder

Keywords

psilocybin; alcohol dependence; addiction; randomized controlled trial; brain imaging

Outcome Measures

Primary Outcomes (1)

• Change in percentage of heavy drinking days

  Heavy drinking is defined as days with five drinks/60 grams of alcohol or more for men, four drinks/48 grams of alcohol or more for women. Data will be collected using the Timeline Followback Method (TLFB) which is a widely used, calendar-based retrospective measure of self-reported use of alcohol. The number of days drinking assessed is 28 days.

  Baseline to week 12

Secondary Outcomes (23)

• Change in total alcohol consumption

  Baseline to week 12

• Change in days of abstinence

  Baseline to week 12

• Change in phosphatidyl-ethanol (PEth)

  Baseline to week 12

• Change in Alcohol Use Disorders Identification Test (AUDIT)

  Baseline to week 12

• Change in Penn Alcohol Craving Scale (PACS) score

  Baseline to week 12

Other Outcomes (4)

• Role of the Music I

  before and after dosing

• Role of the Music II

  week 4

• Treatment expectancies

  Baseline

Study Arms (2)

Psilocybin-assisted therapy

EXPERIMENTAL

45 patients will receive a single administration of 25mg psilocybin given in a protocol of psychological support before, during and after dosing.

Drug: Psilocybin

Placebo-assisted therapy

PLACEBO COMPARATOR

45 patients will receive a single administration of placebo (lactose) given in a protocol of psychological support before, during and after dosing.

Drug: Maltodextrin

Interventions

Psilocybin DRUG

Psilocybin-assisted therapy

Psilocybin-assisted therapy

Maltodextrin DRUG

Placebo-assisted therapy

Placebo-assisted therapy

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Bodyweight of 50-110 kg
• AUD according to DSM-5 criteria and alcohol dependence according to ICD-10.
• AUD Identification Test (AUDIT) ≥ 15.

You may not qualify if:

• Current or previously diagnosed with any psychotic disorder or bipolar affective disorder.
• Immediate family member with a diagnosed psychotic disorder.
• History of delirium tremens or alcohol withdrawal seizures.
• History of suicide attempt or present suicidal ideation at screening.
• Withdrawal symptoms at screening (\>nine on the Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) (43).
• Present or former severe neurological disease including trauma with loss of consciousness \> 30 min.
• Impaired hepatic function (alanine transaminase \>210/135 units/l men/women)
• Cardiovascular disease defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris, myocardial infarction within the last 12 months or uncontrolled hypertension (systolic blood pressure \>165 mmHg, diastolic blood pressure \>95 mmHg).
• Present or former abnormal QTc (\>450/470 ms men/women).
• Any oOther active substance use disorders (except nicotine) defined as a Drug Use Disorder Identification Test score \>six/two (men/women) and investigator's clinical evaluation.
• Women who are pregnant, breastfeeding, or intend to become pregnant or are not using adequate contraceptive measures considered highly effective (44).
• Unable to speak or understand Danish.
• Any other condition that the clinician estimates can interfere with trial participation.

Sponsors & Collaborators

• Anders Fink-Jensen, MD, DMSci: lead
• The Neurobiology Research Unit at Copenhagen University Hospital Rigshospitalet: collaborator

Study Sites (1)

Psychiatric Center Copenhagen, Frederiksberg Hospital

Frederiksberg, 2000, Denmark

Location

Related Publications (1)

• Jensen ME, Stenbaek DS, Juul TS, Fisher PM, Ekstrom CT, Knudsen GM, Fink-Jensen A. 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). BMJ Open. 2022 Oct 14;12(10):e066019. doi: 10.1136/bmjopen-2022-066019.

  PMID: 36241352 DERIVED

MeSH Terms

Conditions

Alcoholism; Behavior, Addictive

Interventions

Psilocybin; maltodextrin

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Anders Fink-Jensen, Professor

  Psychiatric Center Copenhagen, Frederiksberg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: single-centre, randomised, double-blinded, placebo-controlled, 1:1 parallel-group clinical trial

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 13, 2022
• Study Start: September 1, 2023
• Primary Completion: December 22, 2025
• Study Completion: December 22, 2025
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

DK (1)