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Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder

NCT06160232 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2024-08-07

No results posted yet for this study

Summary

Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder: Protocol for a Double-Blind, Randomized, Placebo-Controlled, 7-month Parallel-Group Phase II Superiority Trial

Conditions

  • Severe Alcohol Use Disorder

Interventions

DRUG

Psilocybin (high dose)

Psilocybin-assisted therapy

DRUG

Active placebo (low dose of psilocybin)

Placebo-assisted therapy

Sponsors & Collaborators

  • Brugmann University Hospital

    lead OTHER

Principal Investigators

  • Charles Kornreich, M.D. Ph.D. · Brugmann University Hospital, Free University of Brussels

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-15
Primary Completion
2025-12-15
Completion
2026-06-15

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06160232 on ClinicalTrials.gov