CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 62 target
Drug / intervention
Psilocybin (high dose) +1 moredrug
Likely dose
Not stated in record
Key inclusion· 16
  • ✓Severe Alcohol Use Disorder (sAUD) per DSM-V with ≥6 criteria confirmed by M.I.N.I 7.0.2
  • ✓Ages 21-64 years with BMI 17.5-30 kg/m²
  • ✓Want to stop or decrease drinking
  • ✓Not currently on pharmacological treatment for sAUD
Key exclusion· 24
  • ✕Allergy, hypersensitivity, or adverse reactions to psilocybin or hallucinogens
  • ✕Uncorrected hypertension
  • ✕Cardiovascular, hepatic, gastroenterological, hematologic, renal, endocrine, metabolic, inflammatory, neurological diseases or other somatic conditions posing risk
  • ✕Decompensated hepatic cirrhosis (Child B or C)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06160232
NCT06160232Phase 2RecruitingUpdate OverdueUpdated 22mo ago · Completion was 6mo ago
Enrollment Stalled
Update Overdue
CompareCT.gov

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

Brugmann University Hospital·interventional·Posted Dec 7, 2023·Updated Aug 7, 2024

In Brief

A Phase 2 clinical trial evaluating Psilocybin (high dose) and Active placebo (low dose of psilocybin) for Severe Alcohol Use Disorder. Currently recruiting, targeting 62 participants across 1 site.

Signals

Enrollment appears stalled

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Alcohol Use Disorder
CountriesBelgium
Collaborators--

Timeline

Phase 2RecruitingOverdue
202420252026
First PostedDec 7, 2023
Enrollment StartFeb 15, 2024
Primary CompletionDec 15, 2025
Study CompletionJun 15, 2026
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 2.6 years ago

Interventions

Psilocybin (high dose)drug

Psilocybin-assisted therapy

Active placebo (low dose of psilocybin)drug

Placebo-assisted therapy