A Multi-centre, Double-blinded, Placebo-controlled, Randomised, Phase II Clinical Trial for Psilocybin-assisted Therapy for Alcohol Use Disorder

NCT06444243 Phase 2 NOT_YET_RECRUITING

To explore the effectiveness of psilocybin-assisted therapy on reducing alcohol consumption in a double-blind, randomised, phase II clinical trial.

Details

Lead sponsor	University of Sydney
Phase	Phase 2
Status	NOT_YET_RECRUITING
Enrolment	90
Start date	2024-09
Completion	2025-12

Conditions

• Alcohol Use Disorder
• Alcohol Dependence
• Depression
• Anxiety

Interventions

• Psilocybin
• Niacin

Primary outcomes

• Frequency of Heavy Drinking Days (HDD) — 52 Weeks
  Frequency of HDD as measured by the Timeline Follow Back (TLFB) and validated by Phosphatidylethanol (PEth). HDD are defined as ≥4 drinks/day for women and ≥5 drinks/day for men.