NCT06444243

Psilocybin-assisted Therapy for Alcohol Use Disorder

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: University of Sydney · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

New strategies for treating Alcohol Use Disorder (AUD) are urgently needed. Recent evidence has shown promising results for psychedelic-assisted therapies, particularly psilocybin, which has demonstrated efficacy in reducing alcohol consumption and improving psychological well-being. This study aims to evaluate the clinical efficacy and tolerability of psilocybin-assisted therapy compared to a control (niacin) in reducing heavy drinking days (HDD) per week among individuals with AUD. Primary Objective To conduct a double-blind, randomised controlled trial with 90 participants diagnosed with Alcohol Use Disorder (AUD). The primary aim is to compare the efficacy of psilocybin-assisted therapy (two sessions of psilocybin, 25 mg per dosing session) versus control (niacin 250mg) and therapy in reducing alcohol consumption, specifically measuring the number of heavy drinking days (HDD) per week. Secondary Objectives To compare the efficacy of psilocybin-assisted therapy versus control in improving the characteristics of AUD and addressing common comorbidities associated with AUD, including depression and anxiety. Study Design The trial will employ a double-blind, randomised, controlled design. A sample of 90 individuals with AUD will undergo 14 weeks of treatment, which includes 12 therapy sessions and 2 dosing sessions with either psilocybin (25 mg) or control (niacin 250mg). Participants will be assessed for changes in alcohol consumption patterns and improvements in symptoms of depression and anxiety.

Conditions

• Alcohol Use Disorder
• Alcohol Dependence
• Depression
• Anxiety

Interventions

Type	Name	Description
DRUG	Psilocybin	Psilocybin is a naturally occurring psychedelic prodrug compound produced by more than 200 species of fungi.
DRUG	Niacin	A nutrient in the vitamin B complex that the body needs in small amounts to function and stay healthy. Niacin helps some enzymes work properly and helps skin, nerves, and the digestive tract stay healthy. Niacin is found in many plant and animal products. Niacin will be used at a concentration of 250mg as an active control.

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-07-01
• Completion: 2025-12-01
• First posted: 2024-06-05
• Last updated: 2024-06-10