Psilocybin-assisted Therapy for Treatment of Alcohol Use Disorder

Status Recruiting

Clinical Trial 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).

Clinical Trial Description

To establish efficacy, we will investigate a single dose of psilocybin versus placebo in a randomised, double-blinded, placebo-controlled 12 weeks clinical trial. 90 patients, aged 20-70 years, diagnosed with alcohol use disorder and treatment seeking will be recruited from the community via advertisement and referrals from general practitioners and hospital units. The psilocybin or placebo is administered within a protocol of psychological support before, during and after the dosing. Outcome assessments will be carried out one, four, eight- and 12 weeks post dosing. The primary outcome is reduction in the percentage of heavy drinking days from baseline to follow-up at 12 weeks. Key secondary outcomes include 1) phosphatidyl-ethanol as an objective biomarker for alcohol consumption 2) plasma psilocin, the active metabolite, to establish a possible therapeutic range and 3) the acute subjective drug experience as a possible predictor of treatment outcome. Furthermore, we will investigate the neurobiological underpinnings of the possible treatment effects by use of functional magnetic resonance brain imaging one week post dosing. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05416229
Study type	Interventional
Source	Psychiatric Centre Rigshospitalet
Contact	Mathias E Jensen, MD
Phone	+45 61634663
Email	mathias.ebbesen.jensen.01@regionh.dk
Status	Recruiting
Phase	Phase 2
Start date	September 1, 2023
Completion date	November 2025

View Details

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