Efficacy and Safety of Psilocybin-Assisted Psychotherapy in Adults with Alcohol Use Disorder
Research type
Research Study
Full title
A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Clinical Trial to Evaluate Efficacy and Safety of Psilocybin-Assisted Psychotherapy in Adults with Alcohol Use Disorder.
IRAS ID
1007206
Contact name
Damian Kettlewell
Contact email
Sponsor organisation
Clairvoyant Therapeutics Inc.
Eudract number
2021-006200-33
Clinicaltrials.gov Identifier
Research summary
The aim of the study is to test the safety and therapeutic effectiveness of the psychedelic drug, psilocybin (often found in mushrooms) versus a placebo in adults aged 18 - 70 with alcohol use disorder (AUD). The purpose of the trial is to determine whether the psychedelic drug can reduce the debilitating symptoms and addictive tendencies associated with alcohol use disorder. Importantly, this may be helpful to patients where previous medication has not helped. Furthermore, people with alcohol use disorder may also experience symptoms relating to other disorders (depression, anxiety, post traumatic stress disorder etc.) which may be reduced with therapy alongside taking a psychedelic intervention. To be eligible for the study, participants are required to have a diagnosis of moderate to severe Alcohol Use Disorder from a health professional. Approximately 20 participants with Alcohol Use Disorder will receive a course of therapy accompanied by two study medication visits where they will receive either 25mg psilocybin or placebo, and will be followed up for 16 weeks after treatment.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
23/LO/0084
Date of REC Opinion
29 Sep 2023
REC opinion
Further Information Unfavourable Opinion