NCT04158778

Bristol Imperial MDMA in Alcoholism Study

Open-Label Proof of Concept Feasibility Study to Explore the Safety, Tolerability and Potential Role of MDMA-Assisted Psychotherapy for the Treatment of Detoxified Patients With Alcohol Use Disorder

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The Safety, Tolerability and Role of MDMA-Assisted Psychotherapy for the treatment of detoxified patients with Alcohol Use Disorder.

Detailed description

This is an open label within-subject feasibility study, in 20 patients with Alcohol Use Disorder who have recently undergone detoxification. All patients will receive MDMA-Assisted drug therapy. This study aims to assess if MDMA-Assisted Psychotherapy can be delivered safely and can be tolerated by patients with alcohol use disorder post-detoxification. Outcomes regarding abstinence from alcohol, quality of life and psychosocial functioning will be evaluated.

Conditions

• Alcohol Use Disorder

Interventions

Type	Name	Description
DRUG	MDMA	Two sessions of MDMA-assisted psychotherapy will take place (session 3 \& 7) within the 10 week course of psychotherapy. An initial dose of 125mg MDMA will be followed by an optional dose of 62.5mg 2 hours later.
OTHER	Psychotherapy	Two sessions of MDMA-assisted psychotherapy will take place (session 3 \& 7) within the 10 week course of psychotherapy.

Timeline

• Start date: 2018-04-18
• Primary completion: 2020-06-12
• Completion: 2020-06-12
• First posted: 2019-11-12
• Last updated: 2019-11-12

Locations

1 site across 1 country: United Kingdom