Bristol Imperial MDMA in Alcoholism Study

Brief Summary

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

Intervention / Treatment

  • Drug: MDMA
  • Other: Psychotherapy

Condition or Disease

  • Alcohol Use Disorder

Phase

Study Design

Study type: Interventional
Status: Unknown status
Study results: No Results Available
Age: 18 Years to 65 Years   (Adult, Older Adult)
Enrollment: 20 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Apr 18, 2018
Primary Completion: Jun 12, 2020
Completion Date: Jun 12, 2020
Study First Posted: Nov 12, 2019
Results First Posted: Aug 30, 2020
Last Updated: Nov 12, 2019

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

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.

Eligibility Criteria

Sex: All
Minimum Age: 18
Maximum Age: 65

More Details

NCT Number: NCT04158778
Acronym: BIMA
Other IDs: BIMA2016|2016-002547-42
Study URL: https://ClinicalTrials.gov/show/NCT04158778
Last updated: Jun 16, 2022