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

This open-label proof of concept feasibility study (n=20), sponsored by Imperial College London, explores the safety, tolerability, and potential role of MDMA-assisted psychotherapy in treating detoxified patients with alcohol use disorder (AUD).

Conducted under the protocol code BIMA2016, also known as the Bristol Imperial MDMA in Alcoholism Study (BIMA), the trial aims to assess if MDMA-assisted psychotherapy can be safely delivered and is acceptable to recently detoxified alcohol-dependent patients.

The study, which began on January 3, 2017, and is no longer in the EU/EEA, involves a total of 20 adult participants aged between 18 and 65 years, with an equal gender distribution.

The primary inclusion criteria include informed consent, a diagnosis of alcohol use disorder, successful alcohol detoxification, proficiency in English, and compliance with the protocol requirements. Exclusion criteria consist of lacking capacity, certain psychiatric disorders, significant medical conditions, regular use of ecstasy, and certain medication use during the MDMA-assisted therapy period.

The trial’s primary endpoint is to determine the safety, tolerability, and acceptability of MDMA-assisted psychotherapy, measured by adverse events, completion rates of the therapy, and acceptance of booster doses. Secondary endpoints include assessing the intensity of MDMA effects, subjective sleep ratings, mood ratings, drinking behaviour, quality of life, psychosocial functioning, and medication use. These measures are evaluated during the treatment period and at follow-up assessments conducted at 3, 6, and 9 months post-treatment.

The trial has been authorised by the Competent Authority and received a favourable opinion from the Ethics Committee. The trial concludes with participants receiving treatment as usual beyond their participation in the study.

Topic Alcohol Use Disorder Addiction
Compound MDMA
Country United Kingdom
Visit trial
Status Unknown status
Results Published No
Start date 03 January 2017
End date 30 December 2025
Phase Phase II
Design Open
Type Interventional
Generation First
Participants 20
Sex All
Age 18- 65
Therapy Yes

Trial Details

This open-label study, sponsored by Imperial College London, investigates the safety and potential benefits of MDMA-assisted psychotherapy for alcohol use disorder in 20 adults aged 18-65. It assesses safety, tolerability, and acceptability, with primary endpoints including adverse events and completion rates. Secondary endpoints include mood ratings, drinking behaviour, and quality of life.

NCT Number 2016-002547-42

Sponsors & Collaborators

Imperial College London
The Centre for Psychedelic Research studies the action (in the brain) and clinical use of psychedelics, with a focus on depression.

Data attribution

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