Open-label safety, tolerability and proof-of-concept study investigating the potential role for MDMA-Assisted Psychotherapy in treating patients with alcohol use disorder

This Phase I study assessed the safety and efficacy of using MDMA-assisted psychotherapy to treat alcohol use disorder (AUD).

This open-label study (n=14) with MDMA-assisted psychotherapy (2 sessions;187.5mg) found it to be well-tolerated and safe to use.

Topic Addiction Alcohol Use Disorder
Compound MDMA
Country United Kingdom
Visit trial
Status Completed
Results Published Yes
Start date 20 April 2020
End date 20 April 2021
Phase Phase I
Design Open
Type Interventional
Generation First
Participants 14
Sex All
Age 18- 99
Therapy No

Trial Details



Trial Number

Sponsors & Collaborators

Awakn Life Sciences
AWAKN Life Sciences aims to bring psychedelics therapy to the UK. Under this company fall three arms; psychedelic research, clinic platform, and practitioner training.

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

Papers

First study of safety and tolerability of 3,4-methylenedioxymethamphetamine-assisted psychotherapy in patients with alcohol use disorder
This open-label study (n=14) with MDMA-assisted psychotherapy (2 sessions;187.5mg) found it well-tolerated and safe to use. The average consumption of alcohol nine months later was 18.7 units, versus 130.6 units before the detox (start of the study).

Data attribution

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