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.

Status Completed
Results Published Yes
Start date 20 April 2020
End date 20 April 2021
Chance of happening 100%
Phase Phase I
Design Open
Type Interventional
Generation First
Participants 14
Sex All
Age 18- 99
Therapy No

Trial Details



NCT 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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