This open-label study (n=14) investigated the effect of MDMA-assisted psychotherapy in treating patients with alcoholism (Alcohol Use Disorder, AUD). The patients were first detoxified and subsequently underwent eight weeks of therapy, including two high doses of MDMA (125mg + 62.5mg booster) plus therapy.
This study was completed with 14 participants versus the original 20 indicated on the trial.
Compound MDMA
Country United Kingdom
Visit trial
Status
Completed
Results Published
Yes
Start date
18 April 2018
End date
12 June 2020
Chance of happening
100%
Phase
Phase I
Design
Open
Type
Interventional
Generation
First
Participants
14
Sex
All
Age
18- 65
Therapy
Yes
Trial Details
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.NCT Number NCT04158778
Sponsors & Collaborators
Imperial College LondonThe 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 disorderThis 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).