First study of safety and tolerability of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in patients with alcohol use disorder: preliminary data on the first four participants

This paper presents data on the first four of 14 participants in the open-label trial on the safety and tolerability of MDMA-assisted psychotherapy for alcohol use disorder.

Abstract

We present the preliminary data in an ongoing open-label safety and tolerability proof of concept study exploring the potential role for 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in treating patients with alcohol use disorder. At this stage, seven participants have completed the full 8-week MDMA-assisted psychotherapy course, including two therapy sessions each with MDMA. This paper focuses on the safety and tolerability of the therapeutic course for the first four participants to complete treatment. Longer-term outcomes of drinking behaviour will be presented later when the full project data are published. Results show all four participants have successfully tolerated the treatment. There have been no serious adverse events related to MDMA, no unexpected physiological responses to the MDMA sessions or changes to blood results or electrocardiograms, measured before and after the 8-week course. We conclude that the treatment is well- tolerated and are making plans to expand the project into a randomised placebo-controlled study.

Authors: Ben Sessa, Chloe Sakal, Steve O’Brien & David J. Nutt

Notes

The paper with the full results of this study by Sessa and colleagues (2021) has been published.

Become a psychedelic insider!

With a Blossom membership you will always be in the know.

📰 Twice a week newsletter about the psychedelic research

✔️ Unlimited access to our database and original articles

🖊️ Add (private) notes and comments to each page

See all benefits
0 Comments
Inline Feedbacks
View all comments
0
Would love your thoughts, please comment.x
()
x