First study of safety and tolerability of 3,4-methylenedioxymethamphetamine-assisted psychotherapy in patients with alcohol use disorder

Ben Sessa*, Laurie Higbed, Steve O'Brien, Claire Durant, Chloe Sakal, Daniel Titheradge, Tim M Williams, Anna Rose-Morris, Elsa Brew-Girard, Sam Burrows, Chantelle Wiseman, Sue Wilson, James Rickard, David J Nutt

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)peer-review

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Abstract

Background:
3,4-methylenedioxymethamphetamine (MDMA) therapy has qualities that make it potentially well suited for patients with addictions, but this has never been explored in a research study. We present data from the Bristol Imperial MDMA in Alcoholism (BIMA) study. This is the first MDMA addiction study, an open-label safety and tolerability proof-of-concept study investigating the potential role for MDMA therapy in treating patients with alcohol use disorder (AUD).

Aims:
This study aimed to assess if MDMA-assisted psychotherapy can be delivered safely and can be tolerated by patients with AUD post detoxification. Outcomes regarding drinking behaviour, quality of life and psychosocial functioning were evaluated.

Methods:
Fourteen patients with AUD completed a community alcohol detoxification and received an eight-week course of recovery-based therapy. Participants received two sessions with MDMA (187.5 mg each session). Psychological support was provided before, during and after each session. Safety and tolerability were assessed alongside psychological and physiological outcome measures. Alcohol use behaviour, mental well-being and functioning data were collected for nine months after alcohol detoxification.

Results:
MDMA treatment was well tolerated by all participants. No unexpected adverse events were observed. Psychosocial functioning improved across the cohort. Regarding alcohol use, at nine months post detox, the average units of alcohol consumption by participants was 18.7 units per week compared to 130.6 units per week before the detox. This compares favourably to a previous observational study (the ‘Outcomes’ study) by the same team with a similar population of people with AUD.

Conclusions:
This study provides preliminary support for the safety and tolerability of a novel intervention for AUD post detox. Further trials to examine better the therapeutic potential of this approach are now indicated.
Original languageEnglish
Pages (from-to)375-383
Number of pages9
JournalJournal of Psychopharmacology
Volume35
Issue number4
Early online date18 Feb 2021
DOIs
Publication statusPublished - 1 Apr 2021

Bibliographical note

Funding Information:
We also wish to express thanks to Minirigs ? the Bristol-based electronics company that provided the stereo equipment for the experimental sessions. We are grateful to Dr Mendel Kaelen, who provided the playlists for the MDMA therapy sessions. Thank you to all the staff at the Clinical Research and Imaging Centre (particularly Jade, Cathy and Hannah). Enormous gratitude to the local staff and the research and development team at Addaction, without whose support this project would never have happened. In particular, we thank our expert user, Mr Kevin Speller. The staff at MAPS ? especially Rick Doblin, Michael Mithoefer and Ilsa Jerome ? provided essential support and guidance throughout the project ? including provision of the IB and ongoing advice regarding MDMA pharmacology and therapeutic issues. We are grateful to Dr James Rickard, Chief Scientific Officer at Biotherapy Services, for providing pharmacy support, to Dr Tim White (at Guy?s and St Thomas? NHS Foundation Trust Pharmacy Manufacturing Unit, London, UK) for production of the IMP and to Dr Liz McCullough at BRI pharmacy for storing and dispensing the study medication. And finally, we are extremely grateful to the pool of local junior doctors who gave their time to act as post-MDMA night sitters after each of the participants drug-assisted sessions, including Sakal, C., (night sitters lead), Titheradge, D., Rose-Morris, A., Brew-Girard, E., Alderton, K., Burrows, S., Secker, A., Loysen, S., Hall, K., Lilford, P., Flowers, J., Wright, L., Roberts, R., Lawton, S., Meyer, A., Salter, E., Guy, J., Brown, R. and Rifkin-Zybutz, R. Most importantly, we extend enormous gratitude to the patients who participated in this study. The authors disclosed receipt of the following financial support for the research, authorship and/or publication of this article: The authors are grateful to the Alexander Mosley Charitable Trust for the entire funding of the study.

Funding Information:
The authors disclosed receipt of the following financial support for the research, authorship and/or publication of this article: The authors are grateful to the Alexander Mosley Charitable Trust for the entire funding of the study.

Publisher Copyright:
© The Author(s) 2021.

Keywords

  • MDMA
  • Alcohol use disorder
  • Psychotherapy
  • Alcoholism
  • Psychedelics

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