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
In this open‑label proof‑of‑concept study, the first four participants with alcohol use disorder tolerated an 8‑week MDMA‑assisted psychotherapy programme (two MDMA sessions each) with no MDMA‑related serious adverse events or clinically significant physiological, ECG or laboratory changes, supporting safety and informing plans for a randomised placebo‑controlled trial.
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.
Research Summary of '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'
Introduction
Earlier research has examined MDMA-assisted psychotherapy primarily for post-traumatic stress disorder (PTSD), and recent studies of classical psychedelics have suggested potential in treating various addictions. Despite this background, no prior study had investigated MDMA-assisted psychotherapy specifically for alcohol use disorder (AUD). The authors frame AUD as a major public-health problem in England, with high prevalence of harmful drinking, substantial morbidity and mortality, frequent comorbid psychological trauma, depression and social anxiety, and poor long-term outcomes with existing treatments (relapse rates cited as high as 60% at 12 months and 80% at 3 years). Sessa and colleagues set out to examine the safety and tolerability of MDMA-assisted psychotherapy in people with AUD, reporting preliminary data from the first four participants in an ongoing open-label study. The report aims to describe participant characteristics, the intervention protocol, physiological and psychological safety monitoring, and early signals of clinical change during the 8-week therapy course and initial follow-up periods.
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Study Details
- Study Typeindividual
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- APA Citation
Sessa, B., Sakal, C., O’Brien, S., & Nutt, D. (2019). 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. BMJ Case Reports, 12(7), e230109. https://doi.org/10.1136/bcr-2019-230109
References (6)
Papers cited by this study that are also in Blossom
Jerome, L., Schuster, S., Yazar-Klosinski, B. · Current Drug Abuse Reviews (2013)
Sessa, B., Johnson, M. W. · British Journal of Psychiatry (2018)
Sessa, B. · Neuropharmacology (2017)
Greer, G. R. · Journal of Psychoactive Drugs (1986)
Mithoefer, M. C., Wagner, M. T., Mithoefer, A. T. et al. · Journal of Psychopharmacology (2010)
Mithoefer, M. C., Wagner, M. T., Mithoefer, A. T. et al. · Journal of Psychopharmacology (2012)
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Traynor, J. M., Roberts, D. E., Ross, S. et al. · Focus (2022)
Thal, S. B., Wieberneit, M., Sharbanee, J. M. et al. · Journal of Psychopharmacology (2022)
Breeksema, J. J., Kuin, B. W., Kamphuis, J. et al. · Journal of Psychopharmacology (2022)
Cavarra, M., Falzone, A., Ramaekers, J. G. et al. · Frontiers in Psychology (2022)
Perkins, D., Opaleye, E. S., Simonová, H. et al. · Drug and Alcohol Review (2021)
Bird, C. I. V., Modlin, N. L., Rucker, J. · International Review of Psychiatry (2021)
de Wit, H., Bershad, A. K., Grob, C. S. · Journal of Psychopharmacology (2021)
Hibicke, M., Gobbi, G. · Journal of Neuroscience (2020)
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Krediet, E., Bostoen, T., Breeksema, J. J. et al. · International Journal of Neuropsychopharmacology (2020)
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