First study of safety and tolerability of 3,4-methylenedioxymethamphetamine-assisted psychotherapy in patients with alcohol use disorder
In the first open‑label study of MDMA‑assisted psychotherapy for alcohol use disorder (BIMA), 14 post‑detox participants tolerated two 187.5 mg MDMA sessions with no unexpected adverse events and showed improved psychosocial functioning. At nine months average alcohol use fell from 130.6 to 18.7 units per week, supporting safety and signalling therapeutic potential that now warrants controlled trials.
Authors
- Thomas Williams
- Ben Sessa
Published
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.
Research Summary of 'First study of safety and tolerability of 3,4-methylenedioxymethamphetamine-assisted psychotherapy in patients with alcohol use disorder'
Introduction
Alcohol use disorder (AUD) is common and heterogenous, and many patients present with comorbid psychological trauma, depression, social anxiety and social exclusion. Current pharmacological treatments (for example acamprosate, naltrexone, nalmefene, disulfiram) and psychosocial programmes have limited effectiveness for some patients, and there is growing interest in therapeutic approaches that improve engagement with psychotherapy and interrupt automatic responses to stress and craving. Earlier research on 3,4-methylenedioxymethamphetamine (MDMA) has shown that it elevates mood, increases sociability and reduces amygdala reactivity to negative memories; these properties have motivated clinical trials of MDMA-assisted psychotherapy in PTSD and suggest potential applicability to addictions, but MDMA has not previously been evaluated experimentally for AUD. Sessa and colleagues report the Bristol Imperial MDMA in Alcoholism (BIMA) study, an open-label, within-subjects, proof-of-concept investigation designed primarily to assess safety and tolerability of MDMA-assisted psychotherapy delivered after successful alcohol detoxification. The study also collected preliminary outcome data on drinking behaviour, mental well-being, psychosocial functioning and quality of life up to nine months post-detoxification to inform future controlled trials.
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Study Details
- Study Typeindividual
- Journal
- Compound
- Topics
- Authors
- APA Citation
Sessa, B., Higbed, L., O’Brien, S., Durant, C., Sakal, C., Titheradge, D., Williams, T. M., Rose-Morris, A., Brew-Girard, E., Burrows, S., Wiseman, C., Wilson, S., Rickard, J., & Nutt, D. J. (2021). First study of safety and tolerability of 3,4-methylenedioxymethamphetamine-assisted psychotherapy in patients with alcohol use disorder. Journal of Psychopharmacology, 35(4), 375-383. https://doi.org/10.1177/0269881121991792
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Colcott, J., Guerin, A. A., Carter, O. et al. · Neuropsychopharmacology (2024)
Luoma, J. B., Allen, L. R., Gold, V. et al. · Psychedelic Medicine (2024)
Zeifman, R. J., Kettner, H., Ross, S. et al. · European Journal of Psychotraumatology (2024)
Van Vugt, A. S., Zijlmans, J., Lindauer, R. et al. · Drug Science Policy and Law (2023)
Heifets, B. D., Olson, D. E. · Neuropsychopharmacology (2023)
Zafar, R., Siegel, M., Harding, R. et al. · Frontiers in Psychiatry (2023)
Jones, J. L. · Frontiers in Psychiatry (2023)
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Narine, K., Campbell, I., Dyck, J. et al. · Neuropharmacology (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)
Sarparast, A., Thomas, K., Malcolm, B. et al. · Psychopharmacology (2022)
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Sessa, B., Aday, J. S., Curran, H. V. et al. · Journal of Psychopharmacology (2021)
Bird, C. I. V., Modlin, N. L., Rucker, J. · International Review of Psychiatry (2021)
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