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 A Rickard, David Nutt
Journal of Psychopharmacology February 18, 2021 DOI: 10.1177/0269881121991792 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Open-label safety and tolerability proof-of-concept study Peer reviewed |
|---|---|
| Sample size | 14 |
| Population | Patients with alcohol use disorder (AUD) following community alcohol detoxification |
| Interventions | MDMA recovery-based therapy psychological support |
| Dose | 187.5 mg each session |
| Duration | Eight-week course of recovery-based therapy; data collected for nine months after alcohol detoxification |
| Topics | Addiction MDMA Psychedelic-assisted therapy |
| Keywords | Aud Alcoholism Alcohol addiction Alcohol dependence Integrated therapy Combination treatment Combined therapy Multimodal therapy Comprehensive treatment Pharmacotherapy Drug therapy Medication Compound treatment Pharmaceutical intervention Psychotherapy Behavioral therapy Talk therapy Counseling Clinical research Medical study Investigation Clinical trial |
| Citations | 123 |
| Key points | MDMA-assisted psychotherapy was well tolerated by all 14 participants with alcohol use disorder, with no unexpected adverse events and improved psychosocial functioning. Average alcohol consumption fell from 130.6 units per week before detox to 18.7 units per week nine months after detox, which the authors say compares favourably with a previous observational study in a similar population. The authors describe this as preliminary support for safety and tolerability and call for further trials. |
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.
In the evidence
This study is part of the evidence base for a synthesis in the library. Here is how each one recorded it.
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MDMA-assisted psychotherapy was reported as safe and tolerable in patients with alcohol use disorder.
Synthesized
Comparable studies
Other non-randomized and open-label trials on MDMA for addiction, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| 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. Patients with alcohol use disorder | 2019 | Open-label safety and tolerability proof of concept study | n = 4 |
| Design and methodology of the first open-label trial of MDMA-assisted therapy for veterans with post-traumatic stress disorder and alcohol use disorder: Considerations for a randomized controlled trial. Military veterans with PTSD and alcohol use disorder | 2024 | Open-label trial | n = 12 |