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.
Ben Sessa, Chloe Sakal, Steve O’Brien, David Nutt
BMJ Case Reports July 15, 2019 DOI: 10.1136/bcr-2019-230109 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Open-label safety and tolerability proof of concept study Randomized Placebo-controlled Peer reviewed |
|---|---|
| Sample size | 4 |
| Population | Patients with alcohol use disorder |
| Intervention | MDMA-assisted psychotherapy |
| Duration | 8-week course |
| Topics | Addiction Psychedelic-assisted therapy MDMA |
| Keywords | MDMA Therapy MDMA-Assisted Psychotherapy Ecstasy treatment Aud Alcoholism Alcohol addiction Alcohol dependence Addiction treatment Substance abuse treatment Recovery Drug treatment Clinical research Preliminary results Medical research Drug trials Safety study |
| Citations | 55 |
| Key points | All four participants tolerated the 8-week MDMA-assisted psychotherapy course, with no serious adverse events related to MDMA and no unexpected physiological, blood-test, or electrocardiogram changes. The authors conclude the treatment is well tolerated and plan to expand into a randomized placebo-controlled study. |
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.
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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The first four participants tolerated the 8-week MDMA-assisted psychotherapy course with no serious MDMA-related adverse events and no unexpected physiological, blood, or ECG changes; drinking outcomes were not yet reported.
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-assisted psychotherapy in patients with alcohol use disorder. Patients with alcohol use disorder (AUD) following community alcohol detoxification | 2021 | Open-label safety and tolerability proof-of-concept study | n = 14 |
| 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 |
Citations in the library
Cited by 47
- Reviewing the Potential of Psychedelics for the Treatment of PTSD The International Journal of Neuropsychopharmacology March 12, 2020
- Hallucinogens in Mental Health: Preclinical and Clinical Studies on LSD, Psilocybin, MDMA, and Ketamine Journal of Neuroscience November 30, 2020
- Adverse events in clinical treatments with serotonergic psychedelics and MDMA: A mixed-methods systematic review Journal of Psychopharmacology August 26, 2022
- Psychedelic-Assisted Psychotherapy—A Systematic Review of Associated Psychological Interventions Frontiers in Psychology June 10, 2022
- Efficacy and safety of psychedelics for the treatment of mental disorders: A systematic review and meta-analysis. Psychiatry Research May 1, 2024
and 42 more in the library
Cites 8
- The safety and efficacy of {+/-}3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study. Journal of Psychopharmacology July 19, 2010
- Subjective Reports of the Effects of MDMA in a Clinical Setting Journal of Psychoactive Drugs October 1, 1986
- A randomized, controlled pilot study of MDMA (±3,4-Methylenedioxymethamphetamine)-assisted psychotherapy for treatment of resistant, chronic Post-Traumatic Stress Disorder (PTSD) Journal of Psychopharmacology October 31, 2012
- Durability of improvement in post-traumatic stress disorder symptoms and absence of harmful effects or drug dependency after 3,4-methylenedioxymethamphetamine-assisted psychotherapy: a prospective long-term follow-up study. Journal of Psychopharmacology 2013
- Why MDMA therapy for alcohol use disorder? And why now? Neuropharmacology November 1, 2018
and 3 more in the library