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.
Erica Eaton, Christy Capone, Brian J Gully, Zoe E Brown, Mollie Monnig, Michael S Worden, Robert M Swift, Carolina L Haass-Koffler
Contemporary clinical trials communications October 1, 2024 DOI: 10.1016/j.conctc.2024.101333 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Open-label trial Randomized Peer reviewed |
|---|---|
| Sample size | 12 |
| Population | Military veterans with PTSD and alcohol use disorder |
| Intervention | MDMA-assisted therapy |
| Topics | Addiction MDMA PTSD |
| Keywords | Posttraumatic stress disorder Psychedelic assisted therapy Post-traumatic stress Combat trauma #veteranhealth veterans Military personnel Service members Ex-military #psychedelictherapy |
| Citations | 2 |
| Registration | NCT05943665 |
| Key findings | The manuscript reports the premise, design, and methodology of the first open-label trial of MDMA-AT for military veterans with PTSD and AUD. |
Abstract
Posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) commonly co-occur and are associated with more severe symptomatology than either disorder alone, increased risk of suicide, and poorer response to existing treatments. A promising therapeutic intervention is the integration of 3,4-methylenedioxymethamphetamine (MDMA) and psychotherapy. The Food and Drug Administration (FDA) designated MDMA- assisted therapy (MDMA-AT) as a Breakthrough Therapy for PTSD based on results from six Phase 2 clinical trials. Case data from the first study evaluating MDMA-AT study for AUD found the treatment was well tolerated and alcohol use was significantly reduced post treatment. This manuscript reports the premise, design, and methodology of the first open-label trial of MDMA-AT for military veterans (N = 12) with PTSD and AUD. Neuroimaging and biomarker data are included to evaluate brain changes, and neuroinflammation, pre-post treatment. The clinical component (comorbidity) and the regulatory processes (Schedule I drug) for setting up this clinical trial are long and complex. The research community will benefit from this work to establish common clinical trial outcomes, standardized protocols, and risk assessments for FDA approval. NCT05943665.
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 |
| 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 |