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.
Contemporary clinical trials communications – October 01, 2024
Source: PubMed
Summary
Veterans battling both PTSD and alcohol use disorder may find hope in a groundbreaking therapy approach. This pioneering trial explores MDMA-assisted psychotherapy as a dual treatment, combining supervised MDMA sessions with therapeutic support. The study follows 12 veterans through comprehensive treatment, tracking brain changes and measuring improvements in both trauma symptoms and alcohol use. Early indicators suggest this innovative approach could offer relief where traditional treatments have fallen short.
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.