The METEMP protocol: Massed exposure therapy enhanced with MDMA for PTSD.
Jessica L Maples-Keller, Boadie W Dunlop, Barbara O Rothbaum
Contemporary clinical trials communications February 1, 2025 DOI: 10.1016/j.conctc.2024.101400 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Open label pilot trial Randomized Placebo-controlled Open-label Pilot study Peer reviewed |
|---|---|
| Sample size | 15 |
| Population | Adults with PTSD |
| Interventions | MDMA massed exposure therapy |
| Dose | 100 mg |
| Duration | Two weeks of daily exposure therapy sessions |
| Topics | MDMA Psychedelic-assisted therapy PTSD |
| Keywords | Clinical trial Exposure therapy PTSD Treatment Clinical research Mental health innovation Drug-assisted psychotherapy |
| Citations | 5 |
| Registration | NCT05746572 |
| Key findings | The study will assess the feasibility of combining MDMA with massed exposure therapy for PTSD, with the goal of developing a manual for a future randomized controlled trial. |
Abstract
This article describes the rationale and the specific methods for an open label pilot trial of 100 mg MDMA in combination with massed exposure therapy for PTSD, a treatment which involves daily exposure therapy sessions for two weeks which has found to be effective. We review the need for novel PTSD treatments and the existing research on MDMA-assisted therapy, and then describe the rationale for this novel treatment approach, including combining MDMA with a gold standard treatment, translational support for this treatment, strong dissemination potential, and strengths of providing massed exposure treatment. The specific methods of the open label pilot study are presented, followed by conclusions and future directions for this research. This study will enroll at least 15 adults with PTSD over the next 2 years in order to identify feasibility and lead to a manual describing how to combine MDMA with exposure therapy, tested in a randomized, placebo-controlled trial, with significant promise for dissemination and improving our ability to treat PTSD. ClinicalTrials.gov identifier: NCT05746572.