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 via PubMed
Summary
AI-generated from the abstractAn open-label pilot trial will test whether 100 mg of MDMA combined with massed exposure therapy—daily sessions for two weeks—is feasible for treating PTSD. The authors argue that combining MDMA with a gold-standard exposure treatment has translational support and strong dissemination potential. The study aims to enroll at least 15 adults with PTSD over two years to develop a treatment manual, which will later be tested in a randomized, placebo-controlled trial. This approach could improve the ability to treat PTSD.
Study at a glance
| 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 |
| Citations | 5 |
| Registration | NCT05746572 |
| Key finding | 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.