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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)

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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.

Comparable studies

Other non-randomized and open-label trials on MDMA and psychedelic-assisted therapy, most cited first.

Study Year Design Participants
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. Adults with chronic, treatment-resistant PTSD 2013 Long-term follow-up of a completed trial n = 19
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
Culturally informed research design issues in a study for MDMA-assisted psychotherapy for posttraumatic stress disorder People of color with posttraumatic stress disorder 2019 Phase 2 open-label multisite study
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
3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for victims of sexual abuse with severe post-traumatic stress disorder: an open label pilot study in Brazil. Patients with PTSD secondary to sexual abuse 2021 Open-label clinical trial n = 3

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