MMP-1 Safety and efficacy of MDMA-assisted therapy for Post-Traumatic Stress Disorder in Military Veterans and First Responders: a randomised waitlist-controlled clinical trial

Abstract

MMP-1 is a randomised waitlist-controlled clinical trial evaluating the safety and efficacy of MDMA-assisted therapy (MDMA-AT) for chronic PTSD in military veterans and first responders. PTSD in these groups is often severe and treatment-resistant, highlighting the need for novel interventions. MDMA-AT combines two MDMA dosing sessions (120 mg with an optional 40 mg supplemental dose) with trauma-focused psychotherapy to support trauma processing. The study enrols 24 participants who complete trial assessments and intervention sessions in Melbourne, Australia. Participants are randomised to early access treatment or waitlist followed by treatment, enabling comparison between the experimental intervention and treatment-as-usual at the primary endpoint. The primary aim is to determine whether MDMA-AT reduces PTSD symptom severity, measured using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at Week 18. Secondary aims assess safety, functioning, quality of life, and comorbid symptoms. MMP-1 trial details: Approved by MUHREC (37226) on 06/04/2023; UTN: U1111-1292-5966; ANZCTR: ACTRN12623000971639.

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