NCT05961527

Group MDMA-therapy for Veterans With PTSD

An Open-Label Feasibility and Safety Study of MDMA-Assisted Group Therapy for the Treatment of Posttraumatic Stress Disorder in Veterans

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Portland VA Research Foundation, Inc · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This Phase 2a, open-label, non-randomized, 3-cohort study assesses the feasibility and safety of MDMA-assisted group therapy for the treatment of PTSD in veterans. The study will be conducted in up to N=18 participants, recruited in three cohorts of six participants each and receive therapy sessions throughout their participation in these group cohorts.

Detailed description

To assess the feasibility and safety of MDMA-assisted group therapy for participants with at least moderate PTSD, the sponsor-investigator is conducting a phase 2, open-label, non-randomized, 3-cohort study. This novel treatment package consists of two once-monthly open-label MDMA Sessions combined with non-drug preparatory and integrative therapy administered in both individual and group sessions. The Primary Clinical Outcome measure, the Clinician Administered PTSD Scale (CAPS-5), evaluates changes in PTSD symptom severity and is assessed by a blinded centralized Independent Rater (IR) pool. The therapeutic approach will combine manualized MDMA-assisted therapy for PTSD with group therapy components.

Conditions

• PTSD

Interventions

Type	Name	Description
DRUG	MDMA	Initial dose of 120 mg MDMA HCL and optional supplemental dose of 60 mg MDMA HCL at 1.5 to 2 hours after first dose
BEHAVIORAL	Group Therapy	Standardized group psychotherapy performed by therapist team in combination with non-directive MDMA therapy

Timeline

• Start date: 2023-10-01
• Primary completion: 2025-03-14
• Completion: 2025-03-14
• First posted: 2023-07-27
• Last updated: 2025-06-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study