NCT04784143

Study Comparing Two Versus Three Active MDMA-assisted Sessions in U.S. Military Veterans With Chronic PTSD

A Phase 2, Open-Label, Randomized Comparative Effectiveness Study for MDMA-Assisted Psychotherapy in U.S. Veterans With Chronic PTSD

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Lykos Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if MDMA-assisted therapy is effective in U.S. military veterans with at least moderate chronic PTSD. The main question it aims to answer is: Are two versus three MDMA-assisted therapy sessions in an outpatient treatment clinic more effective? Researchers will compare two MDMA-assisted therapy sessions to three MDMA-assisted therapy sessions. Participants will undergo three non-drug preparatory sessions prior to their first MDMA-assisted therapy session. Each MDMA-assisted therapy session will be followed by three non-drug integrative therapy sessions.

Detailed description

This open-label, randomized study will assess the comparative effectiveness of two versus three active MDMA-assisted therapy sessions in U.S. military veterans with at least moderate chronic PTSD treated in an outpatient VA treatment clinic. The study will be conducted in up to 60 participants. Prior to the randomized portion of the study, each therapist pair team will treat one participant under the 3-session model, and one participant under the 2-session model. In total, 8 participants will be treated under this proof of principle therapist training lead-in. A 120 mg dose of MDMA, followed by a supplemental dose (60 mg) unless contraindicated, is administered during the treatment period with manualized psychotherapy in 2 or 3 open-label monthly Experimental Sessions. This \~ 8-12-week Treatment Period includes three Preparatory Sessions prior to the first MDMA-assisted session. During the treatment period, each Experimental Session is followed by three Integrative Sessions of non-drug therapy. The Primary Outcome measure, the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), is assessed by a centralized, blinded Independent Rater (IR) pool at post-treatment for each group.

Conditions

• PTSD

Interventions

Type	Name	Description
DRUG	Midomafetamine	120 mg midomafetamine HCl followed by a supplemental dose of 60 mg
BEHAVIORAL	Psychotherapy	Manualized psychotherapy performed by therapist team

Timeline

• Start date: 2021-11-08
• Primary completion: 2024-06-25
• Completion: 2024-06-27
• First posted: 2021-03-05
• Last updated: 2025-07-15
• Results posted: 2025-07-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study