NCT00090064

MDMA-Assisted Psychotherapy in People With Posttraumatic Stress Disorder

Phase II Clinical Trial Testing the Safety and Efficacy of 3,4-Methylenedioxymethamphetamine (MDMA)-Assisted Psychotherapy in Subjects With Chronic Posttraumatic Stress Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Lykos Therapeutics · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare MDMA-assisted therapy to placebo with therapy in people with chronic, treatment-resistant posttraumatic stress disorder (PTSD). The main question it aims to answer is: Is there a reduction in PTSD symptoms among people given MDMA-assisted therapy compared to placebo with therapy? Participants will receive either MDMA-assisted therapy or placebo with therapy during two blinded experimental sessions spaced three to five weeks apart. During experimental sessions, participants receive an initial dose of 125 mg of MDMA HCl, or placebo, followed by a dose of 62.5 mg of MDMA HCl, or placebo. During this treatment period, participants will also undergo non-drug preparatory psychotherapy sessions and non-drug integrative sessions. The study will test whether MDMA-assisted therapy can be safely given to participants. Researchers will compare PTSD symptoms in the MDMA-assisted therapy group to the placebo with therapy group to see if there is a reduction in symptoms after the treatment period.

Detailed description

This randomized, double-blind placebo-controlled pilot study assessed the safety and effectiveness of MDMA-assisted therapy among people with chronic, treatment-resistant PTSD, including veterans. Participants were assigned to receive either MDMA-assisted therapy or placebo with therapy during two blinded experimental sessions spaced three to five weeks apart during Stage 1 of the study. During these experimental sessions, participants received an initial dose of 125 mg of MDMA HCl followed by a supplemental dose of 62.5 mg of MDMA HCl, or they received initial and supplemental doses of inactive placebo. Psychotherapists and independent raters were blinded to participants' treatment conditions. This treatment period also consisted of non-drug preparatory therapy sessions and non-drug integration therapy sessions. During Stage 2 of the study, the blind was broken and participants assigned to receive MDMA-assisted therapy in Stage 1 underwent a third open-label experimental session of MDMA-assisted therapy. Participants assigned placebo with therapy during Stage 1 who chose to enroll in Stage 2 underwent three open-label sessions of MDMA-assisted therapy. Outcome measures were administered two months after the second experimental session in Stage 1 and four to six weeks after the second MDMA-assisted therapy session in Stage 2. A final data-collection session took place at two months after the third experimental session. The primary objective of the study was to measure change in PTSD symptoms via CAPS-IV across the study in participants receiving MDMA-assisted therapy versus placebo with therapy.

Conditions

• Posttraumatic Stress Disorder

Interventions

Type	Name	Description
DRUG	Midomafetamine HCl	125 mg of midomafetamine HCl followed by a supplemental half-dose of 62.5 mg of midomafetamine HCl
DRUG	Lactose placebo pill	125 mg followed by a supplemental half-dose of 62.5 mg
BEHAVIORAL	Therapy	Non-directive therapy provided by a team of two co-therapists

Timeline

• Start date: 2004-03-12
• Primary completion: 2008-05-02
• Completion: 2010-06-21
• First posted: 2004-08-25
• Last updated: 2025-06-06
• Results posted: 2021-10-25

Locations

1 site across 1 country: United States