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MDMA-Assisted Psychotherapy in People With Posttraumatic Stress Disorder

NCT00090064 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-06-06

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Michael Mithoefer, MD · Private Practice

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-12
Primary Completion
2008-05-02
Completion
2010-06-21

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00090064 on ClinicalTrials.gov