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Open Label Multi-Site Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD

NCT03282123 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-06-05

Study results available
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Summary

The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people diagnosed with at least severe PTSD.

The main question it aims to answer is: Do three open-label sessions of MDMA-assisted therapy reduce PTSD symptoms?

Participants will receive three non-drug preparatory sessions followed by three sessions of MDMA-assisted therapy. Each MDMA-assisted therapy session is followed by three non-drug integrative therapy sessions.

Conditions

Interventions

DRUG

Midomafetamine

80 to 120 mg MDMA

BEHAVIORAL

Manualized therapy

Non-directive therapy conducted during MDMA-assisted therapy session

Sponsors & Collaborators

Principal Investigators

  • Michael C Mithoefer, MD · MAPS Public Benefit Corp.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-16
Primary Completion
2019-08-10
Completion
2019-08-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT03282123 on ClinicalTrials.gov