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A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP2)

NCT04077437 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2025-06-06

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 with at least moderate PTSD.

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

Researchers will compare three sessions of MDMA-assisted therapy with an initial dose of 80 to 120 mg to three sessions of placebo with therapy.

Participants will undergo three preparatory sessions without any study drug, followed by three MDMA-assisted therapy or placebo with therapy sessions. Each medication session will be followed by three integrative therapy sessions without study drug.

Conditions

Interventions

BEHAVIORAL

Therapy

Standardized non-directive therapy performed by therapist team.

DRUG

Midomafetamine

Administration of 80 to 120 mg midomafetamine HCl, followed by a supplemental half-dose 1.5 to 2 hrs after the initial dose of 40 or 60 mg, respectively, during three sessions of MDMA-assisted psychotherapy.

DRUG

Placebo

Administration of placebo with therapy during three experimental sessions

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-02
Primary Completion
2022-10-30
Completion
2022-11-02
FDA Drug
Yes

Countries

  • United States
  • Israel

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 NCT04077437 on ClinicalTrials.gov