MedTrace Logo

Study of Safety and Effects of MDMA-assisted Psychotherapy for Treatment of PTSD (Canada)

NCT03485287 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2025-06-10

Study results available
· View outcomes & findings →

Summary

The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective at reducing PTSD symptoms in people 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 HCl

Three sessions of MDMA-assisted therapy with flexible dose of midomafetamine HCl from 100 to 125 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later

BEHAVIORAL

Manualized therapy

Non-directive therapy

Sponsors & Collaborators

Principal Investigators

  • Michael Mithoefer · 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
2018-03-13
Primary Completion
2019-06-04
Completion
2019-06-04
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

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 NCT03485287 on ClinicalTrials.gov