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

NCT03485287 | Completed Phase 2 Results FDA Drug

• 1 other identifier: MP-17
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief 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

Posttraumatic Stress Disorder

Keywords

PTSD; MDMA; Therapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Primary Endpoint in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score

  The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.

  Baseline (Visit 3) to Primary Endpoint (Visit 19,18 weeks post enrollment)

Secondary Outcomes (1)

• Change From Baseline to Primary Endpoint in Sheehan Disability Scale (SDS for PTSD for MAPS) Total Score

  Baseline (Visit 3) to Primary Endpoint (Visit 19, 18 weeks post-enrollment)

Study Arms (1)

MDMA-assisted therapy

EXPERIMENTAL

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

Drug: Midomafetamine HCl; Behavioral: Manualized therapy

Interventions

Midomafetamine HCl DRUG

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

Also known as: 3,4-methylenedioxymethamphetamine, MDMA, MDMA HCl, midomafetamine

MDMA-assisted therapy

Manualized therapy BEHAVIORAL

Non-directive therapy

MDMA-assisted therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are at least 18 years old
• Are fluent in speaking and reading the predominantly used or recognized language of the study site
• Agree to have study visits recorded, including Experimental Sessions, Independent Rater assessments, and non-drug psychotherapy sessions
• Must provide a contact (relative, spouse, close friend or other caregiver) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.
• Must agree to inform the investigators within 48 hours of any medical conditions and procedures.
• If of childbearing potential, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 days after the last Experimental Session.
• Must not participate in any other interventional clinical trials during the duration of the study,
• Must be willing to remain overnight at the study site after each Experimental Session and be driven home after, and commit to medication dosing, therapy, and study procedures

You may not qualify if:

• Are not able to give adequate informed consent
• Have uncontrolled hypertension
• Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 milliseconds \[ms\] corrected by Bazett's formula)
• Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
• Have evidence or history of significant medical disorders
• Have symptomatic liver disease
• Have history of hyponatremia or hyperthermia
• Weigh less than 48 kilograms (kg)
• Are pregnant or nursing, or are of childbearing potential and are not practicing an effective means of birth control.
• Meet DSM-5 criteria for active substance use disorder for any substance other than caffeine or nicotine
• Have used Ecstasy (material represented as containing MDMA) more than 10 times within the last 10 years or at least once within 6 months of the first Experimental Session; or have previously participated in a MAPS or Lykos-sponsored MDMA clinical trial.

Sponsors & Collaborators

• Lykos Therapeutics: lead

Study Sites (2)

British Columbia Centre on Substance Abuse

Vancouver, British Columbia, V64 1H, Canada

Location

Dr. Simon Amar, LLC

Montreal, Quebec, H2W 1Y9, Canada

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

N-Methyl-3,4-methylenedioxyamphetamine

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Limitations and Caveats

This was an open-label trial with no placebo comparator in a small sample size (n=4).

Results Point of Contact

• Title: Study Director
• Organization: Lykos Therapeutics

trialdata@lykospbc.com

877-627-7722

Study Officials

• Michael Mithoefer

  MAPS Public Benefit Corp.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Three sessions of MDMA-assisted therapy with flexible dose of MDMA (100 to 125 mg with optional supplemental half-dose)

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: April 2, 2018
• Study Start: March 13, 2018
• Primary Completion: June 4, 2019
• Study Completion: June 4, 2019
• Last Updated: June 10, 2025
• Results First Posted: July 1, 2021

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data and study-related documents will be available when all participants have completed the study
• Access Criteria: Interested persons should correspond with the central contact for study.

Locations

CA (2)