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

NCT03282123 | Completed Phase 2 Results FDA Drug

• 1 other identifier: MP-16
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 12

Brief 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

PTSD

Keywords

MDMA; methylenedioxymethamphetamine; therapy; midomafetamine

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Visit 19 in CAPS-5 Total Severity Scores

  The Clinician-Administered PTSD Scale for DSM-V (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. 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 to 18 weeks post-enrollment

Secondary Outcomes (1)

• Change From Baseline to Visit 19 in Adapted SDS Total Score

  Baseline to 18 weeks post-enrollment

Study Arms (1)

MDMA-assisted therapy

EXPERIMENTAL

Three sessions of MDMA-assisted therapy with flexible dose of midomafetamine HCl from 80 to 120 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later

Drug: Midomafetamine; Behavioral: Manualized therapy

Interventions

Midomafetamine DRUG

80 to 120 mg MDMA

Also known as: 3,4-methylenedioxymethamphetamine, MDMA

MDMA-assisted therapy

Manualized therapy BEHAVIORAL

Non-directive therapy conducted during MDMA-assisted therapy session

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
• Meet DSM-5 Criteria for Severe PTSD

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.

Sponsors & Collaborators

• Lykos Therapeutics: lead

Study Sites (12)

New School Research LLC

North Hollywood, California, 91601, United States

Location

San Francisco Insight and Integration Center

San Francisco, California, 94114, United States

Location

University of California San Francisco

San Francisco, California, 94122, United States

Location

Aguazul-Blue Water Inc.

Boulder, Colorado, 80302, United States

Location

Wholeness Center

Fort Collins, Colorado, 80525, United States

Location

University of Connecticut

Farmington, Connecticut, 06030, United States

Location

Ray Worthy Psychiatry LLC

New Orleans, Louisiana, 70123, United States

Location

Trauma Research Foundation

Brookline, Massachusetts, 02446, United States

Location

New York University

New York, New York, 10016, United States

Location

Affective Care

New York, New York, 10024, United States

Location

Zen Therapeutic Solutions, LLC

Mt. Pleasant, South Carolina, 29464, United States

Location

University of Wisconsin at Madison

Madison, Wisconsin, 53705, United States

Location

Related Publications (1)

• Christie D, Yazar-Klosinski B, Nosova E, Kryskow P, Siu W, Lessor D, Argento E. MDMA-assisted therapy is associated with a reduction in chronic pain among people with post-traumatic stress disorder. Front Psychiatry. 2022 Nov 3;13:939302. doi: 10.3389/fpsyt.2022.939302. eCollection 2022.

  PMID: 36405923 DERIVED

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

Results Point of Contact

• Title: Study Director
• Organization: Lykos Therapeutics

trialdata@lykospbc.com

877-627-7722

Study Officials

• Michael C Mithoefer, MD

  MAPS Public Benefit Corp.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: This study will be open label
• 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 (80 to 120 mg with optional supplemental half-dose)

Study Record Dates

• First Submitted: September 11, 2017
• First Posted: September 13, 2017
• Study Start: November 16, 2017
• Primary Completion: August 10, 2019
• Study Completion: August 10, 2019
• Last Updated: June 5, 2025
• Results First Posted: July 29, 2021

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)