Dose Optimization of MDMA-Assisted Therapy for PTSD

NCT06418178 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 171633
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This open label, within-subjects dose optimization trial will investigate the optimal number of MDMA-Assisted Therapy treatment cycles (i.e., one MDMA session and three integration sessions) in a sample of U.S. veterans with PTSD. Participants will complete from one to five cycles of MDMA-AT.

Conditions

Posttraumatic Stress Disorder

Keywords

Posttraumatic Stress Disorder; MDMA-Assisted Therapy; Dose Optimization; Veterans

Outcome Measures

Primary Outcomes (1)

• PTSD Checklist for DSM-5 (PCL-5)

  The PCL-5 is a 20-item self-report questionnaire in which respondents indicate the presence and severity of PTSD symptoms per DSM-5. Participants indicate how much distress they have experienced due to each symptom on a five-point Likert-type scale (1=Not at all to 5=Extremely).

  From Baseline to Outcome Site Visit (up to ~27 weeks for participants who complete all five treatment cycles)

Secondary Outcomes (1)

• Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

  From Pre-treatment Psychological Evaluation to Post-treatment Psychological Evaluation (up to ~28 weeks for participants who complete all five treatment cycles)

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Open label, within-subjects treatment arm. Participants receive 120mg + optional 60mg supplement. There will be from one to five dosing sessions that occur three to five weeks apart. Each dosing session is followed by three integration psychotherapy sessions.

Drug: Midomafetamine; Behavioral: Psychotherapy

Interventions

Midomafetamine DRUG

One to five MDMA-assisted therapy sessions, each followed by three non-drug psychotherapy sessions (see behavioral intervention below)

Also known as: MDMA, 3,4-methylenedioxymethamphetamine

Treatment Arm

Psychotherapy BEHAVIORAL

Standardized psychotherapy performed by therapy team

Treatment Arm

Eligibility Criteria

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

You may qualify if:

• Are a U.S. military veteran at least 18 years old.
• Are able to provide written, informed consent.
• Are able to swallow pills.
• Agree to have study visits recorded, including Experimental Sessions, psychological assessments, and non-drug therapy sessions.
• Must provide a contact who is willing and able to be reached by the investigators in the event of a participant becoming unwell or unreachable.
• If able to become pregnant, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate contraceptive methods.
• Must have a current PTSD diagnosis at screening and baseline.
• Must not participate in any other interventional clinical trials for the duration of the study.
• Must commit to medication dosing, therapy, and all study procedures.

You may not qualify if:

• Are not able to give adequate informed consent.
• Have a history of any medical condition, or any significant clinical finding on screening tests, that could make receiving a sympathomimetic drug harmful.
• Have uncontrolled hypertension.
• Have evidence or history of significant medical or psychiatric disorders.
• Have symptomatic liver disease.
• Have history of hyponatremia or hyperthermia.
• Weigh less than 48 kilograms (kg).
• Unable or unwilling to safely taper off prohibited psychiatric medication.
• Abusing illegal drugs or alcohol.
• Have received Electroconvulsive Therapy (ECT) or ketamine therapy within 12 weeks of enrollment.
• Are pregnant or nursing or are able to become pregnant and are not practicing an effective means of contraception.

Sponsors & Collaborators

• Bronx VA Medical Center: lead

Study Sites (1)

James J. Peters VA Medical Center

The Bronx, New York, 10468, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

N-Methyl-3,4-methylenedioxyamphetamine; Psychotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Behavioral Disciplines and Activities

Study Officials

• Rachel Yehuda, PhD

  James J. Peters VA Medical Center

  PRINCIPAL INVESTIGATOR

• Amy Lehrner, PhD

  James J. Peters VA Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Lehrner, PhD

CONTACT

718-584-9000; Amy.Lehrner@va.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mental Health Patient Care Center Director

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 17, 2024
• Study Start: June 3, 2025
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)