RECRUITING

Dose Optimization of MDMA-Assisted Therapy for PTSD

Conditions

Posttraumatic Stress Disorder MDMA-Assisted Therapy Dose Optimization Veterans

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Dose Optimization Study of MDMA-Assisted Therapy for PTSD in U.S. Veterans

Quick Facts

Study Start:2025-06-03

Study Completion:2029-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06418178

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Are a U.S. military veteran at least 18 years old. 2. Are able to provide written, informed consent. 3. Are able to swallow pills. 4. Agree to have study visits recorded, including Experimental Sessions, psychological assessments, and non-drug therapy sessions. 5. 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. 6. 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. 7. Must have a current PTSD diagnosis at screening and baseline. 8. Must not participate in any other interventional clinical trials for the duration of the study. 9. Must commit to medication dosing, therapy, and all study procedures.	1. Are not able to give adequate informed consent. 2. Have a history of any medical condition, or any significant clinical finding on screening tests, that could make receiving a sympathomimetic drug harmful. 3. Have uncontrolled hypertension. 4. Have evidence or history of significant medical or psychiatric disorders. 5. Have symptomatic liver disease. 6. Have history of hyponatremia or hyperthermia. 7. Weigh less than 48 kilograms (kg). 8. Unable or unwilling to safely taper off prohibited psychiatric medication. 9. Abusing illegal drugs or alcohol. 10. Have received Electroconvulsive Therapy (ECT) or ketamine therapy within 12 weeks of enrollment. 11. Are pregnant or nursing or are able to become pregnant and are not practicing an effective means of contraception.

Inclusion Criteria

Exclusion Criteria

1. Are a U.S. military veteran at least 18 years old.
2. Are able to provide written, informed consent.
3. Are able to swallow pills.
4. Agree to have study visits recorded, including Experimental Sessions, psychological assessments, and non-drug therapy sessions.
5. 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.
6. 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.
7. Must have a current PTSD diagnosis at screening and baseline.
8. Must not participate in any other interventional clinical trials for the duration of the study.
9. Must commit to medication dosing, therapy, and all study procedures.

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

Contacts and Locations

Study Contact

Amy Lehrner, PhD

CONTACT

718-584-9000

Amy.Lehrner@va.gov

Principal Investigator

Rachel Yehuda, PhD

PRINCIPAL_INVESTIGATOR

James J. Peters VA Medical Center

Amy Lehrner, PhD

PRINCIPAL_INVESTIGATOR

James J. Peters VA Medical Center

Study Locations (Sites)

James J. Peters VA Medical Center

Bronx, New York, 10468

United States

Collaborators and Investigators

Sponsor: Bronx VA Medical Center

Rachel Yehuda, PhD, PRINCIPAL_INVESTIGATOR, James J. Peters VA Medical Center
Amy Lehrner, PhD, PRINCIPAL_INVESTIGATOR, James J. Peters VA Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-03

Study Completion Date2029-10

Study Record Updates

Study Start Date2025-06-03

Study Completion Date2029-10

Terms related to this study

Keywords Provided by Researchers

Posttraumatic Stress Disorder
MDMA-Assisted Therapy
Dose Optimization
Veterans

Additional Relevant MeSH Terms

Posttraumatic Stress Disorder