RecruitingPhase 3

MDMA-assisted Massed Prolonged Exposure for PTSD

United States20 participantsStarted 2024-10-25

Plain-language summary

The overall objective of this study is to pilot the VASDHS-adapted Emory MDMA-PE Protocol (aE-MDMA-PE) and assess the effect on clinician-rated PTSD symptoms in veterans who receive different doses of MDMA.

Who can participate

Age range18 Years – 64 Years

SexALL

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Inclusion criteria

✓. Be a veteran (age 18-64 years old) who meets criteria for PTSD on the CAPS-5 (severity ≥ 25).
✓. Be fluent in speaking and reading English.
✓. Are willing to commit to medication dosing, therapy sessions, follow-up sessions, completing evaluation instruments, and all necessary telephone contact
✓. Be able to swallow pills.
✓. Agree to have study visits audio and/or video recorded, including MDMA session, assessments, and PE sessions, and aware that Independent Rater assessments for PE sessions will occur.
✓. Have a contact able to drive the participant home after the MDMA session.
✓. Provide a contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.
✓. Agree to inform the investigators within 48 hours of any new medical conditions or procedures.

Exclusion criteria

✕. Are not able to give adequate, written informed consent.
✕. Are currently engaged in compensation and pension (C\&P) litigation whereby financial gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders.
✕. Are likely, in the investigator's opinion and via assessment period, to be re- exposed to their index trauma or other significant trauma, lack social support, or lack a stable living situation.
✕. Have used Ecstasy (material represented as containing MDMA) or have participated in an MDMA clinical trial.
✕. Have a positive screen for amphetamine or cocaine.
✕. Have any current problem which, in the clinical opinion of the investigator and study physician, might interfere with participation due to it impacting the patient's safety and/or ability to participate in the protocol.
✕. Have hypersensitivity to any ingredient of the IMP (Investigational Medicinal Product).
✕. Have received Electroconvulsive Therapy (ECT) within 12 weeks of enrollment.

What they're measuring

Clinician-rated PTSD symptoms

Timeframe: Baseline - 4-months post-treatment

Trial details

NCT IDNCT06117306

SponsorHealing Breakthrough

Sponsor typeUNKNOWN

Study typeINTERVENTIONAL

Primary completion2027-08-31

Contact for this trial

Leslie A Morland, Psy.D.

858-226-5765 Leslie.Morland@va.gov

View on ClinicalTrials.gov More Post-Traumatic Stress Disorder trials