RecruitingPhase 3NCT06117306

MDMA-assisted Massed Prolonged Exposure for PTSD


Sponsor

Healing Breakthrough

Enrollment

20 participants

Start Date

Oct 25, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study tests MDMA-assisted massed prolonged exposure (MPE) therapy for veterans with PTSD. MDMA (the active compound in ecstasy) is given alongside an intensive form of trauma-focused therapy to help veterans process traumatic memories more effectively. Sessions are compressed into a shorter time frame ("massed" means intensive). **You may be eligible if:** - You are a veteran between 18 and 64 years old - You meet diagnostic criteria for PTSD (CAPS-5 score of 25 or higher) - You speak and read English fluently - You are willing to have sessions recorded and reviewed - You have a contact person who can drive you home after MDMA sessions - You can swallow pills **You may NOT be eligible if:** - You have certain heart, liver, or kidney conditions - You have a history of psychosis or bipolar disorder type I - You have active suicidal intent - You have certain drug interactions or medical contraindications - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG3,4 Methylenedioxymethamphetamine

1 MDMA session

BEHAVIORALProlonged Exposure

12 90-minute PE sessions; initial two sessions both occurring during the first treatment visit, third and fourth sessions occurring during the MDMA session, and the remaining sessions occurring daily or every other day


Locations(1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States

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NCT06117306


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