RecruitingPhase 2NCT05790239

MDMA-Assisted Therapy for Veterans With Moderate to Severe Post Traumatic Stress Disorder

A Randomized, Double-Blind, Single-Site Phase II 2-Arm Study to Compare the Safety and Preliminary Efficacy of Manualized MDMA-Assisted Therapy to Low Dose D-Amphetamine Assisted Therapy in Veterans For The Treatment of Moderate to Severe PTSD


Sponsor

Stephen Robert Marder

Enrollment

40 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This randomized, double-blind, single-site phase II 2-arm study will investigate the safety and preliminary efficacy of MDMA-assisted therapy compared with low dose d-amphetamine-assisted therapy on the severity of PTSD symptoms in participants aged 18 years and older with PTSD of at least moderate severity.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing MDMA-assisted therapy for U.S. military veterans with moderate to severe PTSD. MDMA (commonly known as "ecstasy") — when used in a carefully controlled therapeutic setting with trained therapists — may help people process traumatic memories more effectively than talk therapy alone. **You may be eligible if...** - You are a U.S. veteran enrolled at a VA Healthcare Center in the Greater Los Angeles area - You meet diagnostic criteria for PTSD with symptoms lasting at least 6 months - You speak and read English fluently - You weigh at least 45 kg (about 100 lbs) - You can identify a support person to stay with you after therapy sessions if needed - You may have well-controlled, treated high blood pressure (with additional screening) **You may NOT be eligible if...** - You have active, uncontrolled cardiovascular disease or significant heart problems - You have certain psychiatric conditions that could make MDMA unsafe (such as active psychosis or unstable bipolar disorder) - You are currently taking medications that interact dangerously with MDMA (e.g., MAOIs, lithium) - You are pregnant or planning to become pregnant - You have a history of serious liver disease 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

Initial doses per Experimental Session include 68 mg or 100 mg MDMA (equivalent to 80 mg or 120 mg MDMA HCl), followed 1.5 to 2 hours later by a supplemental dose of 34 mg or 50 mg MDMA (equivalent to 40 mg or 60 mg MDMA HCl).

DRUGd-amphetamine

Initial dose per experimental session will be 5 mg or 10 mg d-amphetamine, followed 1.5 to 2 hours later by supplemental dose of 2.5 mg or 5 mg d-amphetamine.

BEHAVIORALTherapy

Participants assigned to MDMA and d-amphetamine will undergo a therapeutic approach, which is detailed in the MDMA-Assisted Therapy Treatment Manual and administered by MAPS-trained therapists. In brief, this therapy is guided by the subject's own recollections of traumatic events. The subject and two therapists provide a comfortable and supportive environment and allow the subject to guide the discussion. Subjects are encouraged to experience and express fear, anger, and grief with less likelihood of feeling overwhelmed by these emotions. MDMA seems to engender internal awareness that even painful feelings that arise are an important part of the therapeutic process. In addition, feelings of empathy, love, and deep appreciation often emerge, along with a clearer perspective of the trauma as a past event, a more accurate perspective about its significance, and a heightened awareness of the support and safety that exists in the present.


Locations(2)

VA Greater Los Angeles Healthcare System, Westwood campus

Los Angeles, California, United States

West Los Angeles Veteran Affairs

Los Angeles, California, United States

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NCT05790239


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