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

PHASE2RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

March 1, 2025

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2026

Conditions
Post Traumatic Stress Disorder
Interventions
DRUG

3,4-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).

DRUG

d-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.

BEHAVIORAL

Therapy

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.

Trial Locations (2)

90073

NOT_YET_RECRUITING

VA Greater Los Angeles Healthcare System, Westwood campus, Los Angeles

90095

RECRUITING

West Los Angeles Veteran Affairs, Los Angeles

All Listed Sponsors
lead

Stephen Robert Marder

FED