Trial Summary
What is the purpose of this trial?This trial is testing two treatments for adults with moderate to severe PTSD. One treatment uses MDMA to help patients feel more comfortable during therapy, and the other uses a small dose of d-amphetamine to help them stay focused. The goal is to see if these treatments can reduce PTSD symptoms. MDMA has recently been shown as a novel therapeutic agent with promising results in the treatment of PTSD.
Eligibility Criteria
This trial is for veterans in the Greater Los Angeles area who have moderate to severe PTSD. Participants must be fluent in English, able to use effective contraception if applicable, and willing to have therapy sessions recorded. They should not be abusing drugs or involved in other clinical studies.Inclusion Criteria
A person able to be pregnant (PABP) must use a highly effective contraceptive method
At Screening, meet DSM-5 criteria for current PTSD with a symptom duration of at least 6 months
My high blood pressure is well-managed with medication.
+8 more
Exclusion Criteria
Current enrollment in any other clinical study involving an investigational study treatment or any other type of medical research, unless approved by the study clinician
Have evidence or history of significant medical or psychiatric disorders
Are abusing illegal drugs
+2 more
Participant Groups
The study compares MDMA-assisted therapy with low dose d-amphetamine-assisted therapy for PTSD symptoms. It's a phase II trial where participants are randomly assigned to one of the two treatments without knowing which one they're receiving.
2Treatment groups
Experimental Treatment
Active Control
Group I: MDMA-Assisted TherapyExperimental Treatment2 Interventions
Participants will receive a flexible divided-dose of MDMA plus therapy at Experimental Sessions.
Group II: Low Dose D-Amphetamine Assisted TherapyActive Control2 Interventions
Participants will receive a flexible divided dose plus therapy at Experimental Sessions.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
VA Greater Los Angeles Healthcare System, Westwood campusLos Angeles, CA
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Who Is Running the Clinical Trial?
Stephen Robert MarderLead Sponsor