MDMA-Assisted Therapy for PTSD
(MPVA6 Trial)
RY
RO
Overseen ByRecruitment Officer
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: MAPS Public Benefit Corporation
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This trial tests the effectiveness of different numbers of MDMA-assisted therapy sessions in U.S. military veterans with moderate to severe PTSD. MDMA helps patients feel more open and comfortable during therapy, aiding in the processing of traumatic memories. MDMA-assisted psychotherapy began in the 1980s but was shelved due to public health concerns.
Research Team
RY
Rachel Yehuda
Principal Investigator
Icahn School of Medicine at Mount Sinai
Eligibility Criteria
This trial is for U.S. military veterans aged 18 or older with moderate chronic PTSD. Participants must not be in other trials, able to swallow pills, and fluent in the study site's language. They need a contact person in case of emergencies and agree to recorded sessions and overnight stays post-treatment.Inclusion Criteria
You are not participating in any other interventional clinical trials during the duration of the study.
I am 18 years old or older.
I can swallow pills.
See 14 more
Exclusion Criteria
I have had low sodium levels or very high body temperature in the past.
You have a history of serious medical conditions or currently have a significant medical problem.
I have symptoms caused by liver problems.
See 7 more
Treatment Details
Interventions
- MDMA (Psychedelic)
- Psychotherapy (Behavioral Intervention)
Trial OverviewThe study compares the effectiveness of two versus three active MDMA-assisted psychotherapy sessions for treating PTSD in veterans. It's an open-label, randomized trial where participants will receive either two or three doses of MDMA during therapy at a VA clinic.
Participant Groups
2Treatment groups
Active Control
Group I: Two sessions of MDMA-assisted therapyActive Control2 Interventions
Two experimental sessions of MDMA-assisted therapy
Group II: Three sessions of MDMA-assisted therapyActive Control2 Interventions
Three experimental sessions of MDMA-assisted therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
MAPS Public Benefit Corporation
Lead Sponsor
Trials
30
Recruited
900+
Lykos Therapeutics
Lead Sponsor
Trials
32
Recruited
960+
Multidisciplinary Association for Psychedelic Studies
Lead Sponsor
Trials
40
Recruited
1,200+