MDMA-Assisted Therapy for PTSD

(MPVA6 Trial)

Overseen By Recruitment 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

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.

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.

Treatment Details

Interventions

• MDMA (Psychedelic)
• Psychotherapy (Behavioral Intervention)

Trial Overview The 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

Group I: Two sessions of MDMA-assisted therapy Active Control 2 Interventions

Two experimental sessions of MDMA-assisted therapy

Group II: Three sessions of MDMA-assisted therapy Active Control 2 Interventions

Three experimental sessions of MDMA-assisted therapy

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+