MDMA-Assisted Therapy for Post-Traumatic Stress Disorder

(DosOp Trial)

Overseen By Amy Lehrner, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Bronx VA Medical Center

Must not be taking: Psychiatric medications

Disqualifiers: Hypertension, Liver disease, Drug abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 3-5 weeks per cycle, up to 25 weeks total

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This open label, within-subjects dose optimization trial will investigate the optimal number of MDMA-Assisted Therapy treatment cycles (i.e., one MDMA session and three integration sessions) in a sample of U.S. veterans with PTSD. Participants will complete from one to five cycles of MDMA-AT.

Who Is on the Research Team?

Rachel Yehuda, PhD

Principal Investigator

James J. Peters VA Medical Center

Amy Lehrner, PhD

Principal Investigator

James J. Peters VA Medical Center

Are You a Good Fit for This Trial?

This trial is for U.S. veterans with PTSD who can consent, swallow pills, and agree to recorded study visits. Participants need a contact person for emergencies, must not be in other trials, commit to the therapy and study procedures. If they can become pregnant, they must test negative for pregnancy and use contraception.

Inclusion Criteria

I can sign and understand the consent form.

I can swallow pills.

I agree to have all study visits and sessions recorded.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Enrollment

Enrollment and medication tapering period (if needed) followed by psychological assessment and Enrollment Confirmation, collection of biomarker blood samples

2-4 weeks

Treatment

3 Preparatory sessions; one to five Experimental Sessions, each followed by 3 non-drug Integrative Sessions and a follow-up visit with study therapists

3-5 weeks per cycle, up to 25 weeks total

Post-treatment

Psychological Evaluation, biomarker blood samples, study termination visit

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MDMA-Assisted Therapy
• Midomafetamine

Trial Overview The trial is testing how many cycles of MDMA-Assisted Therapy (one MDMA session plus three integration sessions) are optimal for treating PTSD in veterans. Each participant may undergo up to five treatment cycles to determine the best number.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 2 Interventions

Open label, within-subjects treatment arm. Participants receive 120mg + optional 60mg supplement. There will be from one to five dosing sessions that occur three to five weeks apart. Each dosing session is followed by three integration psychotherapy sessions.

Who Is Running the Clinical Trial?

Bronx VA Medical Center

Lead Sponsor

Trials

22

Recruited

1,300+