MDMA + Psilocybin for PTSD

(PAM-VET Trial)

Overseen By Chloe Ford, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Johns Hopkins University

Must not be taking: Antidepressants, MAOIs, Bupropion, others

Disqualifiers: Schizophrenia, Bipolar, Alcohol use, others

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

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess the safety and effectiveness of co-administered MDMA and psilocybin in military Veterans with a diagnosis of Posttraumatic Stress Disorder (PTSD).

Research Team

Brandon Weiss, PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

Military Veterans aged 21+ with confirmed PTSD lasting over 6 months, a CAPS-5 score of >=28, and stable psychotherapy. Participants must be medically stable, not at high risk for suicide, able to swallow pills, weigh between 40kg-120kg, have at least high school education or equivalent, and agree to drug restrictions. Exclusions include certain medical conditions or histories; recent suicidal ideation; unstable medication doses; illicit drug/alcohol use; pregnancy/nursing.

Inclusion Criteria

I have been in stable psychotherapy for at least 2 months.

Must be medically stable as determined by screening for medical problems

Must be judged by study team clinicians to be at low acute risk for suicidality

Exclusion Criteria

Specific medical history exclusions

Specific medical history exclusions

Specific medical history exclusions

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single experimental dose of co-administered MDMA and psilocybin, followed by a second single-blind dosing session approximately 1.5 months later

6 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of PTSD symptoms and adverse events

33 weeks

Treatment Details

Interventions

• MDMA
• Psilocybin

Trial Overview The trial is testing the safety and effectiveness of MDMA combined with psilocybin in treating PTSD in military veterans. The study involves administering these substances under controlled conditions to evaluate their therapeutic potential compared to current treatment standards.

Participant Groups

Group I: Experimental MDMA + psilocybin (exact dosage not disclosed) Experimental Treatment 2 Interventions

MDMA will be given initially, followed by psilocybin 30 minutes later.

Group II: Comparator MDMA + psilocybin (exact dosage not disclosed) Active Control 2 Interventions

MDMA will be given initially, followed by psilocybin 30 minutes later.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Gracias Family Foundation

Collaborator