← Back to Search

Group MDMA Therapy for PTSD (Group-MVP Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Portland VA Research Foundation, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline - 3 months from first experimental session
Awards & highlights

Group-MVP Trial Summary

This trial assesses the feasibility & safety of MDMA-assisted group therapy for PTSD in veterans. Up to 18 participants will receive therapy sessions in 3 cohorts.

Who is the study for?
This trial is for U.S. Military Veterans aged 18 or older with PTSD who can swallow pills, agree to recorded study visits, and commit to the study's procedures. Participants must not be in other trials, have a reliable emergency contact, and if capable of pregnancy, use contraception and provide negative tests.Check my eligibility
What is being tested?
The trial explores MDMA-assisted group therapy for treating PTSD in veterans. It involves three cohorts of six participants each undergoing therapy sessions together without random assignment to different treatments (open-label).See study design
What are the potential side effects?
While specific side effects are not listed here, MDMA can typically cause anxiety, headache, nausea, insomnia, fatigue after use (come-down), muscle tension or jaw clenching during the experience.

Group-MVP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline - 3 months from first experimental session
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline - 3 months from first experimental session for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in CAPS-5 Total Severity Score
Secondary outcome measures
Change in Sheehan Disability Scale (SDS)

Group-MVP Trial Design

1Treatment groups
Experimental Treatment
Group I: MDMA-assisted group therapyExperimental Treatment2 Interventions
Four Preparatory Sessions, two MDMA Sessions, and four Integrative Sessions following each MDMA Session.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MDMA
2001
Completed Phase 2
~390
Group Therapy
2005
Completed Phase 2
~930

Find a Location

Who is running the clinical trial?

Steven & Alexandra Cohen FoundationOTHER
6 Previous Clinical Trials
206 Total Patients Enrolled
Portland VA Research Foundation, IncLead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research study provide the opportunity for seniors to participate?

"The minimum age for enrollment in this medical trial is 18 years old, while the maximum acceptable age of participation is 64."

Answered by AI

Is participation in this study open to qualified individuals at the present time?

"Affirmative. Information on clinicaltrials.gov testifies that this trial is still recruiting subjects; it was initially posted on October 1st 2023 and revised most recently on October 2nd of the same year. 18 participants are necessary from one medical centre to complete the study requirements."

Answered by AI

How many individuals may partake in this investigation?

"Affirmative. According to clinicaltrials.gov, this research is currently recruiting participants and was initially posted on October 1st 2023. The most recent edit occurred on the 2nd of October in that same year. 18 individuals must be sourced from a single site for this experiment to go ahead."

Answered by AI

How can I join this clinical experiment?

"This medical experiment requires 18 participants between the ages of majority and 64 with post-traumatic stress disorder, who meet a variety of criteria. These include being veterans in the United States Military, possessing fluency in the language used at their study site, avowing to take medication as per instructions and attend all therapy sessions, agreeing for visits to be recorded including MDMA usage if applicable, nominating an individual that can reach them should they become unreachable or suicidal, informing investigators within 48 hours about any new illnesses or procedures undertaken by them and undergoing pregnancy tests before each experimental session. Additionally women must commit to using contraception during 10 days following the last experimental session"

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
~12 spots leftby Jul 2025