MDMA-Assisted Psychotherapy for PTSD
(VALLMDMA_001 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This will be a single-site, open-label phase 2 study designed to test the feasibility of administering MDMA in conjunction with psychotherapy for combat-related treatment-resistant PTSD in US military veterans currently enrolled in VA. MDMA will be given in conjunction with structured psychotherapy in three single-dose psychotherapy sessions in a hospital setting over the course of 12 weeks, along with preparatory and integration psychotherapy sessions in-between each active-dose session. The overall objective of this study is to evaluate the risks, benefits, and feasibility of MDMA used in conjunction with manualized psychotherapy, on reduction of symptoms, or remission of PTSD, as evaluated by standard clinical measures, in a VA Healthcare System.The primary outcome measure for the study is the Clinician-Administered PTSD Scale (CAPS-5), a semi-structured interview used in the majority of clinical trials for PTSD, which will be assessed at baseline, primary endpoint, and at the long-term 12-month follow-up visit. Secondary safety and efficacy measures will also be collected.The planned duration of this study is 1-3 years, with each active treatment period lasting approximately 12 weeks, along with a long-term follow-up 12 months after the last active-drug session.
Who Is on the Research Team?
Shannon Remick, MD
Principal Investigator
Staff Psychiatrist
Are You a Good Fit for This Trial?
This trial is for US military veterans aged 18-55 with combat-related PTSD that hasn't improved after treatment, enrolled in VA healthcare. They must be generally healthy, not on psychiatric meds (or willing to stop them safely), and agree to avoid alcohol before sessions and certain medications during the study. Pregnant women or those at serious suicide risk are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preparatory Psychotherapy
Three preparatory psychotherapy sessions spaced approximately one week apart
Experimental Treatment
Three single-dose MDMA-assisted psychotherapy sessions with integrative follow-up sessions
Primary Endpoint Assessment
Assessment of primary endpoint 2 months after the last experimental session
Long-term Follow-up
Assessment of long-term effects 12 months after the last MDMA session
What Are the Treatments Tested in This Trial?
Interventions
- 3,4-methylenedioxymethamphetamine (MDMA)
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Loma Linda Health Care System
Lead Sponsor
Lykos Therapeutics
Collaborator
Multidisciplinary Association for Psychedelic Studies
Collaborator