MDMA-Assisted Psychotherapy for PTSD
Trial Summary
What is the purpose of this trial?
This is an add-on substudy to an already-approved clinical trial "A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD" (ClinicalTrials.gov Identifier: NCT03537014) which is to be a phase 3 clinical trial studying the efficacy of MDMA-Assisted Psychotherapy for Post Traumatic Stress Disorder. The parent study has been approved by Copernicus Group IRB and is being run by the MAPS Public Benefit Corporation, and is a randomized controlled trial comparing the clinical efficacy of MDMA-assisted psychotherapy to Placebo-assisted psychotherapy. The parent study will recruit participants with Post Traumatic Stress Disorder and involves 20 total study visits over the course of 18 weeks including 3 preparatory psychotherapy visits plus 3 separate treatment sessions involving psychotherapy plus the administration of MDMA vs. placebo and 3 follow up psychotherapy visits after each treatment session.This substudy adds on the collection of saliva in a salivary DNA collection kit at baseline and after treatment to the parent study clinical trail so as to assess whether the MDMA-Assisted Psychotherapy exerts influence on the epigenetic regulation of stress-associated genes as assessed in the salivary epithelial and white blood cells of the research participants. We aim to further assess whether any such changes are correlated with improvements in PTSD symptoms.
Research Team
Rael Cahn, MD, PhD
Principal Investigator
University of Southern California
Eligibility Criteria
This trial is for individuals with Post-Traumatic Stress Disorder (PTSD) who are already participating in a Phase 3 study of MDMA-Assisted Psychotherapy. Participants will provide saliva samples to explore if the therapy affects stress-related genes.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Preparatory Psychotherapy
Participants undergo 3 preparatory psychotherapy visits before treatment sessions
Treatment
Participants receive MDMA or placebo during 3 treatment sessions with psychotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment, including 3 follow-up psychotherapy visits
Saliva Collection
Saliva samples are collected at baseline and after the final treatment session to assess epigenetic changes
Treatment Details
Interventions
- MDMA-Assisted Psychotherapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Southern California
Lead Sponsor
Lykos Therapeutics
Collaborator
Multidisciplinary Association for Psychedelic Studies
Collaborator