NCT06189027

Epigenetics and MDMA-Assisted Psychotherapy for PTSD

Epigenetic Regulation of Stress-related Genes in Relation to MDMA-Assisted Psychotherapy Treatment for Post-Traumatic Stress Disorder

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

For a detailed description of the parent study see "A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD" (ClinicalTrials.gov Identifier: NCT03537014). The current substudy the site coordinators at participating sites in the multi-site phase 3 clinical trial will collect saliva from research participants in the parent study at the following time points: 1. Collect saliva prior to first MDMA (vs placebo) treatment session at the Baseline Visit 3 or Visit 4 for the Phase 3 parent study, prior to the first MDMA (vs placebo) treatment session. 2. Collect saliva following final MDMA (vs placebo) treatment session at Primary Outcome Visit 19 or Visit 20 in the Phase 3 parent study, approximately 18 weeks after the first MDMA (vs placebo) treatment session. The collection of saliva will be accomplished using the Oragene DNA OG-500 salivary DNA kits (https://www.dnagenotek.com/ROW/products/collection-human/oragene-dna/500-series/OG-500.html). The salivary samples take no more than 2-3 minutes to collect by passive drool into the salivary collection kit.

Conditions

• PTSD

Interventions

Type	Name	Description
DRUG	MDMA	Adjunctive administration of MDMA to assist psychotherapeutic process
BEHAVIORAL	Psychotherapy	Psychotherapy aimed at assisting with PTSD symptom reduction

Timeline

• Start date: 2018-11-20
• Primary completion: 2023-11-01
• Completion: 2024-12-31
• First posted: 2024-01-03
• Last updated: 2024-01-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study