Epigenetics and MDMA-Assisted Psychotherapy for PTSD

This add-on substudy (n=44) to the Phase III clinical trial “A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD” (NCT03537014) conducted by the University of Southern California aims to investigate the epigenetic regulation of stress-related genes in relation to MDMA-assisted psychotherapy treatment for Post-Traumatic Stress Disorder (PTSD).

The parent study, led by the MAPS Public Benefit Corporation, is a randomized controlled trial comparing the efficacy of MDMA-assisted psychotherapy to placebo-assisted psychotherapy in participants with PTSD. The substudy involves collecting saliva samples from research participants at baseline and after treatment sessions to assess changes in the methylation of stress-associated genes, such as glucocorticoid receptor NR3C1, FKBP5, and Brain Derived Neurotrophic Factor (BDNF), and their correlation with improvements in PTSD symptoms.

Participants in the substudy must meet the eligibility criteria outlined in the parent phase III trial. The study utilises the Oragene DNA OG-500 salivary DNA kits for sample collection.

It started on November 20, 2018, with an estimated completion date of December 31, 2024, and has enrolled 45 participants. The substudy is interventional, phase III, and involves a randomised crossover allocation with triple masking.

The primary outcome measures include quantifying changes in gene methylation and correlating them with PTSD symptom changes over a four-month period. The principal investigator for this substudy is Rael Cahn, MD, PhD, from the University of Southern California.

Topic PTSD
Compound MDMA
Country United States of America
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Trial Details



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Sponsors & Collaborators

MAPS PBC
MAPS Public Benefit Corporation (MAPS PBC) is the 'benefit above profit' corporation that is fully owned by MAPS.

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