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
Visit trial
Status Active, not recruiting
Results Published No
Start date 20 November 2018
End date 31 December 2024
Phase Phase III
Design Blinded
Type Interventional
Generation First
Participants 44
Sex All
Age 18- 99
Therapy Yes

Trial Details

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.

NCT Number NCT06189027

Sponsors & Collaborators

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

Data attribution

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