NCT02102802

Exploring Mechanisms of Action in MDMA-assisted Psychotherapy for PTSD

Exploring Mechanisms of Action of ±3,4-methylenedioxymethamphetamine (MDMA)- Assisted Psychotherapy for Posttraumatic Stress Disorder (PTSD)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: Lykos Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational sub-study is to provide information on how MDMA-assisted therapy affects the brain and body of people with chronic PTSD. The main question it aims to answer is: Is PTSD symptom reduction associated with changes in heart rate variability and brain activity? Participants from the MP-8 study will be invited to enroll in this sub-study where they will undergo an fMRI brain scan and other measurements of body function.

Detailed description

This exploratory sub-study will identify psychotherapeutic processes occurring during MDMA- assisted psychotherapy in people with chronic PTSD and assess the feasibility of exploring physiological correlates of clinical outcomes in subjects enrolled in the ongoing clinical trial of MDMA-assisted psychotherapy, NCT #: NCT01211405. The sub-study will be conducted in collaboration with researchers at the Medical University of South Carolina (MUSC), Smith College and the New School for Social Research. To support the clinical outcomes measured by CAPS from the MP-8 study, the sponsor is interested in correlations of outcomes with treatment-related changes in potential biological markers of PTSD, measured by heart rate variability (HRV) and fMRI. Brain activity while listening to neutral and personalized trauma-related scripts will take place at baseline and after experimental MDMA-assisted psychotherapy with low, medium, or full dose MDMA. The fMRI scan will be followed by a Diffusion Tensor Imaging (DTI) scan. After each scanning session, pulse measurements will be extracted as a digital data file from which HRV will be calculated. FMRI scans and HRV measurements will occur at baseline for participants in all conditions, one month after the second experimental session and again after a final experimental session for participants in the low or medium dose condition, and two months after the final experimental session for participants in the full dose condition. Participants will complete the Self-Compassion Scale, a self-report measure of self-compassion at Baseline and after the final MDMA-assisted psychotherapy session. Psychotherapeutic processes will be assessed via observing psychotherapy and sorting a set of 100 therapy-related items as a means of describing the interactions. Trained coders will observe at least one pre-drug psychotherapy session, one experimental (drug-assisted psychotherapy) session and one post-drug psychotherapy session.

Conditions

• Posttraumatic Stress Disorder

Interventions

Type	Name	Description
DRUG	Midomafetamine	125, 75, or 30 mg midomafetamine HCl followed 1.5 to 2 hours later by a supplemental dose of midomafetamine HCl half the initial dose
BEHAVIORAL	Therapy	Manualized therapy

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-08-03
• Completion: 2015-08-03
• First posted: 2014-04-03
• Last updated: 2024-11-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study