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Completed

NCT Number: NCT02102802

Exploring Mechanisms of Action in MDMA-assisted Psychotherapy for PTSD

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.

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Key information

Conditions

Posttraumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Offices of Michael Mithoefer

Mt. Pleasant, South Carolina, 29464-4345, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Enrolled in the parent study, "A Randomized, Triple-Blind, Phase 2 Pilot Study Comparing 3 Different Doses of MDMA in Conjunction with Manualized Psychotherapy in 24 Veterans, Firefighters, and Police Officers with Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)." NCT #: NCT01211405

Exclusion criteria

  • Mass brain lesion
  • Have metal in their skulls,
  • Having brain or heart pacemakers
  • History of major head trauma
  • Have past or present panic or extreme discomfort with being in small enclosed spaces (claustrophobia)

Treatment and study plan

Midomafetamine

Drug

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

Other names: 3,4-methylenedioxymethamphetamine, MDMA

Therapy

Behavioral

Manualized therapy

Primary outcomes

  1. Change in brain activity measured via fMRI while listening to trauma scripts

    Time frame: Baseline, two months after final experimental session

    Brain activity measured via functional magnetic resonance imaging (fMRI) after listening to trauma-related scripts.

Secondary outcomes

  1. Change in heart rate variability in response to trauma script

    Time frame: Baseline, one month post-drug

    Assessment of Heart rate variability (HRV) in response to trauma-related scripts; a potential physiological correlate of response to treatment for PTSD

  2. Change in Self Compassion Scale Score

    Time frame: Baseline, one month post-drug

    Self-report measure of self-compassion

  3. Change in heart rate variability in response to trauma script

    Time frame: Baseline, two months post final drug administration

    Assessment of Heart rate variability (HRV) in response to trauma-related scripts; a potential physiological correlate of response to treatment for PTSD

  4. Change in Self Compassion Scale Score

    Time frame: Baseline, two months post final drug administration

    Self-report measure of self-compassion

  5. Change in brain activity measured via fMRI while listening to trauma scripts

    Time frame: Baseline, one month post-drug

    Brain activity measured via functional magnetic resonance imaging (fMRI) after listening to trauma-related scripts

Other outcomes

  1. Psychotherapy Process Q-set (PSQ)

    Time frame: 3 - 7 weeks post enrollment

    System of coding psychotherapeutic processes in observed psychotherapy (pre-drug)

  2. Psychotherapy Process Q-set (PSQ)

    Time frame: 8 - 16 weeks post-enrollment

    System of coding psychotherapeutic processes in observed psychotherapy (drug-assisted psychotherapy session)

  3. Psychotherapy Process Q-set (PSQ)

    Time frame: 17-27 weeks post-enrollment

    System of coding psychotherapeutic processes in observed psychotherapy (end of treatment after final experimental session)

Sponsors and collaborators

Lead sponsor

Resilient Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 3, 2014
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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