Exploring Mechanisms of Action in MDMA-assisted Psychotherapy for PTSD
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|ClinicalTrials.gov Identifier: NCT02102802|
Recruitment Status : Completed
First Posted : April 3, 2014
Last Update Posted : September 24, 2021
|Condition or disease||Intervention/treatment|
|Posttraumatic Stress Disorder||Drug: Full dose MDMA|
PTSD is a complex psychiatric disease characterized by a deficit in fear extinction, hyperarousal, emotional numbing, and intrusive symptoms that cause the patient to persistently re-experience a traumatic event over a period longer than a month. PTSD is considered chronic when symptoms are present for at least six months. MDMA-assisted psychotherapy is an innovative experimental mode of treatment that combines psychotherapeutic techniques with the administration of MDMA. It may amplify certain aspects of psychotherapy, as the pharmacological action of MDMA is thought to act as an adjunct to psychotherapy. With positive results in two studies and ongoing Phase 2 clinical studies it is important to further characterize the psychotherapeutic processes that occur during treatment sessions conducted according to the manualized method of MDMA-assisted psychotherapy. Changes in physiological status or brain activity that are associated with improvement or recovery in people with chronic PTSD may offer a means of assessing treatment response that relies less on self-report. This may be particularly important in studies with MDMA-assisted psychotherapy where blinding is difficult due to the psychoactive nature of the investigational product. This study is also interested in identifying and categorizing psychotherapeutic processes taking place during MDMA-assisted psychotherapy. The sub-study will also examine elements of the experience with a self-report measure of self-compassion.
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 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 or 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.
|Study Type :||Observational|
|Actual Enrollment :||10 participants|
|Official Title:||Exploring Mechanisms of Action of ±3,4-methylenedioxymethamphetamine (MDMA)- Assisted Psychotherapy for Posttraumatic Stress Disorder (PTSD)|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||August 3, 2015|
|Actual Study Completion Date :||August 3, 2015|
Full dose MDMA
Participants will receive 125 mg MDMA possibly followed 1.5 to 2 h later by 62.5 mg MDMA
Drug: Full dose MDMA
Participants receiving 125 mg MDMA
- 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.
- 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
- Change in Self Compassion Scale Score [ Time Frame: Baseline, one month post-drug ]Self-report measure of self-compassion
- 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
- Change in Self Compassion Scale Score [ Time Frame: Baseline, two months post final drug administration ]Self-report measure of self-compassion
- 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
- Psychotherapy Process Q-set (PSQ) [ Time Frame: 3 - 7 weeks post enrollment ]System of coding psychotherapeutic processes in observed psychotherapy (pre-drug)
- Psychotherapy Process Q-set (PSQ) [ Time Frame: 8 - 16 weeks post-enrollment ]System of coding psychotherapeutic processes in observed psychotherapy (drug-assisted psychotherapy session)
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102802
|United States, South Carolina|
|Offices of Michael Mithoefer|
|Mount Pleasant, South Carolina, United States, 29464-4345|
|Principal Investigator:||Michael C Mithoefer, MD||Private Practice|