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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MDMA-assisted therapy | Participants undergoing MDMA-assisted therapy in the main study, MP-8 (NCT#01211405) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in brain activity measured via fMRI while listening to trauma scripts | Brain activity measured via functional magnetic resonance imaging (fMRI) after listening to trauma-related scripts. | Baseline, two months after final experimental session |
| Measure | Description | Time Frame |
|---|---|---|
| Change in heart rate variability in response to trauma script | Assessment of Heart rate variability (HRV) in response to trauma-related scripts; a potential physiological correlate of response to treatment for PTSD | Baseline, one month post-drug |
| Change in Self Compassion Scale Score |
| Measure | Description | Time Frame |
|---|---|---|
| Psychotherapy Process Q-set (PSQ) | System of coding psychotherapeutic processes in observed psychotherapy (pre-drug) | 3 - 7 weeks post enrollment |
| Psychotherapy Process Q-set (PSQ) | System of coding psychotherapeutic processes in observed psychotherapy (drug-assisted psychotherapy session) |
Inclusion Criteria:
Exclusion Criteria:
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Participants enrolled in the parent study, MP-8
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| Name | Affiliation | Role |
|---|---|---|
| Michael C Mithoefer, MD | Private Practice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Offices of Michael Mithoefer | Mt. Pleasant | South Carolina | 29464-4345 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36713926 | Derived | Singleton SP, Wang JB, Mithoefer M, Hanlon C, George MS, Mithoefer A, Mithoefer O, Coker AR, Yazar-Klosinski B, Emerson A, Doblin R, Kuceyeski A. Altered brain activity and functional connectivity after MDMA-assisted therapy for post-traumatic stress disorder. Front Psychiatry. 2023 Jan 12;13:947622. doi: 10.3389/fpsyt.2022.947622. eCollection 2022. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Dec 3, 2013 | Jun 14, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D018817 | N-Methyl-3,4-methylenedioxyamphetamine |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 |
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|
| Therapy | Behavioral | Manualized therapy |
|
Self-report measure of self-compassion |
| Baseline, one month post-drug |
| Change in heart rate variability in response to trauma script | Assessment of Heart rate variability (HRV) in response to trauma-related scripts; a potential physiological correlate of response to treatment for PTSD | Baseline, two months post final drug administration |
| Change in Self Compassion Scale Score | Self-report measure of self-compassion | Baseline, two months post final drug administration |
| Change in brain activity measured via fMRI while listening to trauma scripts | Brain activity measured via functional magnetic resonance imaging (fMRI) after listening to trauma-related scripts | Baseline, one month post-drug |
| 8 - 16 weeks post-enrollment |
| Psychotherapy Process Q-set (PSQ) | System of coding psychotherapeutic processes in observed psychotherapy (end of treatment after final experimental session) | 17-27 weeks post-enrollment |
| Organic Chemicals |