Posttraumatic Stress Disorder
Conditions
Keywords
PTSD, MDMA, Brain activity, fMRI, Heart rate variability, Physiological correlate
Brief 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.
Interventions
DRUGMidomafetamine
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
BEHAVIORALTherapy
Manualized therapy
Sponsors
Lykos Therapeutics
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in brain activity measured via fMRI while listening to trauma scripts | Baseline, two months after final experimental session | Brain activity measured via functional magnetic resonance imaging (fMRI) after listening to trauma-related scripts. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in heart rate variability in response to trauma script | 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 | Baseline, one month post-drug | Self-report measure of self-compassion |
| Change in brain activity measured via fMRI while listening to trauma scripts | Baseline, one month post-drug | Brain activity measured via functional magnetic resonance imaging (fMRI) after listening to trauma-related scripts |
Other
| Measure | Time frame | Description |
|---|---|---|
| Psychotherapy Process Q-set (PSQ) | 3 - 7 weeks post enrollment | System of coding psychotherapeutic processes in observed psychotherapy (pre-drug) |
Countries
United States
Outcome results
None listed