This study is testing a new, emerging treatment for young adults (ages 18-26) with Posttraumatic Stress Disorder (PTSD). The treatment is combining the substance, MDMA, with up to three psychotherapy sessions, also known as MDMA-Assisted Therapy (MDMA-AT). The main questions it aims to answer are: * Is the treatment safe and feasible to administer? * Does the treatment improve PTSD symptoms? Participants will be asked to: * Complete screening procedures, including a medical and psychiatric evaluation to ensure safe participation * Attend up to three preparatory talk therapy sessions prior to the first MDMA-AT dosing session * Attend three integration talk therapy sessions after each MDMA-AT dosing session * Attend up to three total MDMA-AT dosing sessions * Complete assessments from baseline to 38-weeks post-baseline * Complete a fMRI scan at baseline and at 18-weeks post-treatment * Complete self-report measures and ecological momentary assessments (EMAs) across the study period
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Recruiting young adults with PTSD for an interventional study testing a combination of MDMA and talk therapy.
McLean Hospital
Belmont, Massachusetts, United States
Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest
The safety of MDMA-AT will be assessed by the number, type, and severity of adverse events.
Time frame: Assessed from baseline to 18-weeks post baseline, and again at two follow-up timepoints (26- and 38-weeks post-baseline).
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
The efficacy of MDMA-AT will be assessed using the CAPS-5 total severity score. The CAPS-5 is a 30-item structured clinical interview used to diagnose PTSD, including overall PTSD severity. The severity score ranges from 0 to 80, with higher scores indicating greater overall severity of PTSD symptoms
Time frame: From baseline to 18-weeks post-baseline.
The PTSD Checklist for DSM-5 (PCL-5)
The PCL-5 is a 20-item self-report measure of PTSD symptom severity. Responses range from 0 (not at all) to 4 (extremely), and total scores range from 0-80, with higher scores indicating greater PTSD symptom severity.
Time frame: From baseline to post-treatment (i.e., 18 weeks post-baseline), and again at two follow up timepoints (26- and 38-weeks post-baseline).
The Inventory of Altered Self Capacities (IASC)
The IASC is a 63-item self-report measure of problems in identity, affect regulation, and interpersonal functioning. The scale produces a total score and seven subscores (representing Interpersonal Conflicts; Idealizing-Devaluing; Abandonment Concerns; Identity Impairment; Susceptibility to Influence; Emotion Dysregulation; and Tension Reduction Activities) representing common areas of impairment in individuals with PTSD as a result of childhood trauma.
Time frame: From baseline to post-treatment (i.e., 18 weeks post-baseline), and again at two follow up timepoints (26- and 38-weeks post-baseline).
Cognitive Flexibility Inventory (CFI)
The CFI is a 20-item self-report measure of adaptive cognitive responses to stressful life events. Responses range from 1 (strongly disagree) to 7 (strongly agree), and total scores range from 20 and 140, where higher scores indicate more cognitive flexibility.
Time frame: From baseline to post-treatment (i.e., 18 weeks post-baseline), and again at two follow up timepoints (26- and 38-weeks post-baseline).
Self Compassion Scale Short Form (SCS-SF)
The SCS-SF is a 12-item self-report measure of self-kindness. It is made up of six Self Care items and the six Self Disparagement. Responses range from 1 (almost never) to 5 (almost always), with higher scores indicating high Self Care together with low Self Disparagement.
Time frame: From baseline to post-treatment (i.e., 18 weeks post-baseline), and again at two follow up timepoints (26- and 38-weeks post-baseline).
Sheehan Disability Scale (SDS)
The SDS is 3-item a self-report measure that assesses measures impairment in three domains: work/school, social life/leisure activities, and family life/home responsibilities. A total score ranges from 0 (no impairment) to 30 (severe impairment).
Time frame: From baseline to post-treatment (i.e., 18 weeks post-baseline), and again at two follow up timepoints (26- and 38-weeks post-baseline).
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