MDMA-assisted therapy for Post-Traumatic Stress Disorder in Military Veterans and First Responders
- Conditions
- Post-Traumatic Stress DisorderMental Health - Other mental health disorders
- Registration Number
- ACTRN12623000971639
- Lead Sponsor
- Monash University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
*Adults with current diagnosis of PTSD.
*Military veteran or first responder
*Proficiency in English.
*Availability of appropriate Support Person (relative, spouse, close friend) who can transport and provide basic support to participants following the dosing sessions.
*Ability to discontinue certain excluded medications if deemed safe, appropriate, agreeable; if discontinuation can occur under guidance of prescribing doctor. (Note, prospective participants are not required to discontinue any medications prior to written confirmation of their enrolment into the study).
*Agree to all study-related requirements.
• Any CNS disorders
• Current or past history of meeting DSM-5 criteria for certain excluded psychiatric indications.
• Have history of any medical condition that could make receiving a sympathomimetic drug harmful, or have any relevant cardiovascular conditions
• Diagnosis of epilepsy or previous seizures
• Major liver, kidney, thyroid abnormalities
• Insulin-dependent diabetes (unless well-managed)
• Pregnant, nursing, trying to conceive
• Taking, and inappropriate to discontinue, excluded medications, including SSRIs, SNRIs, potent metabolic inducers or inhibitors.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean group difference in symptoms of PTSD as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score[ Baseline (Week 1), Week 18]
- Secondary Outcome Measures
Name Time Method