Safety and efficacy of MDMA-assisted therapy for... — Clinical Trial Details

This clinical trial will investigate the safety and efficacy of a 14-week MDMA assisted psychotherapy treatment for PTSD. The primary outcome measure will assess clinician-rated changes in PTSD severity, alongside a range of secondary and exploratory measures assessing functional impairment associated with PTSD, quality of life, relationships to adverse childhood experiences, and changes in comorbid psychiatric symptoms. Safety outcome measures will also investigate the safety and tolerability of the drug.

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).

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.

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Safety and efficacy of MDMA-assisted therapy for Post-Traumatic Stress Disorder in Military Veterans and First Responders: a randomised waitlist-controlled clinical trial [MMP-1]

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