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]

Monash University0 sites24 target enrollmentSeptember 6, 2023

Overview

No summary available.

Registry

who.int

Start Date

September 6, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•\*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.