None listed
Conditions
Brief summary
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.
Interventions
MDMA-assisted therapy: This study is a randomised controlled trial to test a 14-week program of MDMA-assisted therapy compared to a waitlist controlled condition. Treatment comprises 12 psychotherapy sessions and two dosing sessions using 3,4-methylenedioxymethamphetamine (MDMA). Participants will be supported throughout by two qualified mental health professionals (therapist dyad) for the duration of treatment.
The two dosing sessions will be spaced four weeks apart, using an initial dose of
MDMA-assisted therapy: This study is a randomised controlled trial to test a 14-week program of MDMA-assisted therapy compared to a waitlist controlled condition. Treatment comprises 12 psychotherapy sessions and two dosing sessions using 3,4-methylenedioxymethamphetamine (MDMA). Participants will be supported throughout by two qualified mental health professionals (therapist dyad) for the duration of treatment. The two dosing sessions will be spaced four weeks apart, using an initial dose of 120mg followed by a supplementary 40mg dose 1.5 hours later, unless contraindicated. Each session will last approx. 8 hours with two trial therapists providing support throughout. Participants will also attend 12 psychotherapy sessions. These include three weekly preparatory sessions before the first dose, three integration sessions following the first dose, and six integration sessions following the second dose. Preparatory psychotherapy will include a range of approaches supporting safe and effective dosing sessions, and integrative psychotherapy will include a range of approaches supporting sustained outcomes. All psychotherapy sessions will run for 90 minutes and provide support relevant to PTSD symptoms and psychedelic experience. Adherence to all sessions and any deviation from protocol will be documented.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
*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.
Exclusion criteria
• 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.
Outcome results
None listed