About this trial
This is a phase 1, open-label study to assess changes in mental well-being following MDMA administration within a therapeutic setting, in mental health providers who are in training to become MDMA assisted therapists. Secondary outcome measures will examine the effects on provider burnout, provider self-efficacy, mood, self-compassion, quality of life, and other psychological factors. Participants will work with a co-therapy pair as they engage in a preparatory session, one experimental session with MDMA, and an integration session the following day.
Eligibility criteria
Qualifiers
Are at least 18 years at the time of signing the informed consent.
Fluent in English
Able to swallow pills
Agree to have study visits audiovisually recorded
Disqualifiers
Have engaged in a new form of psychiatric or mental health care within 12 weeks of enrollment
Have a current alcohol or cannabis use disorder of any severity within the 12 months prior to enrollment
Have a substance use disorder of any severity within 12 months prior to enrollment
Any suicidal ideation within the last 6 months
Trial design
Treatments tested in this trial
- MDMA Hydrochloride
Treatment groups
Sponsors and collaborators
Rachel Yehuda
Lead sponsor
Icahn School of Medicine at Mount Sinai
Sponsor institution