This Phase I, open-label trial (n=30) will study the psychological and biological effects of MDMA-assisted therapy in mental health providers who are training to become MDMA-assisted therapists. Participants will receive an initial oral dose of 120 mg of MDMA in a therapeutic setting, followed 1.5–2 hours later by a supplemental 40 mg dose, unless not tolerated or declined.
The study, led by Rachel Yehuda at the Icahn School of Medicine at Mount Sinai, aims to evaluate whether a brief intervention — consisting of one preparatory therapy session, a single MDMA-assisted therapy session, and an integration session the next day — can improve overall mental well-being in healthy mental healthcare providers. Secondary measures include the effects on burnout, self-efficacy (how confident a person feels in their professional abilities), mood, psychological flexibility, self-compassion, quality of life, and avoidance behaviours.
This research also serves as part of professional training for MDMA-assisted therapists, giving providers first-hand experience of the therapy to enhance their understanding of its therapeutic potential. Assessments will take place before, during, and up to one month after treatment, with safety and participant well-being closely monitored.
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Icahn School of Medicine at Mount SinaiThis company doesn't have a full profile yet, it is linked to a clinical trial.