This Phase I, open-label trial (n=30) will study the psychological and biological effects of MDMA-assisted therapy in mental health providers in training, with a single experimental MDMA session (120 mg initial oral dose with optional 40 mg supplemental dose 1.5–2 hours later), plus preparatory and integration sessions.
Phase I open-label study to evaluate psychological, biological and safety outcomes following one MDMA-assisted therapy session in mental healthcare providers or trainees learning to conduct MDMA-AT.
Participants receive one preparatory session, a single experimental MDMA session (120 mg oral MDMA HCl with an optional 40 mg supplemental dose 1.5–2 hours later), and an integration session the following day; outcomes include mental wellbeing, provider burnout, self-efficacy, mood, psychological flexibility, and quality of life assessed up to one month.
One-session MDMA-assisted therapy with preparatory and next-day integration session.
Initial 120 mg oral MDMA HCl followed 1.5–2 hours later by supplemental 40 mg if tolerated; supplemental dose may be withheld or declined.