This study will compare the effects of methylenedioxymethamphetamine (MDMA) and placebo on mood and psychological experience in people trained to practice MDMA-assisted psychotherapy in a therapy-like setting.
Randomized, double-blind, triple-masked, crossover Phase 1 study in healthy volunteers trained in MDMA-assisted psychotherapy (actual n=107). Each participant receives one MDMA session (120 mg oral, supplemental 40 mg optional 1.5–2.5 h later) and one lactose placebo session in random order with at least two days between sessions.
Each experimental session is preceded by a non-drug preparatory session and followed by an integrative session. Outcomes include mood, interpersonal closeness, psychological symptoms, blood pressure, heart rate, body temperature, and personality measures with telephone follow-up at 1 and 2 months.
Active MDMA session in crossover (may include supplemental dose).
120 mg initial oral MDMA; supplemental 40 mg may be given 1.5–2.5 hours later; sessions in crossover design.
Lactose inactive placebo matching capsules in crossover.
Lactose inactive placebo matching MDMA capsules; equivalent initial and supplemental doses.