Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers
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.
Details
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.