Phase I triple-blind, random-order, 3-period crossover in healthy volunteers (n=25) comparing MDMA 120 mg + 60 mg booster (2 h), MDMA 120 mg + placebo, and placebo + placebo to assess duration of acute subjective, physiological and endocrine effects.
This basic science study examines acute effects of MDMA in healthy volunteers to compare duration and intensity of subjective, physiological and endocrine responses when a booster dose is given versus no booster and versus placebo.
Subjects undergo three sessions in random order: MDMA 120 mg with a 60 mg booster at 2 hours, MDMA 120 mg with placebo at 2 hours, and placebo with placebo. The design tests whether a booster prolongs acute effects or increases side effects.
Outcomes include acute subjective measures, cardiovascular and thermoregulatory parameters, and endocrine markers; safety and tolerability are monitored throughout each session.
Initial 120 mg MDMA followed by 60 mg booster at 2 hours.
Second dose 60 mg at 2 hours after initial 120 mg.
120 mg MDMA followed by placebo at 2 hours.
Placebo given at 2 hours.
Placebo at 0 h and placebo at 2 h.
Oral placebo at both time points.