Acute Effects of 3,4-methylenedioxymethamphetamine (MDMA) With and Without a Booster Dose
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.
Details
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.