Placebo-controlled, double-blind, within-subject study (n=12) assessing acute and 24–48 h post-dose effects of a single 1.5 mg/kg oral MDMA dose on sleep, water homeostasis, and cognition in experienced users.
Randomized, quadruple-blind crossover in experienced MDMA users with two inpatient stays to compare single-dose MDMA (1.5 mg/kg) versus matched placebo and to characterise acute and discontinuation effects up to 48 hours.
Primary outcomes include polysomnography and actigraphy measures of sleep architecture, and markers of water and sodium homeostasis including arginine vasopressin and urine free water excretion; effects of water loading are assessed.
Secondary outcomes examine acute changes in mood, sociability, risk-taking and cognitive tasks, oxidative stress markers, and genetic moderators (serotonin transporter promoter short form).
Within-subject, placebo-controlled crossover comparing single-dose MDMA (1.5 mg/kg) and matched placebo across two inpatient stays.
Single dose 1.5 mg/kg MDMA; administered during inpatient visits; crossover design; each subject receives MDMA at least once.
Matched placebo.