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Study of the Effects of MDMA/Ecstasy on Water Regulation, Sleep, and Cognition.

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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.

Details

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).

Topics:Healthy Volunteers

Registry

Registry linkNCT01053403