Pharmacological Interaction Between Carvedilol and Methylenedioxymethamphetamine (MDMA)
Randomised, double-blind, placebo-controlled crossover in 16 healthy volunteers testing carvedilol (50 mg) pre-treatment on the pharmacodynamics and pharmacokinetics of oral MDMA (125 mg).
Details
This randomized, quadruple-blind, placebo-controlled crossover study in healthy adults evaluates whether carvedilol (50 mg) attenuates the cardiovascular and subjective effects of a single oral MDMA dose (125 mg).
Each participant completes four experimental sessions in which carvedilol or placebo is given 1 hour before MDMA or placebo; subjective and cardiovascular responses are measured repeatedly and plasma is collected for pharmacokinetics and pharmacodynamics.
Primary hypothesis: carvedilol will significantly reduce the blood pressure response to MDMA; secondary outcomes include heart rate, subjective effects, and PK measures.