Randomized double-blind, placebo-controlled crossover Phase I study (n=16) testing clonidine (150 µg) pre-treatment versus placebo on pharmacodynamics and pharmacokinetics of MDMA (125 mg) in healthy volunteers.
Randomized double-blind, placebo-controlled crossover with four experimental sessions. Clonidine (150 µg) or placebo is given 1 hour before MDMA (125 mg) or placebo to 16 healthy volunteers; subjective and cardiovascular responses and plasma pharmacokinetics are repeatedly assessed.
The study tests whether attenuation of norepinephrine release by clonidine reduces the subjective and physiological effects of MDMA, clarifying the role of noradrenergic signalling in MDMA responses.
Within-subject crossover; four sessions testing clonidine or placebo with MDMA or placebo.
MDMA 125 mg single dose administered ~1 h after clonidine/placebo.
Clonidine 150 µg given 1 h before MDMA or placebo.
Placebo capsules identical to MDMA or clonidine.