Clinical Trial: Pharmacological Interaction Between Carvedilol and Methylenedioxymethamphetamine (MDMA)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effects of Carvedilol on the Cardiovascular and Subjective Response to MDMA (3,4-Methylenedioxymethamphetamine, "Ecstasy")

Brief Summary: The purpose of this study is to determinate the effect of a pre-treatment with carvedilol, a alpha- and beta-adrenergic receptor blocker, on the pharmacodynamics and pharmacokinetics of 3,4-methylenedioxymethamphetamine (MDMA, "Ecstasy"). The investigators hypothesize that carvedilol will attenuate the cardiovascular and subjective response to MDMA.

Detailed Summary: 3,4-methylenedioxymethamphetamine (MDMA, "ecstasy") is widely used by young people for its euphoric effects. MDMA releases serotonin (5-HT), dopamine, and norepinephrine (NE). NE release is thought to mediate the cardiovascular effects of MDMA and may also contribute to its psychostimulant effects. However, the functional role of adrenergic postsynaptic receptors in the cardiovascular and subjective effects of MDMA in humans is largely unclear. To determine the role of alpha- and beta adrenergic receptors in the response to MDMA in humans the investigators test the effects of the alpha- and beta-receptor blocker carvedilol on the physiological and subjective effects of MDMA. The investigators use a randomized double-blind placebo-controlled cross-over design with four experimental sessions. Carvedilol or placebo will be administered 1 h before MDMA or placebo to 16 healthy volunteers. Subjective and cardiovascular responses will be repeatedly assessed throughout the experiments and plasma samples are collected for pharmacokinetics. The primary hypothesis is that carvedilol will significantly reduce the blood pressure response to MDMA.
Sponsor: University Hospital, Basel, Switzerland

Current Primary Outcome: Effect of carvedilol on the blood pressure response to MDMA [ Time Frame: 24 h ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Effect of carvedilol on the subjective response to MDMA [ Time Frame: 24 h ]
  • Effect of carvedilol on neuroendocrine effects of MDMA [ Time Frame: 7 h ]
  • Effect of carvedilol on pharmacokinetics of MDMA [ Time Frame: 7 h ]


Original Secondary Outcome: Same as current

Information By: University Hospital, Basel, Switzerland

Dates:
Date Received: January 4, 2011
Date Started: January 2011
Date Completion:
Last Updated: January 20, 2016
Last Verified: January 2016