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

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

Official Title: Pharmacological Interaction Between Clonidine and 3,4-methylenedioxymethamphetamine (MDMA, Ecstasy)

Brief Summary: The purpose of this study is to determinate the effect of a pre-treatment with centrally acting alpha2-receptor agonist clonidine on the pharmacodynamics and pharmacokinetics of 3,4-methylenedioxymethamphetamine (MDMA, "Ecstasy"). The investigators hypothesize that clonidine will attenuate the subjective and cardiovascular 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), norepinephrine (NE), and dopamine. It is unknown which of these monoamines mainly contributes to the subjective and physiological effects of MDMA in humans. Clonidine is a centrally acting alpha2-receptor agonist and sympatholytic which attenuates the release of NE from presynaptic nerve terminals and also lowers NE plasma concentration. To determine the role of NE in the response to MDMA in humans we test the effects of a clonidine pretreatment on the pharmacodynamics and pharmacokinetics of MDMA. We use a randomized double-blind placebo-controlled cross-over design with four experimental sessions. Clonidine (150 μg) or placebo will be administered 1 h before the administration of MDMA (125 mg) or placebo to 16 healthy volunteers. Subjective and cardiovascular responses will be repeatedly assessed throughout the experiments and plasma samples are collected for pharmacokinetics. We hypothesize that clonidine will significantly attenuate predominantly the cardiovascular response to MDMA.
Sponsor: University Hospital, Basel, Switzerland

Current Primary Outcome: Effect of clonidine on the subjective response to MDMA [ Time Frame: 24 h ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Effect of clonidine on cardiovascular effects of MDMA [ Time Frame: 8 h ]
  • Effect of clonidine on pharmacokinetics of MDMA [ Time Frame: 8 h ]
  • Effect of MDMA on clonidine pharmacokinetics [ Time Frame: 8 h ]
  • Tolerability of MDMA and clonidine [ Time Frame: 8 h ]
  • Effect of clonidine on neuroendocrine responses to MDMA [ Time Frame: 8 h ]


Original Secondary Outcome: Same as current

Information By: University Hospital, Basel, Switzerland

Dates:
Date Received: May 31, 2010
Date Started: July 2010
Date Completion:
Last Updated: January 24, 2013
Last Verified: January 2013