Clinical Trial: Interaction Between Duloxetine and 3,4-Methylenedioxymethamphetamine (MDMA, Ecstasy)

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

Official Title: Pharmacological Interaction Between Duloxetine and 3,4-Methylenedioxymethamphetamine (MDMA, Ecstasy): Pharmacodynamics (PD) and Pharmacokinetics (PK)

Brief Summary: The purpose of this study is to determinate the effect of a pre-treatment with the combined serotonin (5-HT) and norepinephrine (NE) transport blocker duloxetine on the pharmacodynamics and pharmacokinetics of 3,4-methylenedioxymethamphetamine (MDMA, "Ecstasy"). The investigators hypothesize that duloxetine 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 through an interaction with the corresponding presynaptic monoamine uptake transporter. 5-HT transport inhibitors block MDMA-induced 5-HT release in vitro or in animals and also attenuate the subjective and cardiovascular response to MDMA in humans. NE transport inhibitors similarly prevent the MDMA-induced release of NE in cell assays and attenuate behavioral effects of MDMA in animals. Effects of the NE transporter inhibitor reboxetine on the response to MDMA in humans are currently investigated. Here we suggest evaluating effects of pretreatment with the combined 5-HT and NE transport blocker duloxetine on the pharmacodynamics and pharmacokinetics of MDMA. The study will use a randomized double-blind cross-over design with four experimental sessions. Duloxetine (120 mg) or placebo will be administered 16 h and 4 h before the administration of MDMA (125 mg) or placebo to 16 healthy volunteers. Subjective and cardiovascular responses and plasma samples for pharmacokinetics will be repeatedly assessed throughout the experiments.
Sponsor: University Hospital, Basel, Switzerland

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Effect of duloxetine on cardiovascular effects of MDMA [ Time Frame: 6h ]
  • Effect of duloxetine on pharmacokinetics of MDMA [ Time Frame: 6h ]
  • Effect of MDMA on duloxetine pharmacokinetics [ Time Frame: 6h ]
  • Tolerability of MDMA and duloxetine [ Time Frame: 7 days ]
  • Effect of duloxetine on neuroendocrine responses to MDMA [ Time Frame: 6h ]


Original Secondary Outcome: Same as current

Information By: University Hospital, Basel, Switzerland

Dates:
Date Received: October 5, 2009
Date Started: November 2009
Date Completion:
Last Updated: January 24, 2013
Last Verified: January 2013