Pharmacological Interaction Between Clonidine and Methylenedioxymethamphetamine (MDMA)

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.

Intervention / Treatment

  • Drug: 3,4-methylenedioxymethamphetamine
  • Drug: Clonidine
  • Drug: Placebo

Condition or Disease

  • Mood Disorder
  • Substance-Related Disorders
  • Amphetamine-Related Disorders


Study Design

Study type: Interventional
Status: Completed
Study results: No Results Available
Age: 18 Years to 45 Years   (Adult)
Enrollment: 16 ()
Funded by: Other


Clinical Trial Dates

Start date: Jul 01, 2010
Primary Completion: Dec 01, 2010
Completion Date: Dec 01, 2010
Study First Posted: Jun 03, 2010
Results First Posted: Aug 30, 2020
Last Updated: Jan 25, 2013

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

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.

Eligibility Criteria

Sex: All
Minimum Age: 18
Maximum Age: 45

More Details

NCT Number: NCT01136278
Other IDs: EK 353/09
Study URL:
Last updated: Jun 17, 2022