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.
Condition or Disease
- Mood Disorder
- Substance-Related Disorders
- Amphetamine-Related Disorders
Phase
Study Design
Study type: | Interventional |
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Status: | Completed |
Study results: | No Results Available |
Age: | 18 Years to 45 Years (Adult) |
Enrollment: | 16 () |
Funded by: | Other |
Masking |
Clinical Trial Dates
Start date: | Jul 01, 2010 | |
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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
Location
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 |
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Minimum Age: | 18 |
Maximum Age: | 45 |
More Details
NCT Number: | NCT01136278 |
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Other IDs: | EK 353/09 |
Study URL: | https://ClinicalTrials.gov/show/NCT01136278 |
Last updated: Jun 17, 2022