Pharmacological Interaction Between Carvedilol and Methylenedioxymethamphetamine (MDMA)

MDMA

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.

Intervention / Treatment

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

Condition or Disease

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

Phase

Study Design

Study type: Interventional
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: Jan 01, 2011
Primary Completion: May 01, 2011
Completion Date: May 01, 2011
Study First Posted: Jan 05, 2011
Results First Posted: Aug 30, 2020
Last Updated: Dec 11, 2018

Sponsors / Collaborators

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

Location

Basel, Basel-Stadt, Switzerland

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.

Eligibility Criteria

Sex: All
Minimum Age: 18
Maximum Age: 45

More Details

NCT Number: NCT01270672
Other IDs: EK 218/10
Study URL: https://ClinicalTrials.gov/show/NCT01270672
Last updated: Jun 17, 2022