Pharmacological Interaction Between Doxazosin and Methylenedioxymethamphetamine (MDMA)

MDMA

Brief Summary

The purpose of this study is to determinate the effect of a pre-treatment with doxazosin, a alpha1-adrenergic receptor blocker, on the pharmacodynamics and pharmacokinetics of 3,4-methylenedioxymethamphetamine (MDMA, "ecstasy"). The investigators hypothesize that doxazosin will attenuate the cardiovascular and subjective response to MDMA.

Intervention / Treatment

  • Drug: 3,4-methylenedioxymethamphetamine
  • Drug: Doxazosin
  • 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: Jul 01, 2011
Primary Completion: Jan 01, 2012
Completion Date: Jan 01, 2012
Study First Posted: Jun 30, 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-adrenergic receptors in the response to MDMA in humans the investigators test the effects of the alpha1-receptor blocker doxazosin on the physiological and subjective effects of MDMA. The investigators use a randomized double-blind placebo-controlled cross-over design with four experimental sessions. doxazosin or placebo will be administered 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 doxazosin will significantly reduce the blood pressure response to MDMA.

Eligibility Criteria

Sex: All
Minimum Age: 18
Maximum Age: 45

More Details

NCT Number: NCT01386177
Other IDs: EK 65/11
Study URL: https://ClinicalTrials.gov/show/NCT01386177
Last updated: Jun 16, 2022