Interaction Between Reboxetine and 3,4-Methylenedioxymethamphetamine: Pharmacodynamics (PD) and Pharmacokinetics (PK)

MDMA

Brief Summary

MDMA releases dopamine, serotonin, and norepinephrine in the brain. Serotonin uptake inhibitors have been shown to interact with 3,4-Methylenedioxymethamphetamine (MDMA) and to decrease its psychoactive and cardiovascular stimulant effects. This finding indicates that MDMA acts in part by releasing serotonin through the serotonin uptake site. However, in vitro studies show that MDMA binds more potently to the norepinephrine uptake site that to the the serotonin or dopamine uptake transporter. In addition, norepinephrine uptake site blockers such antidepressant drugs attenuate some of the behavioral effects of MDMA in animals. These preclinical data indicate that norepinephrine may also contribute to the response to MDMA in humans. To test this hypothesis this study evaluates the interacting effects of the selective norepinephrine transporter inhibitor reboxetine on the subjective and cardiovascular stimulant effects of MDMA in healthy volunteers.

Intervention / Treatment

  • Drug: MDMA
  • Drug: Reboxetine, 8 mg
  • 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: Apr 01, 2009
Primary Completion: Dec 01, 2009
Completion Date: Mar 01, 2010
Study First Posted: Apr 23, 2009
Results First Posted: Aug 30, 2020
Last Updated: Jan 25, 2013

Sponsors / Collaborators

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

Location

Basel, Basel-Stadt, Switzerland

The study will use a randomized double-blind cross-over design with four experimental sessions. Reboxetine (8 mg) or placebo will be administered the night before the experimental session and 1 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.

We hypothesize that the highly selective norepinephrine uptake inhibitor reboxetine will attenuate subjective and especially heart rate and blood pressure responses to MDMA. Such a result would indicate that norepinephrine is critically involved in the pharmacology of MDMA and may provide helpful in the use and development of treatments for Ecstasy intoxications.

Eligibility Criteria

Sex: All
Minimum Age: 18
Maximum Age: 45

More Details

NCT Number: NCT00886886
Other IDs: EKBB373/08
Study URL: https://ClinicalTrials.gov/show/NCT00886886
Last updated: Jun 17, 2022