CompletedPhase 1MDMA

Influence of Bupropion on the Effects of MDMA

Sponsored by University Hospital, Basel, Switzerland

NCT ID
NCT01771874
Target Enrollment
16 participants
Start Date
2013-01
Est. Completion
2013-09

About This Study

The purpose of this study is to determinate the effect of a pre-treatment with bupropion, a dopamine and norepinephrine transporter inhibitor, on the pharmacodynamics and pharmacokinetics of 3,4-methylenedioxymethamphetamine (MDMA, "Ecstasy"). The study will provide further understanding of the dopaminergic regulation of mood.

Conditions Studied

HealthySubstance-related Disorders

Interventions

  • MDMA
  • Bupropion
  • Placebo

Eligibility

Age:18 Years - 45 Years
Healthy Volunteers:Yes
View full eligibility criteria
Inclusion Criteria:

* Age between 18 and 45
* Understanding of the German language
* Subjects understand the procedures and the risks associated with the study
* Participants must be willing to adhere to the protocol and sign the consent form
* Participants must be willing to adhere to the protocol and sign the consent form
* Participants must be willing to drink only alcohol-free liquids and no xanthine-containing products(such as coffee, black or green tea, red bull, chocolate) after midnight of the evening before the study session, as well as during the study day
* Participants must be willing not to drive a traffic vehicle within 48 h following MDMA administration
* Women of childbearing potential must have a negative pregnancy test at the beginning of the study and must agree to use an effective form of birth control. Pregnancy tests are repeated before each study session
* Body mass index: 18-27 kg/m2

Exclusion Criteria:

* Chronic or acute medical condition including clinically relevant abnormality in physical exam, laboratory values, or ECG. In particular: Hypertension (\>140/90 mmHg) or Hypotension (SBP\<85 mmHg). Personal or first-grade history of seizures. Cardiac or neurological disorder
* Current or previous psychotic or major affective disorder
* Psychotic or major affective disorder in first-degree relatives
* Prior illicit drug use (except tetrahydrocannabinol (THC)-containing products) more than 5 times or any time within the previous 2 months
* Pregnant or nursing women
* Participation in another clinical trial (currently or within the last 30 days)
* Use of medications that are contraindicated or otherwise interfere with the effects of the study medications (monoamine oxidase inhibitors, antidepressants, sedatives etc.)
* Tobacco smoking

Study Locations (1)

University Hospital Basel
Basel, Canton of Basel-City, Switzerland

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

Find recruiting trials
Data Source
ClinicalTrials.gov

Last updated from source