Clinical TrialHealthy VolunteersMDMAPlaceboCompleted

Influence of Bupropion on the Effects of MDMA

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.

Target Enrollment
16 participants
Study Type
Phase I interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomised, double-blind, placebo-controlled crossover in 16 healthy volunteers testing the effect of bupropion pre-treatment on acute physiological and subjective responses to MDMA.

Bupropion XR given for 7 days (150 mg x3 days, then 300 mg x4 days) with a single 300 mg dose 2 hours before MDMA 125 mg or placebo; outcomes include repeated subjective measures, cardiovascular responses, and MDMA pharmacokinetics.

Study Protocol

Preparation

sessions

Dosing

4 sessions

Integration

sessions

Study Arms & Interventions

MDMA ± bupropion

experimental

Randomised, double-blind, within-subject crossover with four treatment conditions (placebo-placebo; bupropion-placebo; placebo-MDMA; bupropion-MDMA).

Interventions

  • MDMA125 mg
    via Oral• single dose

    MDMA 125 mg per os.

  • Compound300 mg
    via Oral• 7-day course with single pre-dose

    Bupropion XR: 150 mg qd x3 then 300 mg qd x4; 300 mg given 2 h before MDMA/placebo on test day.

  • Placebo
    via Oral• single dose

    Placebo capsules matching MDMA or bupropion.

Participants

Ages
18 – 45
Sexes
Male & Female

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 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 Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment16 participants
  • Timeline
    Start: 2013-01-01
    End: 2013-01-09
  • Compounds
    MDMAPlacebo
  • Topic
    Healthy Volunteers

Locations

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

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