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Influence of Bupropion on the Effects of MDMA

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ClinicalTrials.gov Identifier: NCT01771874
Recruitment Status : Completed
First Posted : January 18, 2013
Last Update Posted : January 21, 2016
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Substance-related Disorders Drug: MDMA Drug: Bupropion Drug: Placebo Phase 1

Detailed Description:
3,4-methylenedioxymethamphetamine (MDMA, "ecstasy") is widely used by young people for its euphoric effects. MDMA releases serotonin (5-HT), dopamine (DA), and norepinephrine (NE). 5-HT release mainly contributes to the subjective effects of MDMA whereas NE release is involved in the cardiovascular and psychostimulant effects of MDMA. DA mediates the reinforcing addiction-related effects of drugs of abuse but it is unclear whether DA contributes to the acute effects of MDMA in humans. To determine the role of DA transporter-mediated DA release in the acute response to MDMA in humans the investigators test the effects of the DA transporter inhibitor bupropion on the physiological and subjective effects of MDMA. The investigators use a randomized double-blind placebo-controlled cross-over design with four experimental sessions. Bupropion 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 bupropion reduces the MDMA-induced increase in positive mood.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Influence of Bupropion on the Effects of MDMA
Study Start Date : January 2013
Actual Primary Completion Date : May 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: MDMA, bupropion, placebo
Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 1 arm but two (actually 4) treatment conditions in the same subject. The four treatment conditions are placebo-placebo, bupropion-placebo, placebo-MDMA, and bupropion-MDMA.
Drug: MDMA
125 mg per os, single dose
Other Names:
  • Ecstasy
  • 3,4-Methylenedioxymethamphetamine

Drug: Bupropion
Bupropion will be administered in a dose of 150mg (Wellbutrin XR) once-daily in the morning for three days followed by 300mg (2x150mg) for 4 days before the test day. On the test day, a final dose of 300mg will administered 2 hours before the administration of MDMA 125 mg or placebo.
Other Names:
  • Wellbutrin XR
  • Zyban

Drug: Placebo
per os
Other Name: capsules containing manitol looking identical to MDMA or bupropion

Primary Outcome Measures :
  1. Positive Mood Effects [ Time Frame: 24 hours ]
    A significant reduction of the (100-mm Visual Analog Scale) positive mood response to MDMA by bupropion.

Secondary Outcome Measures :
  1. Blood pressure(mmHg)during 10 hours [ Time Frame: 10 hours ]
  2. Neuroendocrine plasma levels [ Time Frame: 10 hours ]
    assessed: prolactin, cortisol, epinephrine, norepinephrine, oxytocin, pro-vasopressin, vasopressin, estrogen,and progesterone

  3. Drug plasma levels [ Time Frame: 24 hours ]
    The plasma concentration of MDMA and bupropion is repetitively assessed

  4. Heart rate (bpm) [ Time Frame: 10 hours ]
  5. Body temperature [ Time Frame: 10 hours ]
  6. Effects on social cognition (emotion recognition and empathy) [ Time Frame: 10 hours ]
  7. Influence of genetic cytochrome P450 2D6 polymorphisms on the metabolism of MDMA [ Time Frame: 24hours ]
    We will assess the effects of the subjects' genotype and phenotype on MDMA and its metabolites plasma concentrations.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771874

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University Hospital Basel
Basel, Basel-Stadt, Switzerland, 4000
Sponsors and Collaborators
University Hospital, Basel, Switzerland
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Principal Investigator: Matthias E Liechti, MD, MAS University Hospital, Basel, Switzerland
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01771874    
Other Study ID Numbers: EK 190/12
First Posted: January 18, 2013    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: January 2016
Keywords provided by University Hospital, Basel, Switzerland:
Mechanism of action of MDMA
Interaction study
Effect of MDMA and bupropion on emotions
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Serotonin Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents