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Influence of Bupropion on the Effects of MDMA

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01771874
First received: October 24, 2012
Last updated: October 21, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Healthy
Substance-related Disorders
Drug: MDMA
Drug: Bupropion
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Influence of Bupropion on the Effects of MDMA

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Positive Mood Effects [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    A significant reduction of the (100-mm Visual Analog Scale) positive mood response to MDMA by bupropion.


Secondary Outcome Measures:
  • Blood pressure(mmHg)during 10 hours [ Time Frame: 10 hours ] [ Designated as safety issue: No ]
  • Neuroendocrine plasma levels [ Time Frame: 10 hours ] [ Designated as safety issue: No ]
    assessed: prolactin, cortisol, epinephrine, norepinephrine, oxytocin, pro-vasopressin, vasopressin, estrogen,and progesterone

  • Drug plasma levels [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    The plasma concentration of MDMA and bupropion is repetitively assessed

  • Heart rate (bpm) [ Time Frame: 10 hours ] [ Designated as safety issue: No ]
  • Body temperature [ Time Frame: 10 hours ] [ Designated as safety issue: No ]
  • Effects on social cognition (emotion recognition and empathy) [ Time Frame: 10 hours ] [ Designated as safety issue: No ]
  • Influence of genetic cytochrome P450 2D6 polymorphisms on the metabolism of MDMA [ Time Frame: 24hours ] [ Designated as safety issue: No ]
    We will assess the effects of the subjects' genotype and phenotype on MDMA and its metabolites plasma concentrations.


Enrollment: 16
Study Start Date: January 2013
Study Completion Date: September 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771874

Locations
Switzerland
University Hospital Basel
Basel, Basel-Stadt, Switzerland, 4000
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Matthias E Liechti, MD, MAS University Hospital, Basel, Switzerland
  More Information

No publications provided

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01771874     History of Changes
Other Study ID Numbers: EK 190/12
Study First Received: October 24, 2012
Last Updated: October 21, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
MDMA
pharmacokinetics
pharmacodynamics
emotions
Mechanism of action of MDMA
Interaction study
Effect of MDMA and bupropion on emotions

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Bupropion
N-Methyl-3,4-methylenedioxyamphetamine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Hallucinogens
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014