- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01771874
Influence of Bupropion on the Effects of MDMA
January 20, 2016 updated by: University Hospital, Basel, Switzerland
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Basel-Stadt
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Basel, Basel-Stadt, Switzerland, 4000
- University Hospital Basel
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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.
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per os
Other Names:
125 mg per os, single dose
Other Names:
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive Mood Effects
Time Frame: 24 hours
|
A significant reduction of the (100-mm Visual Analog Scale) positive mood response to MDMA by bupropion.
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24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure(mmHg)during 10 hours
Time Frame: 10 hours
|
10 hours
|
|
Neuroendocrine plasma levels
Time Frame: 10 hours
|
assessed: prolactin, cortisol, epinephrine, norepinephrine, oxytocin, pro-vasopressin, vasopressin, estrogen,and progesterone
|
10 hours
|
Drug plasma levels
Time Frame: 24 hours
|
The plasma concentration of MDMA and bupropion is repetitively assessed
|
24 hours
|
Heart rate (bpm)
Time Frame: 10 hours
|
10 hours
|
|
Body temperature
Time Frame: 10 hours
|
10 hours
|
|
Effects on social cognition (emotion recognition and empathy)
Time Frame: 10 hours
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10 hours
|
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Influence of genetic cytochrome P450 2D6 polymorphisms on the metabolism of MDMA
Time Frame: 24hours
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We will assess the effects of the subjects' genotype and phenotype on MDMA and its metabolites plasma concentrations.
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24hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Matthias E Liechti, MD, MAS, University Hospital, Basel, Switzerland
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Vizeli P, Liechti ME. Oxytocin receptor gene variations and socio-emotional effects of MDMA: A pooled analysis of controlled studies in healthy subjects. PLoS One. 2018 Jun 18;13(6):e0199384. doi: 10.1371/journal.pone.0199384. eCollection 2018.
- Boxler MI, Liechti ME, Schmid Y, Kraemer T, Steuer AE. First Time View on Human Metabolome Changes after a Single Intake of 3,4-Methylenedioxymethamphetamine in Healthy Placebo-Controlled Subjects. J Proteome Res. 2017 Sep 1;16(9):3310-3320. doi: 10.1021/acs.jproteome.7b00294. Epub 2017 Aug 9.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
October 24, 2012
First Submitted That Met QC Criteria
January 16, 2013
First Posted (Estimate)
January 18, 2013
Study Record Updates
Last Update Posted (Estimate)
January 21, 2016
Last Update Submitted That Met QC Criteria
January 20, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Dopamine Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Dopamine Uptake Inhibitors
- Hallucinogens
- Adrenergic Uptake Inhibitors
- Bupropion
- N-Methyl-3,4-methylenedioxyamphetamine
Other Study ID Numbers
- EK 190/12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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