Healthy Clinical Trial
Official title:
Influence of Bupropion on the Effects of MDMA
Verified date | January 2016 |
Source | University Hospital, Basel, Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Swissmedic |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | September 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 45 Years |
Eligibility |
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 |
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Basel | Basel | Basel-Stadt |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Basel, Switzerland |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Positive Mood Effects | A significant reduction of the (100-mm Visual Analog Scale) positive mood response to MDMA by bupropion. | 24 hours | No |
Secondary | Blood pressure(mmHg)during 10 hours | 10 hours | No | |
Secondary | Neuroendocrine plasma levels | assessed: prolactin, cortisol, epinephrine, norepinephrine, oxytocin, pro-vasopressin, vasopressin, estrogen,and progesterone | 10 hours | No |
Secondary | Drug plasma levels | The plasma concentration of MDMA and bupropion is repetitively assessed | 24 hours | No |
Secondary | Heart rate (bpm) | 10 hours | No | |
Secondary | Body temperature | 10 hours | No | |
Secondary | Effects on social cognition (emotion recognition and empathy) | 10 hours | No | |
Secondary | Influence of genetic cytochrome P450 2D6 polymorphisms on the metabolism of MDMA | We will assess the effects of the subjects' genotype and phenotype on MDMA and its metabolites plasma concentrations. | 24hours | No |
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