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.
|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|
- 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.
- 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.
|Study Start Date:||January 2013|
|Study Completion Date:||September 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
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.
125 mg per os, single dose
Other Names: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:Drug: Placebo
Other Name: capsules containing manitol looking identical to MDMA or bupropion
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01771874
|University Hospital Basel|
|Basel, Basel-Stadt, Switzerland, 4000|
|Principal Investigator:||Matthias E Liechti, MD, MAS||University Hospital, Basel, Switzerland|