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
|Condition or disease||Intervention/treatment||Phase|
|Healthy Substance-related Disorders||Drug: MDMA Drug: Bupropion Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|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|
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
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 Name: capsules containing manitol looking identical to MDMA or bupropion
- Positive Mood Effects [ Time Frame: 24 hours ]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 ]
- Neuroendocrine plasma levels [ Time Frame: 10 hours ]assessed: prolactin, cortisol, epinephrine, norepinephrine, oxytocin, pro-vasopressin, vasopressin, estrogen,and progesterone
- Drug plasma levels [ Time Frame: 24 hours ]The plasma concentration of MDMA and bupropion is repetitively assessed
- Heart rate (bpm) [ Time Frame: 10 hours ]
- Body temperature [ Time Frame: 10 hours ]
- Effects on social cognition (emotion recognition and empathy) [ Time Frame: 10 hours ]
- 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.
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
|University Hospital Basel|
|Basel, Basel-Stadt, Switzerland, 4000|
|Principal Investigator:||Matthias E Liechti, MD, MAS||University Hospital, Basel, Switzerland|