Pharmacogenetics of Bupropion Metabolism
The aim of the investigators research is to see if variants in a particular gene (named CYP2B6) affect how the body metabolizes (breaks down) certain medications, including the drug bupropion. Bupropion is widely used in the treatment of depression and for helping people quit smoking. Genes are portions of DNA that code for particular proteins in the body. The investigators are studying the gene that codes for a protein called CYP2B6. Differences in the structure of the gene are called variants and may mean that a person metabolizes a drug faster or slower than a person with a different variant.
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||Pharmacogenetics of Bupropion Metabolism|
- Area under the plasma concentration versus time curve (AUC) for bupropion [ Time Frame: 0, 4, 8, 12, 16,24 hours from steady state ] [ Designated as safety issue: No ]Subjects took bupropion daily for 7 days as outpatients prior to the study day to allow them to reach steady state concentrations of bupropion and its metabolites. The time frame shown is measured from 08:00 on the morning of inpatient admission.
|Study Start Date:||June 2008|
|Study Completion Date:||November 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Bupropion is widely used in the treatment of depression and for smoking cessation. It's most abundant metabolite, hydroxybupropion, may be responsible for most of the therapeutic effect of bupropion under conditions of long term dosing. Because the primary enzyme involved in metabolism of bupropion to hydroxybupropion is the liver enzyme CYP2B6, we propose to study the effect of different CYP2B6 genotypes on the metabolism of bupropion. These data will guide the use of genotypes as a surrogate for measuring drug blood levels in studying genetic determinants of outcomes for bupropion treatment.
A minimum of Forty-four subjects with 4 different CYP2B6 genotypes will participate in a 7-day study in which they take bupropion as outpatients for 6 days (to achieve steady state drug levels) and then come to the San Francisco General Hospital (SFGH) Clinical Research Center for a 1-day admission during which multiple blood and urine samples will be collected for pharmacokinetic analysis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00791869
|United States, California|
|San Francisco General Hospital-Clinical Research Ward|
|San Francisco, California, United States, 94110|
|Principal Investigator:||Neal L Benowitz, MD||University of California, San Francisco|