Pharmacogenetics of Bupropion Metabolism
Completed
Conditions studied: Metabolism, Pharmacokinetics
In brief
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.
Key facts
- Study ID
- NCT00791869
- Run by
- University of California, San Francisco
- People needed
- 43
- Starts
- 2008-06-01
- Expected to finish
- 2010-11-01
- Last updated by the study team
- 2013-05-22
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age: 18 - 65 years
- Gender: Either
- Ethnic/Racial Group: Any
- Smoking Status: Both smokers and non-smokers are eligible
- CYP2B6 genotype: CYP2B6 *1/*1 (11 subjects); *4, *5 and *6 alleles (11 each) [44 subjects total] Up to 15 additional subjects may be studied with genotypes that do not fall into one of the primary groups.
You may not qualify if…
- Medical: Exclude most any chronic illness requiring regular medication.
- Cardiac: History of angina or other serious heart disease; ECG abnormalities on screening.
- Hypertension: screening visit BP of 150/95 or more after 5 min rest
- Respiratory: Asthma - acceptable if in remission, otherwise exclude.
- Systemic: "Morbidly Obese" Exclude if BMI > 35
- Diabetes: By history
- Chronic Active Hepatitis: By history; elevated Liver Function Tests
- Cancers: By history
- Pregnancy/breastfeeding: By history; positive urine pregnancy test
- Seizures: individuals with a history of seizures will be excluded (risk factor for bupropion-induced seizures)
- Eating Disorders: individuals with a history of eating disorders will be excluded (risk factor for bupropion-induced seizures)
- Head Trauma: individuals with a history of head trauma will be excluded (risk factor for bupropion-induced seizures)
- Other tobacco users (pipe, cigar, chewing tobacco, snuff users
- Medications/Supplements: General Exclusion = "any regular oral and/or prescription drug use"; current use of oral contraceptives or other female hormones.
- Drug/alcohol use: no alcohol abuse by history, no regular recreational drug use, any intravenous drug abuse, recent history of Treatment program
Where it is running
- San Francisco General Hospital-Clinical Research Ward — San Francisco, California, United States
Full record on ClinicalTrials.gov
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