Status:
COMPLETED
Pharmacogenetics of Bupropion Metabolism
Lead Sponsor:
University of California, San Francisco
Conditions:
Metabolism
Pharmacokinetics
Eligibility:
All Genders
18-65 years
Brief Summary
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. Bupropi...
Detailed Description
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 u...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00791869
Start Date
June 1 2008
End Date
November 1 2010
Last Update
May 22 2013
Active Locations (1)
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1
San Francisco General Hospital-Clinical Research Ward
San Francisco, California, United States, 94110