NCT00791869

Completed

Pharmacogenetics of Bupropion Metabolism

University of California, San Francisco Source

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Other study identifiers

Sponsor study identifier

H133-31868

Secondary identifiers

U01DA020830

NIH

Study Type

observational

Actual enrollment (reported)

43

Locations

1 country

Sites

1

Timeline

Study Start

June 2008

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2010

Actual (reported)

Study Completion

November 2010

Actual (reported)

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. 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 43 participants
Study completion date: November 2010
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
June 2008
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
November 14, 2008
Actual (reported)
First Posted
November 17, 2008
Actual (reported)
Primary Completion
March 2010
Actual (reported)
Study Completion
November 2010
Actual (reported)

Last Updated: May 22, 2013
Status Verified: May 2013
Last Update Submitted: May 20, 2013

Conditions

Metabolism Pharmacokinetics

Keywords

bupropionsmokingpharmacokineticsPharmacokinetics of bupropion

Outcome Measures

Primary Outcomes (1)

Area under the plasma concentration versus time curve (AUC) for bupropion
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.
0, 4, 8, 12, 16,24 hours from steady state

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Healthy subjects with selected CYP2B6 genotypes.

You may qualify if:

Age: 18 - 65 years

Sponsors & Collaborators

University of California, San Francisco
Otherlead

Study Sites (1)

San Francisco General Hospital-Clinical Research Ward

San Francisco, California, 94110, United States

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

Neal L Benowitz, MD
University of California, San Francisco
PRINCIPAL INVESTIGATOR

Enrollment

43 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: CROSS SECTIONAL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 14, 2008

First Posted

November 17, 2008

Study Start

June 2008

Date type not reported

This date has not been verified as actual or estimated.

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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
Drug/alcohol use: no alcohol abuse by history, no regular recreational drug use, any intravenous drug abuse, recent history of Treatment program

Contact the study team to confirm eligibility.

Primary Completion

March 2010

Actual (reported)

Study Completion

November 2010

Actual (reported)

Last Updated

May 22, 2013

Record last verified: 2013-05

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT00791869
Data provider: ClinicalTrials.gov
Source updated: 2013-05-22
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:36:40 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations