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NCT00666978 · OUTCOME

Number of Slow and Fast Metabolizers by Metabolite Ratio

Health Education Counseling With or Without Bupropion in Helping African Americans Stop Smoking · Source last updated 2017-11-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Weeks 0

What was measured

Analyzed CYP2A6 by activity, called the nicotine metabolite ratio using a split between slow and fast metabolism at 0.31. The variants present in people in the slow genotype group include \*17, \*20, \*23,\*27, \*35, \*9, \*2, \*25, \*26, and \*4. The fast metabolizers have none of the variant alleles tested. Blood samples were collected for 3HC/COT ratio at Week 0.

Analysis population: This variant is related to nicotine metabolism and was collected from all study participants but not analyzed by study arm as it does not relate to the study medication. Data pre-specified to be collected and reported as a single arm.

Groups in this outcome

All Study Participants

All study participants were African American adults and received either bupropion (150mg bid) for 7 weeks in addition to health education counseling or placebo for 7 weeks in addition to health education counseling.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
All Study Participants450

Reported measurements

Fast Metabolizers by Nicotine Metabolite Ratio
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Study Participants236Not reportedNot reportedNot reportedNot reported
Slow Metabolizers by Nicotine Metabolite Ratio
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Study Participants214Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.95
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.99
    estimate Comment
    This reflects Week 7.
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.0022
    p Value Comment
    This reflects Week 7.
    param Type
    Odds Ratio (OR)
    param Value
    0.97
    statistical Method
    Regression, Logistic
Complete source fields
analyses
  1. ci Lower Limit
    0.95
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.99
    estimate Comment
    This reflects Week 7.
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.0022
    p Value Comment
    This reflects Week 7.
    param Type
    Odds Ratio (OR)
    param Value
    0.97
    statistical Method
    Regression, Logistic
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        236
    title
    Fast Metabolizers by Nicotine Metabolite Ratio
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        214
    title
    Slow Metabolizers by Nicotine Metabolite Ratio
denoms
  1. counts
    1. group Id
      OG000
      value
      450
    units
    Participants
description
Analyzed CYP2A6 by activity, called the nicotine metabolite ratio using a split between slow and fast metabolism at 0.31. The variants present in people in the slow genotype group include \*17, \*20, \*23,\*27, \*35, \*9, \*2, \*25, \*26, and \*4. The fast metabolizers have none of the variant alleles tested. Blood samples were collected for 3HC/COT ratio at Week 0.
groups
  1. description
    All study participants were African American adults and received either bupropion (150mg bid) for 7 weeks in addition to health education counseling or placebo for 7 weeks in addition to health education counseling.
    id
    OG000
    title
    All Study Participants
param Type
COUNT_OF_PARTICIPANTS
population Description
This variant is related to nicotine metabolism and was collected from all study participants but not analyzed by study arm as it does not relate to the study medication. Data pre-specified to be collected and reported as a single arm.
reporting Status
POSTED
time Frame
Weeks 0
title
Number of Slow and Fast Metabolizers by Metabolite Ratio
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice