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NCT00666978 · OUTCOME

Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months

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
6 months

What was measured

Salivary cotinine-verified smoking abstinence at 6 months. A cut point of 15 ng/ml was used to differentiate smokers from nonsmokers.

Groups in this outcome

Bupropion Arm

270 African American adults received bupropion (150mg bid) for 7 weeks in addition to health education counseling.

Placebo Arm

270 African American adults received 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
Bupropion Arm270
Placebo Arm270

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bupropion Arm36Not reportedNot reportedNot reportedNot reported
Placebo Arm27Not 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
    0.82
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.35
    estimate Comment
    Raw proportions were used to estimate the verified cessation rate in each group and corresponding odds ratio along with its 95% confidence interval .
    group Description
    Based on our previous studies, sample size was determined a priori assuming a two-sided x2 test with a type I error rate of .05, a power of 80%, and a cotinine-verified abstinence rate of 15% in the placebo group and 25% in the bupropion SR group at week 26, with the assumption that those lost to follow-up would be imputed as smokers.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The x2 test was used to determine whether there was a difference between treatment groups (bupropion SR vs placebo) in verified 7-day point prevalence abstinence at week 26, imputing the missing participants as smokers.
    non Inferiority Type
    SUPERIORITY
    p Value
    .23
    p Value Comment
    All tests of statistical significance were two-sided, and all P values less than .05 were considered statistically significant.
    param Type
    Odds Ratio (OR)
    param Value
    1.39
    statistical Method
    t-test, 2 sided
Complete source fields
analyses
  1. ci Lower Limit
    0.82
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.35
    estimate Comment
    Raw proportions were used to estimate the verified cessation rate in each group and corresponding odds ratio along with its 95% confidence interval .
    group Description
    Based on our previous studies, sample size was determined a priori assuming a two-sided x2 test with a type I error rate of .05, a power of 80%, and a cotinine-verified abstinence rate of 15% in the placebo group and 25% in the bupropion SR group at week 26, with the assumption that those lost to follow-up would be imputed as smokers.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The x2 test was used to determine whether there was a difference between treatment groups (bupropion SR vs placebo) in verified 7-day point prevalence abstinence at week 26, imputing the missing participants as smokers.
    non Inferiority Type
    SUPERIORITY
    p Value
    .23
    p Value Comment
    All tests of statistical significance were two-sided, and all P values less than .05 were considered statistically significant.
    param Type
    Odds Ratio (OR)
    param Value
    1.39
    statistical Method
    t-test, 2 sided
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        36
      2. group Id
        OG001
        value
        27
denoms
  1. counts
    1. group Id
      OG000
      value
      270
    2. group Id
      OG001
      value
      270
    units
    Participants
description
Salivary cotinine-verified smoking abstinence at 6 months. A cut point of 15 ng/ml was used to differentiate smokers from nonsmokers.
groups
  1. description
    270 African American adults received bupropion (150mg bid) for 7 weeks in addition to health education counseling.
    id
    OG000
    title
    Bupropion Arm
  2. description
    270 African American adults received placebo for 7 weeks in addition to health education counseling.
    id
    OG001
    title
    Placebo Arm
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
6 months
title
Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice