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NCT00365508 · OUTCOME

24-hour Point Prevalence Abstinence at the 6-month Follow up

Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking · Source last updated 2016-03-29

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
6-months

Analysis population: Intent to treat analysis (lost to follow-up = smoker)

Groups in this outcome

Arm I

Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.

Arm II

Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).

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

Analysis denominator · Participants

GroupSource count
Arm I321
Arm II321

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I50Not reportedNot reportedNot reportedNot reported
Arm II35Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Pct Value
    95
    group Description
    Chi-square was used to examine the relationship between treatment arm and 24-hour point prevalence abstinence at 6-months.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    .05
    p Value Comment
    a priori threshold for statistical significance
    statistical Method
    Chi-squared
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Pct Value
    95
    group Description
    Chi-square was used to examine the relationship between treatment arm and 24-hour point prevalence abstinence at 6-months.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    .05
    p Value Comment
    a priori threshold for statistical significance
    statistical Method
    Chi-squared
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        50
      2. group Id
        OG001
        value
        35
denoms
  1. counts
    1. group Id
      OG000
      value
      321
    2. group Id
      OG001
      value
      321
    units
    Participants
groups
  1. description
    Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.
    id
    OG000
    title
    Arm I
  2. description
    Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
    id
    OG001
    title
    Arm II
param Type
NUMBER
population Description
Intent to treat analysis (lost to follow-up = smoker)
reporting Status
POSTED
time Frame
6-months
title
24-hour Point Prevalence Abstinence at the 6-month Follow up
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice