Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
270 participants
INTERVENTIONAL
2012-12-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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Cognitive/Motivational Intervention Group
This arm of the project will address the following questions:
After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?
After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?
Cognitive / Motivational Individual Sessions
Cognitive Motivational subjects will receive four evidence-based preparatory interventions (motivational interviewing, smoking reduction, practice quit attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each).
Nicotine Patch
Cognitive Motivational subjects will be asked to take one 21 mg patch/day for 4 weeks.
Group Curriculum
Everyone to be put into the experimental or active comparator group will attend 2 group meetings over two weeks each of which lasts 40 minutes. Experience with the Kicking Butts program indicates that this duration is well tolerated by this population. The content of these two group meetings is based on the Kicking Butts program. The Kicking Butts program was initially developed as a cessation intervention, but consistent with the literature about the need to prepare this population to make a quit attempt, has evolved to emphasize preparation for quitting. Topics addressed include the health consequences of smoking, reasons to quit and methods of quitting.
Attention Control Group
This arm of the project will address the following question:
After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate that those who are in the experimental treatment group?
After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Cognitive/Motivational Intervention Group?
Attention Control Individual Sessions
Attention control subjects will receive four placebo individual sessions (25-30 minutes each). The session content will reemphasize group discussion of the personal health risks from smoking.
Group Curriculum
Everyone to be put into the experimental or active comparator group will attend 2 group meetings over two weeks each of which lasts 40 minutes. Experience with the Kicking Butts program indicates that this duration is well tolerated by this population. The content of these two group meetings is based on the Kicking Butts program. The Kicking Butts program was initially developed as a cessation intervention, but consistent with the literature about the need to prepare this population to make a quit attempt, has evolved to emphasize preparation for quitting. Topics addressed include the health consequences of smoking, reasons to quit and methods of quitting.
Motivated Smokers Comparison Group
This arm of the project will address the following question:
Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?
Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?
Participants will not receive any intervention but will be consented and enrolled into this group and assessed for utilization of the tobacco quit line services.
No interventions assigned to this group
Interventions
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Cognitive / Motivational Individual Sessions
Cognitive Motivational subjects will receive four evidence-based preparatory interventions (motivational interviewing, smoking reduction, practice quit attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each).
Attention Control Individual Sessions
Attention control subjects will receive four placebo individual sessions (25-30 minutes each). The session content will reemphasize group discussion of the personal health risks from smoking.
Nicotine Patch
Cognitive Motivational subjects will be asked to take one 21 mg patch/day for 4 weeks.
Group Curriculum
Everyone to be put into the experimental or active comparator group will attend 2 group meetings over two weeks each of which lasts 40 minutes. Experience with the Kicking Butts program indicates that this duration is well tolerated by this population. The content of these two group meetings is based on the Kicking Butts program. The Kicking Butts program was initially developed as a cessation intervention, but consistent with the literature about the need to prepare this population to make a quit attempt, has evolved to emphasize preparation for quitting. Topics addressed include the health consequences of smoking, reasons to quit and methods of quitting.
Eligibility Criteria
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Inclusion Criteria
* not willing to make a quit attempt
* willingness to use the nicotine patch
* plans to remain in the area for the next five four months.
Exclusion Criteria
* previous serious skin reaction or other allergic reaction to using the nicotine patch
* stroke, heart attack or abnormal electrocardiogram in past four weeks
* pregnancy, plans to get pregnant or nursing
* exclusive use of other tobacco products (non-smoker tobacco user)
* having a court-ordered guardian, or an activated power of attorney for health or observation by researchers during the consent procedure that suggests diminished decision making capacity
18 Years
99 Years
ALL
No
Sponsors
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University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Bruce Christiansen, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin School of Medicine and Public Health, Center for Tobacco Research and Intervention
Locations
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University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Madison, Wisconsin, United States
Countries
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Related Links
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University of Wisconsin School of Medicine and Public Health, Center for Tobacco Research and Intervention Website
Other Identifiers
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2011-0604
Identifier Type: -
Identifier Source: org_study_id