Smoking Cessation Clinical Trial
— MotivationOfficial title:
Identifying Optimal, Translatable Smoking Cessation Intervention Components
At any given point in time, most smokers are not interested in making a serious quit attempt. Data suggest that 30% of smokers have no plans to quit, 30% plan to quit at some future date, 30% plan to quit in the next 6 months, and about 10% plan to quit in the next month. While ~40% of smokers make a quit attempt each year, only about 4-6% of those achieve long-term success. This means that of the more than 60 million Americans who smoke, only 1 million are able to quit each year. If we could double the number of quit attempts and maintain comparable success rates, we could double the number of individuals who will benefit from living smoke free lives. These observations underscore the need to develop interventions that increase smokers' motivation or willingness to make quit attempts, and that also increase the rate of success among those who attempt to quit. The overall goal of this proposed experiment is to identify effective interventions aimed at increasing motivation for smoking cessation, increasing quit attempts, and increasing rates of cessation success. Interventions that will be tested include: use of nicotine gum, use of nicotine patches, motivational interviewing, and smoking reduction counseling. At minimum, all participants will complete surveys about their smoking behavior that might increase their motivation to eventually quitting smoking.
Status | Completed |
Enrollment | 517 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria: - 18 years of age or older; - Report smoking at least 5 cigarettes per day for the previous 6 months; - Able to read and write English; - Available to take one phone call per week; - Not currently interested in quitting smoking (defined as would not like to try to quit in the next 30 days), - Plans to remain in the intervention catchment area for at least 12 months - All women of childbearing potential will be required to agree to use an acceptable method of birth control to prevent pregnancy during the study. Exclusion Criteria: - Currently taking bupropion, Wellbutrin, chantix or varenicline (current use of NRT is not exclusionary if the participant agrees to use only study medication for the duration of the study); - Study candidate is a pregnant, trying to get pregnant, or nursing; - A history of psychosis or bipolar disorder - A history of skin or allergic reactions while using a nicotine patch. - Study candidate reports having a heart attack, stroke, or abnormal electrocardiogram within the past 4 weeks. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison | Aurora Health Care, Dean Health System, Mercy Health System, Wisconsin, National Cancer Institute (NCI), University of Illinois at Chicago |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent Change in Cigarettes Smoked Per Day (CPD) | Percent Change in Cigarettes Smoked Per Day (CPD) is computed as the percent change in self-reported cigarettes smoked per day at the assessment endpoint relative to baseline CPD; this outcome will be analyzed in a linear regression analysis model. Note: This Percent change in Cigarettes Smoked Per Day (CPD) primary outcome replaces "average number of cigarettes per day in the past week" (now designated as a secondary outcome) because the percent change metric allows better comparison with prior research in this area and the results for both outcomes are highly similar. |
Assessed at week 26 relative to baseline CPD. | No |
Secondary | Average Number of Cigarettes Per Day in the Past Week. | Assessed at baseline and week 26. | No |
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