Smoking Cessation Clinical Trial
— CessationOfficial title:
Project 2: Identifying Optimal Smoking Cessation Intervention Components
The goal of this research is to identify the best smoking cessation intervention components to be combined into a state-on-the-art, comprehensive smoking cessation intervention. This research examines the ability of different interventions, provided both prior to and after the quit attempt, to maximize the ability to initially quit and then stay quit. The investigators will be examining six different treatment interventions: pre-quit nicotine patch, pre-quit nicotine gum, pre-quit counseling, post-quit in-person counseling, post-quit phone counseling and duration of post-quit nicotine replacement therapy.
Status | Completed |
Enrollment | 637 |
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; - Agree to attend visits, to respond to coaching calls, and to respond to Interactive Voice Response (IVR) phone prompts; - Plans to remain in the intervention catchment area for at least 12 months; - Currently interested in quitting smoking (defined as would like to try to quit in the next 30 days). - 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 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. - Had 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) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Self-Reported 7-Day Point-Prevalence Abstinence | Self-Reported 7-Day Point-Prevalence Abstinence is a dichotomous outcome with values of 0 and 1 where 0=smoking on one or more of the past 7 days at the assessment endpoint (16 weeks post-quit) and 1=no smoking on any of the past 7 days at the assessment endpoint (i.e., abstinent for the past 7 days); this outcome will be analyzed in a logistic regression analysis model. Note: This abstinence primary outcome replaces latency to relapse (now designated as a secondary outcome) because reviewers of the now-accepted manuscript (at the journal "Addiction") advised us to change the primary outcome to the current week 16 Self-Reported 7-Day Point-Prevalence Abstinence outcome. |
16 weeks post-quit | No |
Secondary | Latency to Relapse | Latency to Relapse during the first 6 months post-quit, with relapse defined as 7 consecutive days of smoking; this outcome will be analyzed in a Cox regression survival analysis model with non-relapsers coded as right-censored. | During the first 6 months post-quit | No |
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