Smoking Cessation Clinical Trial
— AdherenceOfficial title:
Project 3: Identifying Optimal Strategies of Increasing Smokers' Adherence to Cessation Medications
Many smokers fail to take their smoking cessation medication as recommended. This research is designed to identify treatments that improve the use of cessation medications and to determine whether an increase in medication use results in increased cessation success. This research will also identify treatments that help people stay quit after a quit attempt and will pioneer more efficient research methods.
Status | Completed |
Enrollment | 544 |
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,
McCarthy DE, Piasecki TM, Lawrence DL, Jorenby DE, Shiffman S, Baker TB. Psychological mediators of bupropion sustained-release treatment for smoking cessation. Addiction. 2008 Sep;103(9):1521-33. doi: 10.1111/j.1360-0443.2008.02275.x. — View Citation
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 (52 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 52 Self-Reported 7-Day Point-Prevalence Abstinence. |
Assessed at 52 weeks after target quit day | No |
Secondary | Latency to Relapse | Latency to Relapse during the first 12 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 | Assessed during the first 12 months post-quit after target quit day | No |
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