UW Quitting Using Intensive Treatment Study (QUITS)
- Conditions
- Tobacco Dependence
- Interventions
- Registration Number
- NCT03176784
- Lead Sponsor
- University of Wisconsin, Madison
- Brief Summary
This research will determine whether two highly promising modifications to varenicline treatment (i.e. use of a nicotine patch adjuvant and extended 24-week duration) produce superior smoking outcomes when they are either used together or alone. Despite their promise, the proposed modifications have never been experimentally evaluated relative to standard varenicline pharmacotherapy. Thus, this innovative research will produce novel evidence regarding how best to help smokers quit, and thereby address the leading cause of preventable mortality and morbidity related to cardiovascular and pulmonary diseases.
- Detailed Description
Building on our recent NHLBI-funded publication in JAMA (see references below) that described the modest effectiveness of varenicline pharmacotherapy, this study will use a 2 X 2 factorial design to evaluate two different medication use strategies on their ability to markedly enhance varenicline effectiveness in a large cohort of current smokers. Smokers (N=1000) will be randomly assigned to one of two levels for each of two factors: 1) an Adjuvant factor (varenicline + placebo patch versus varenicline + nicotine patch), and 2) a Duration factor (12 versus 24 weeks of active medication). Thus, this factorial design yields a "standard" varenicline treatment (12 weeks of active varenicline and 12 weeks of placebo varenicline + 24 weeks of placebo patch), and 3 enhanced treatments: 1) 12 weeks of active varenicline and 12 weeks of placebo varenicline + 24 weeks of active patch, 2) 24-weeks of active varenicline + 24 weeks of placebo patch, and 3) 24 weeks of active varenicline + 24 weeks of active patch.
Both treatment modifications, longer duration therapy and use of a nicotine replacement therapy (NRT) adjuvant, have produced some quite promising effects. However, in both cases these modifications have been little researched, their effects are not consistently positive, and they have not been implemented in a potentially optimal manner. We will implement each modification in an innovative manner designed to enhance its effectiveness. In addition, all participants will be given counseling that supports adherent medication use and that is readily translatable to healthcare settings. The scientific rigor of this work will be enhanced by the use of placebo medication, a large sample, and a factorial design. The latter will allow us to test both the main and interaction effects of the experimental factors. We will also be able to compare each enhanced treatment with standard 12-week varenicline-only therapy to determine whether any of these medication use strategies significantly enhances treatment effectiveness.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1251
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Varenicline + Patch Standard Duration Varenicline Standard Condition Varenicline: 0.5 mg pill once daily (QD) on Days -7 to -5; 0.5 mg pill twice daily (BID) Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID Standard Condition Nicotine Patches: Patches (Nicotine): 14 mg Patches for 2 weeks prequit and then 10 weeks post-quit, then 7 mg patches for Weeks 11 and 12; Placebo patches weeks 13-24 Varenicline Only Standard Duration Varenicline Standard Condition Varenicline: 0.5 mg pill QD on Days -7 to -5; 0.5 mg pill BID Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID Standard Condition Placebo Patches: Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit Varenicline Only Standard Duration Placebo Patch Standard Condition Varenicline: 0.5 mg pill QD on Days -7 to -5; 0.5 mg pill BID Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID Standard Condition Placebo Patches: Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit Varenicline Only Standard Duration Placebo Pill Standard Condition Varenicline: 0.5 mg pill QD on Days -7 to -5; 0.5 mg pill BID Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID Standard Condition Placebo Patches: Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit Varenicline Only Extended Duration Placebo Patch Extended Condition Varenicline: 0.5 mg pill QD on Days -7 to -5, 0.5 mg pill BID Days -4 to -1, and 1 mg pill BID Days 1 to Week 22 Extended Condition Placebo Patches: Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit Varenicline + Patch Standard Duration Nicotine patch Standard Condition Varenicline: 0.5 mg pill once daily (QD) on Days -7 to -5; 0.5 mg pill twice daily (BID) Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID Standard Condition Nicotine Patches: Patches (Nicotine): 14 mg Patches for 2 weeks prequit and then 10 weeks post-quit, then 7 mg patches for Weeks 11 and 12; Placebo patches weeks 13-24 Varenicline + Patch Standard Duration Placebo Patch Standard Condition Varenicline: 0.5 mg pill once daily (QD) on Days -7 to -5; 0.5 mg pill twice daily (BID) Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID Standard Condition Nicotine Patches: Patches (Nicotine): 14 mg Patches for 2 weeks prequit and then 10 weeks post-quit, then 7 mg patches for Weeks 11 and 12; Placebo patches weeks 13-24 Varenicline + Patch Standard Duration Placebo Pill Standard Condition Varenicline: 0.5 mg pill once daily (QD) on Days -7 to -5; 0.5 mg pill twice daily (BID) Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID Standard Condition Nicotine Patches: Patches (Nicotine): 14 mg Patches for 2 weeks prequit and then 10 weeks post-quit, then 7 mg patches for Weeks 11 and 12; Placebo patches weeks 13-24 Varenicline + Patch Extended Duration Nicotine patch Extended Condition Varenicline: 0.5 mg pill QD on Days -7 to -5, 0.5 mg pill BID Days -4 to -1, and 1 mg pill BID Days 1 to Week 22 Extended Condition Nicotine Patches: 14 mg Patches for 2 weeks prequit and then weeks 1-22 post-quit, then 7 mg patches for Weeks 23 and 24 post-quit. Varenicline + Patch Extended Duration Varenicline Extended Condition Varenicline: 0.5 mg pill QD on Days -7 to -5, 0.5 mg pill BID Days -4 to -1, and 1 mg pill BID Days 1 to Week 22 Extended Condition Nicotine Patches: 14 mg Patches for 2 weeks prequit and then weeks 1-22 post-quit, then 7 mg patches for Weeks 23 and 24 post-quit. Varenicline Only Extended Duration Varenicline Extended Condition Varenicline: 0.5 mg pill QD on Days -7 to -5, 0.5 mg pill BID Days -4 to -1, and 1 mg pill BID Days 1 to Week 22 Extended Condition Placebo Patches: Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit
- Primary Outcome Measures
Name Time Method 52-Week Point-Prevalence Abstinence Assessed 52 weeks after quit date Biochemically-confirmed self-reported total abstinence from any cigarette use (even a single puff) for the seven days preceding the target follow-up day, confirmed with an exhaled carbon monoxide reading of less than or equal to 5 ppm.
- Secondary Outcome Measures
Name Time Method 23-Week Point-Prevalence Abstinence Assessed 23 weeks after quit date Biochemically confirmed self-reported total abstinence from any cigarette use (even a single puff) for the seven days preceding the target follow-up day, confirmed with an exhaled carbon monoxide reading of less than or equal to 5 ppm.
52-Week Prolonged Abstinence Assessed 52 weeks after quit date Biochemically confirmed self-reported total abstinence from any cigarette use (even a single puff) from week 2 post-quit through week 52 post-quit, confirmed with an exhaled carbon monoxide reading of less than or equal to 5 ppm.
23-Week Prolonged Abstinence Assessed 23 weeks after quit date Biochemically confirmed self-reported total abstinence from any cigarette use (even a single puff) from week 2 post-quit through week 23 post-quit, confirmed with an exhaled carbon monoxide reading of less than or equal to 5 ppm.
Trial Locations
- Locations (2)
UW Center for Tobacco Research and Intervention
🇺🇸Milwaukee, Wisconsin, United States
UW Center For Tobacco Research and Intervention
🇺🇸Madison, Wisconsin, United States