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Cessation Screening Project

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Cessation Screening Project

This project will use the Multiphase Optimization Strategy (MOST) to guide the development of optimized treatment strategies for the two most effective smoking cessation medications (Combination Nicotine Replacement [C-NRT] and varenicline). The investigators will recruit daily smokers from primary care to participate in a fully crossed, 2x2x2x2 factorial experiment (N=608) that evaluates 4 different factors: 1) Medication Type (Varenicline vs. C-NRT), 2) Preparation Medication (4 Weeks vs. Standard), 3) Medication Duration (Extended [24 weeks] vs. Standard [12 weeks]); and 4) Counseling Modality (three, 15-20 minute sessions conducted In-Person vs. Phone). Participants will complete baseline assessments and then assessments of smoking status, treatment use, side effects, potential treatment mechanisms (e.g., withdrawal, self-efficacy) at Weeks 6, 12, 26 and 52 and Months 18 and 24 post-target quit day. These data will be used to examine the main and interactive effects of these four factors on various outcomes, with biochemically confirmed 12-month abstinence serving as the primary outcome. These data will also be used to determine which factors and combinations of factors are most effective with regard to 12-month biochemically confirmed abstinence and cost, thereby identifying optimized varenicline and C-NRT treatments, with each developed to yield especially great benefit. These optimized treatments will then be tested in the Optimized Care Project. The investigators will also examine the relative effects of each medication on particular outcomes (e.g., 12-month abstinence).

common.study.values.location

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common.study.values.methods

Pharmaceutical medication involved common.study.methods.has-drugs-yes
Patients and healthy individuals accepted common.study.methods.is-healthy-no

Drug - Preparation and Standard Duration Varenicline

15 weeks of varenicline starting 4 weeks pre-quit

Drug - Preparation and Extended Duration Varenicline

27 weeks of varenicline starting 4 weeks pre-quit

Drug - Standard Duration Varenicline

12 weeks of varenicline

Drug - Extended Duration Varenicline

24 weeks of varenicline

Drug - Preparation and Standard Duration Combination NRT

16 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit

Drug - Preparation and Extended Duration Combination NRT

28 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit

Drug - Standard Duration Combination NRT

12 weeks of nicotine patch + nicotine mini-lozenge

Drug - Extended Duration Combination NRT

24 weeks of nicotine patch + nicotine mini-lozenge

Behavioral - Intensive Counseling

3 in-person counseling sessions

Behavioral - Minimal Counseling

2 brief counseling sessions (one phone, one in-person)

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participant.views.study.view.scientific-title

Optimized Chronic Care for Smokers: Developing and Implementing Integrated Clinical and Systems Interventions in Primary Care - Cessation Trial

common.study.values.clinical-trial-id

NCT04188873

participant.views.study.view.id

bkRpxa