Cessation Screening Project
common.study.values.description
“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
participant.ui.study.affiliations-map.online-study.header-virtual
participant.ui.study.affiliations-map.online-study.text
common.study.values.methods
common.study.methods.has-drugs-yes
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)
participant.views.study.view.additional
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
