Cessation Screening Project

Study Summary

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 (Intensive vs. Minimal). Participants will complete assessments one week pre-quit and then assessments of smoking status, treatment use, side effects, potential treatment mechanisms (e.g., withdrawal, self-efficacy) during the first week post-target quit date (TQD) and at Weeks 2, 4, 12, 20, 26, and 52 post-target quit date. 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).

Primary Outcome

Participants will be asked to report on any smoking in the last seven days at a follow-up phone interview scheduled to occur 12-months post-target quit day (post-TQD). Those claiming complete abstinence (not even a puff from a cigarette) in the last seven days at this follow-up interview will be asked to provide a saliva sample for biochemical verification of self-reported abstinence via cotinine testing. Participants who report abstinence in the last 7 days at this visit but have a cotinine lev

Conditions Studied

Interventions

• DRUG Preparation Varenicline and Standard Duration Varenicline
• DRUG Preparation Varenicline and Extended Duration Varenicline
• DRUG Standard Duration Varenicline
• DRUG Extended Duration Varenicline
• DRUG Preparation Combination NRT and Standard Duration Combination NRT

Study Locations (2)