Cessation Screening Project

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).

Conditions

• Nicotine Dependence

Interventions

DRUG

Preparation Varenicline and Standard Duration Varenicline

16 weeks of varenicline starting 4 weeks pre-quit

DRUG

Preparation Varenicline and Extended Duration Varenicline

28 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 Combination NRT and Standard Duration Combination NRT

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

DRUG

Preparation Combination NRT 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

4 phone or video counseling sessions

BEHAVIORAL

Minimal Counseling

2 brief phone or video counseling sessions

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• University of Wisconsin, Madison

  lead OTHER

Principal Investigators

• Megan E Piper, PhD · University of Wisconsin, Madison

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-12-10

Primary Completion

2025-05-08

Completion

2025-05-08

FDA Drug

Yes

Countries

• United States

Study Locations