CompletedPhase 4

Cessation Screening Project

United States538 participantsStarted 2020-12-10

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Smoking \>4 cigarettes/day for the previous 6 months * Able to read, write, and speak English * If currently using nicotine replacement therapy (NRT), agreeing to use only study medication for the duration of the study * Medically eligible to use study medications * If the participant is a woman of childbearing potential, using an approved method of birth control during treatment Exclusion Criteria: * Currently taking bupropion or varenicline * Suicidal ideation in the last 12 months or any suicide attempts in the past 10 years

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial used biochemically verified abstinence as its main measure, meaning participants had to prove they had stopped smoking through a lab test — can you explain what that verification process involved and whether that level of accountability would actually help me stay on track?
2Since this was a Phase 4 trial, the treatment being tested was already approved — does that mean there's a well-established safety profile I can review, and how does what was studied here compare to what you might already prescribe me for quitting nicotine?
3The trial is now completed, so results should be available — have you seen any published findings from this study, and do the quit rates they measured look meaningful compared to other cessation approaches?
4This study focused on a screening-based approach to cessation — does that mean it was testing how to better identify and connect people to quit support, and would a similar screening process be part of my care with you?
5Given that this trial is finished and I wasn't part of it, are there any currently open cessation trials or standard treatment pathways you'd recommend that reflect what was learned from studies like this one?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Intent-to-treat Biochemically Verified 7-day Point Prevalence Abstinence

Timeframe: 12 months post-target quit day (TQD)

Trial details

NCT IDNCT04188873

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-08

Results submitted2026-04-23

View on ClinicalTrials.gov More Nicotine Dependence trials