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Cessation Screening Project
NCT04188873 · View on ClinicalTrials.gov ↗
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).
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)
Wisconsin
- University of Wisconsin Center for Tobacco Research and Intervention — Madison
- UW Center for Tobacco Research and Intervention — Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 529 participants |
| Start Date | 2020-12-10 |
| Est. Completion | 2025-05-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04188873
The ClinicalTrials.gov registry entry for NCT04188873 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 529 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 943 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Nicotine Dependence appearing as the primary indexed condition, and to 5 interventions — of which Preparation Varenicline and Standard Duration Varenicline is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04188873 reports 2 study locations spanning 1 distinct geographic area — top geographies include Wisconsin. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04188873 about?
NCT04188873 is a clinical study titled "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 primar...
What is the current status of trial NCT04188873?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 529 participants. The study started on 2020-12-10. Estimated completion is 2025-05-08.
What conditions does trial NCT04188873 study?
This clinical trial studies the following conditions: Nicotine Dependence. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04188873?
The interventions under investigation include: 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 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04188873?
This trial is sponsored by University of Wisconsin, Madison, which has 943 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04188873 being conducted?
This trial has 2 study locations across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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