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NCT04188873 · ClinicalTrials.gov registry record · Phase 4
Cessation Screening Project
A Phase 4 study of Nicotine Dependence, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 4
- Development phase
- 529
- Enrollment target
- 2
- Study locations
NCT04188873 is a Phase 4 study of Nicotine Dependence that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 529 participants, above the 179-participant average among 67 other Nicotine Dependence trials with a reported enrollment target (196% higher). The trial reports 2 study locations across 1 state.
The verdict
NCT04188873, a Phase 4 study of Nicotine Dependence, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 529 participants
- Enrollment target
- 2
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 4. The registered enrollment target is 529 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 179-participant average among 67 other Nicotine Dependence trials with a reported enrollment target (196% higher). The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
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.
NCT04188873 reports 2 study locations spanning 1 distinct geographic area - top geographies include Wisconsin.
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.
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).
Who is sponsoring clinical trial NCT04188873?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
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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Related
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