Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02354872 · ClinicalTrials.gov registry record · Phase 4
Motivation Project: Testing Intervention Components for the Smoker Who is Unwilling to Quit
A Phase 4 study, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 4
- Development phase
- 577
- Enrollment target
NCT02354872: Completed Phase 4 study, sponsored by University of Wisconsin, Madison.
NCT02354872 is a Phase 4 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 577 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (11% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02354872, a Phase 4 study, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 577 participants
- Enrollment target
Study Summary
The ultimate goal of this research is to develop a chronic care treatment package for smokers that will address the challenges and opportunities of each phase of the cessation process - motivation, preparation, cessation, maintenance, and relapse recovery. That is, to develop treatments for smokers not yet ready to quit, those who are preparing to quit, those actively engaged in the quitting process and those who have tried to quit but relapsed. To achieve this goal, this research comprises three distinct research studies, each of which represent a phase in a comprehensive chronic care treatment model for clinical intervention with smokers in the primary care setting: the Motivation Study, the Cessation Study, and the Long-term Quitting Study. The goal of each study is to test and identify effective intervention components for distinct phases of the smoking cessation process. These components will then be combined for future research on the effectiveness of this chronic care treatment package. This study is a 2x2x2x2 factorial design. Participants will be randomized to one of two levels on four different factors: 1) Nicotine Mini-Lozenge vs. No Mini-Lozenge, 2) Behavioral Reduction Counseling (intervention: BR) vs. No Behavioral Reduction Counseling, 3) 5Rs Motivation Counseling (intervention 5 R's) vs. No 5Rs Motivation Counseling, and 4) Behavioral Activation Counseling (intervention BA) vs. No Behavioral Activation Counseling. These components have strong theoretical and empirical support, but their relative, additive, and interactive effects are unknown.
Primary Outcome
Participants who self-report no smoking for the past 7 days at the assessment endpoint (12 month follow-up) will be considered to meet criteria for 7-Day Point-Prevalence Abstinence. Participants who who report any smoking in the past 7 days (at the 12 month follow-up) will be considered to be relapsed (smoking).
Interventions
- OTHER No Treatment
- BEHAVIORAL Behavioral Activation Counseling
- DRUG Nicotine Mini-Lozenge
- BEHAVIORAL Behavioral Reduction Counseling
- BEHAVIORAL 5Rs Motivation Counseling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 577 participants |
| Start Date | 2015-01 |
| Est. Completion | 2019-03-19 |
| Phase | Phase 4 |
What the finished NCT02354872 record still lists
NCT02354872 is an interventional study that assigns participants to a tested intervention. The registered 577 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (11% higher).
The record links to 0 conditions, and to 5 interventions - of which No Treatment is the first listed.
NCT02354872 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02354872 about?
NCT02354872 is a clinical study titled "Motivation Project: Testing Intervention Components for the Smoker Who is Unwilling to Quit". The ultimate goal of this research is to develop a chronic care treatment package for smokers that will address the challenges and opportunities of each phase of the cessation process - motivation, preparation, cessation, maintenance, and relapse recovery. That is, to develop treatments for smokers ...
What is the current status of trial NCT02354872?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 577 participants. The study started on 2015-01. Estimated completion is 2019-03-19.
What interventions are being tested in trial NCT02354872?
The interventions under investigation include: No Treatment (OTHER), Behavioral Activation Counseling (BEHAVIORAL), Nicotine Mini-Lozenge (DRUG), Behavioral Reduction Counseling (BEHAVIORAL), 5Rs Motivation Counseling (BEHAVIORAL).
Who is sponsoring clinical trial NCT02354872?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02354872's enrollment target sits among peer trials
577 149th of 2000 higher than 1,851 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT07290543 · 578 participants · NA
Web-Based Toolkit to Improve Cancer-Related Emotional Distress and Anxiety in Rural Older Cancer Survivors
- NCT04931810 · 576 participants · NA
Urban and Reservation Implementation of All Nations Breath of Life
- NCT05179369 · 576 participants · NA
Well-Mama Community Doula Navigator Study
- NCT06398509 · 576 participants · NA
A Primary Care Based Intervention to Prevent Childhood Obesity Among Low-income Latino Children
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia