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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 is a Phase 4 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 577 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02354872
The ClinicalTrials.gov registry entry for NCT02354872 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 577 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 1,039 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which No Treatment is the first listed.
NCT02354872 reports 0 study locations.
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.
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