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NCT02148445 · ClinicalTrials.gov registry record · Phase 3
Smoking Cessation Versus Long-term Nicotine Replacement Among High-risk Smokers
A Phase 3 study, sponsored by University of Kansas Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 398
- Enrollment target
NCT02148445 is a Phase 3 study that has completed, run by University of Kansas Medical Center. The registered enrollment target is 398 participants.
The verdict
NCT02148445, a Phase 3 study, has completed, sponsored by University of Kansas Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 398 participants
- Enrollment target
Study Summary
Long-term NRT has not been studied in patients with COPD, and smokers in the United States with COPD are still asked to choose between immediate quitting or continued smoking. The purpose of this study is to see if guided maintenance therapy (GMT), using long-term NRT, might prove to be a reasonable alternative to the standard approach of asking patients to quit immediately. The investigators believe that GMT with long-term NRT will reduce overall exposure to cigarette smoke, reduce harm related to smoking, and ultimately lead to greater quit rates. In this study, 398 smokers with COPD will be randomly assigned to either receive: 1) traditional smoking cessation (SC) or 2) long-term, guided maintenance therapy with NRT (GMT). The SC intervention will be based on a standard approach to smoking cessation, including smoking cessation counseling supplemented with combination NRT (a nicotine patch plus the patient's choice of gum or lozenge) if they are willing to make a quit attempt. The GMT intervention will consist of counseling, focused on medication adherence and smoking reduction, plus 52 weeks of combination NRT. After 3, 6 and 12 months of treatment, we will compare the two treatments based on their effects on smoking cessation, number of cigarettes smoked, exposure to carbon monoxide and smoking-related carcinogens, COPD symptoms, breathing function, and smoking-related hospitalizations or death. The investigators will also analyze the data in such a way that will be able to identify which patients are most likely to benefit from treatment. This analysis will allow patients to estimate their chances of success based on their own personal characteristics and which treatment they choose. The investigators study addresses research priorities identified in recent smoking cessation guidelines and builds upon the input of our Patient Advisory Panel and our Stakeholder Advisory Committee. This study reflects the interests expressed by smokers in prior surveys and add
Interventions
- DRUG Nicotine replacement therapy
- OTHER Standard Smoking Cessation
- OTHER Extended Nicotine Replacement Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 398 participants |
| Start Date | 2014-05 |
| Est. Completion | 2016-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02148445
The ClinicalTrials.gov registry entry for NCT02148445 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 398 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Kansas Medical Center, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Nicotine replacement therapy is the first listed.
NCT02148445 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02148445 about?
NCT02148445 is a clinical study titled "Smoking Cessation Versus Long-term Nicotine Replacement Among High-risk Smokers". Long-term NRT has not been studied in patients with COPD, and smokers in the United States with COPD are still asked to choose between immediate quitting or continued smoking. The purpose of this study is to see if guided maintenance therapy (GMT), using long-term NRT, might prove to be a reasonable...
What is the current status of trial NCT02148445?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 398 participants. The study started on 2014-05. Estimated completion is 2016-12.
What interventions are being tested in trial NCT02148445?
The interventions under investigation include: Nicotine replacement therapy (DRUG), Standard Smoking Cessation (OTHER), Extended Nicotine Replacement Therapy (OTHER).
Who is sponsoring clinical trial NCT02148445?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
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