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Smoking cessation versus long-term nicotine replacement among high-risk smokers
Investigator (PI): Ellerbeck, Edward
Performing Organization (PO): (Current): University of Kansas Medical Center, School of Medicine, Department of Preventive Medicine and Public Health / (913) 588-2775
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2014
Final Year: 2018
Record Source/Award ID: PCORI/CER-1306-02901
Funding: Total Award Amount: $2,134,842
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Smokers with chronic obstructive pulmonary disease (COPD), realize that smoking is dangerous and would like to quit, but at any given time, most of them are intimidated by the idea of going cold turkey. Many of these smokers would like to cut back on the amount that they smoke as part of a longer term plan for quitting. Long-term nicotine replacement therapy (NRT) might allow them to do just that. Long-term NRT is safe; it can reduce the pleasure of continued smoking leading to reduced amounts of cigarettes smoked and higher quit rates. Long-term NRT has not, however, been studied in patients with COPD, and smokers in the United States with COPD are still asked to choose between immediate quitting and 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. We 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. We will also analyze the data in such a way that we 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. Our 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 interests expressed by smokers in prior surveys and addresses the limited reach and effectiveness of traditional approaches to smoking cessation. If our GMT approach is effective, our study could change the recommendations provided in clinical practice guidelines and change the way that insurance companies pay for smoking cessation treatment. GMT could provide an alternative for millions of smokers with COPD who are not currently benefiting from traditional approaches to smoking cessation.
MeSH Terms:
  • Administration, Cutaneous
  • Carbon Monoxide /chemistry
  • Chewing Gum
  • Hospitalization
  • Humans
  • Medication Adherence
  • Nicotine /administration & dosage
  • /*therapeutic use
  • Pulmonary Disease, Chronic Obstructive /therapy
  • Randomized Controlled Trials as Topic
  • Risk
  • Smoking
  • * Smoking Cessation
  • Time Factors
  • Tobacco Use Disorder /*therapy
  • United States
Country: United States
State: Kansas
Zip Code: 66160
UI: 20143546
CTgovId: NCT02148445
Project Status: Completed
Record History: ('2017: Project extended to 2018.',)