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Smoking Cessation Versus Long-term Nicotine Replacement Among High-risk Smokers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02148445
Recruitment Status : Completed
First Posted : May 28, 2014
Results First Posted : July 2, 2017
Last Update Posted : October 6, 2017
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Edward Ellerbeck, MD, MPH, University of Kansas Medical Center

Brief 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 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


Condition or disease Intervention/treatment Phase
Smoking Pulmonary Disease, Chronic Obstructive Tobacco Use Disorder Other: Standard Smoking Cessation Other: Extended Nicotine Replacement Therapy Drug: Nicotine replacement therapy Phase 3

Detailed Description:

BACKGROUND Smokers with chronic obstructive pulmonary disease (COPD) recognize the dangers of continued smoking and would like to quit, but for most of them the idea of going 'cold turkey' is too intimidating. Many of these smokers would like to cut back on the amount that they smoke as part of a longer term path to quitting. Long-term nicotine replacement therapy (NRT) might allow them to do this. Long-term NRT is safe; it can reduce the rewarding effects of cigarettes, reduce the amount that people smoke, and increase 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 or continued smoking. The purpose of this study is to evaluate the relative benefits of a third option: guided maintenance therapy with long-term NRT. We believe that long-term NRT could reduce overall exposure to cigarette smoke, reduce harm related to smoking, and ultimately lead to greater quit rates.

OBJECTIVES

  1. Compare the benefits of traditional smoking cessation (SC) versus guided maintenance therapy (GMT) with NRT for smokers with COPD.
  2. Estimate rates of smoking cessation and other patient-desired outcomes based on patient-specific characteristics and treatment choice (SC or GMT).

METHODS In this study, we will randomize 398 smokers with COPD to one of two treatment arms: 1) traditional smoking cessation (SC) or 2) long-term, guided maintenance therapy with NRT (GMT). Participants in the SC arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with combination NRT (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt. Participants in the GMT arm will receive counseling focused on medication adherence and smoking reduction plus 52 weeks of combined NRT. Outcomes will be measured at 3, 6 and 12 months post-randomization and will assess rates of smoking cessation, number of cigarettes smoked, exposure to carbon monoxide and smoking-related carcinogens, and clinical outcomes including respiratory symptoms, respiratory function, and smoking-related hospitalizations or death. In addition to directly comparing outcomes in the two treatment arms, our novel classification and regression tree analysis will allow us to identify subgroups of patients most likely to benefit from treatment and will allow patients to estimate their projected outcomes given their personal history and their choice of therapy.

PATIENT OUTCOMES (PROJECTED) This study will show how long-term NRT compares to a traditional smoking cessation program in helping smokers quit, reduce cigarette exposure, lower exposure to carcinogens, and reduce risk for death and hospitalizations. If our hypothesis is correct, this program could dramatically alter treatment choices for the millions of smokers in the United States with COPD that have been frustrated in their attempts to quit.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 398 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Smoking Cessation Versus Long-term Nicotine Replacement Among High-risk Smokers
Study Start Date : May 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard Smoking Cessation
Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
Other: Standard Smoking Cessation
Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.

Drug: Nicotine replacement therapy
Other Name: nicotine patch, nicotine gum, nicotine lozenge

Experimental: Extended Nicotine Replacement Therapy
Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
Other: Extended Nicotine Replacement Therapy
Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.

Drug: Nicotine replacement therapy
Other Name: nicotine patch, nicotine gum, nicotine lozenge




Primary Outcome Measures :
  1. Smoking Abstinence (Point Prevalent) [ Time Frame: Month 12 ]
    7-day point prevalent abstinence at 12 months, confirmed by exhaled CO <=10


Secondary Outcome Measures :
  1. Sustained Abstinence [ Time Frame: Month 6 through Month 12 ]
    6 month sustained abstinence as measured by self-report at 6 and 12 months and confirmed by CO at 6 and 12 months. Participants who were confirmed as non-smokers by carbon monoxide (CO) at both Month 6 and Month 12 were considered to have "6-month sustained abstinence."

  2. Quit Attempts [ Time Frame: Month 3, Month 6, Month 12 ]
    Number of self-reported quit attempts over one year. At Month 3 and Month 6, participants reported the number of quit attempts in the last 3 months. At Month 12, participants reported the number of quit attempts in the last 6 months.

  3. Average Cigarettes Per Day [ Time Frame: Month 3, Month 6, Month 12 ]
    Average number of cigarettes per day over one year. Participants were asked at Month 3, Month 6, and Month 12 "During the past 7 days, on those days that you smoked, what was the average number of cigarettes or little cigars smoked per day?"

  4. Carbon Monoxide Exposure [ Time Frame: Month 3, Month 6, Month 12 ]
    Carbon monoxide (CO) exposure over 12 months. At Month 3, Month 6, and Month 12, participants completed an expired carbon monoxide laboratory test, which measured CO in parts per million.

  5. Carcinogen Exposure [ Time Frame: Month 3, Month 6, Month 12 ]
    Creatinine-adjusted NNAL (4-(methylnitrosamino)-1-(3)pyridyl-1-butanol)) exposure over 12 months. At Month 3, Month 6, and Month 12, participants provided a urine sample that was used to assess their level of urinary creatinine and NNAL.

  6. Respiratory Function [ Time Frame: Month 12 ]
    Change in respiratory function, as measured by spirometry (FEV1), at 12 months post-randomization.

  7. Respiratory Symptoms [ Time Frame: Month 3, Month 6, Month 12 ]
    Respiratory symptoms as measured by the COPD Assessment Test (CAT) respiratory questionnaire. Participants completed this 8-item assessment at Month 3, Month 6, and Month 12. Scores range from 0 to 40, with higher levels indicating higher impact of COPD on well-being and daily life.

  8. Respiratory-related Hospital Visits [ Time Frame: Month 3, Month 6, Month 12 ]
    Number of respiratory-related hospital admissions and emergency room visits. Participants were asked how many times they had visited the ED or were admitted to the hospital for respiratory-related problems at Month 3, Month 6, and Month 12

  9. Cardiac-related Hospital Visits [ Time Frame: Month 3, Month 6, Month 12 ]
    Number of cardiac-related hospital admissions and emergency room visits. Participants were asked how many times they had visited the ED or were admitted to the hospital for cardiac-related problems at Month 3, Month 6, and Month 12.

  10. 7-day Abstinence [ Time Frame: Month 3, Month 6, Month 12 ]
    Self-reported and biochemically verified 7-day abstinence. Participants were asked at Month 3, Month 6, and Month 12, "Have you smoked any cigarettes or little cigars, even a puff, in the past 7 days?" They also completed an exhaled carbon monoxide lab test at Month 3, 6 and 12. Biochemical verification= exhaled CO <=10 ppm. Month 12 biochemically verified abstinence is the primary outcome, and is not reported in this table.

  11. Cotinine [ Time Frame: Month 3, Month 6, Month 12 ]
    Cotinine over 12 months, adjusted for creatinine. At Month 3, Month 6, and Month 12, participants provided a urine sample that was used to assess their level of urinary creatinine and cotinine.

  12. Average Cigarettes Per Day (Continued Smokers Only) [ Time Frame: Month 3, Month 6, Month 12 ]
    Average number of cigarettes per day over one year, among continued smokers. All participants were asked "During the past 7 days, on those days that you smoked, what was the average number of cigarettes smoked per day?" at Month 3, Month 6, and Month 12. This analysis looks at the number of cigarettes per day among participants who were still smoking.

  13. Carbon Monoxide Exposure (Continued Smokers Only) [ Time Frame: Month 3, Month 6, Month 12 ]
    Carbon monoxide (CO) exposure over 12 months. At Month 3, Month 6, and Month 12, participants completed an expired carbon monoxide laboratory test, which measured CO in parts per million. This analysis looks at CO among those continuing to smoke.

  14. Carcinogen Exposure (Continued Smokers Only) [ Time Frame: Month 3, Month 6, Month 12 ]
    Creatinine-adjusted NNAL (4-(methylnitrosamino)-1-(3)pyridyl-1-butanol)) exposure over 12 months. At Month 3, Month 6, and Month 12, participants provided a urine sample that was used to assess their level of urinary creatinine and NNAL. This analysis looks at NNAL among continuing smokers only.

  15. Cotinine (Continued Smokers Only) [ Time Frame: Month 3, Month 6, Month 12 ]
    Cotinine over 12 months, adjusted for creatinine. At Month 3, Month 6, and Month 12, participants provided a urine sample that was used to assess their level of urinary creatinine and cotinine. This analysis looks at NNAL among continuing smokers only.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Physician-diagnosed COPD
  • Smoke 5 or more cigarettes/day
  • Smoke cigarettes on 25 or more of the last 30 days
  • Speak either English or Spanish
  • Willing to take nicotine replacement therapy for up to 1 year and participate in study procedures

Exclusion Criteria:

  • Reside in a facility that does not allow smoking
  • Don't have an address and telephone
  • Unstable cardiac condition (e.g. unstable angina or myocardial infarction in the past 30 days)
  • Pregnant or breastfeeding
  • Terminal illness with less than 12 month life expectancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02148445


Locations
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United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Edward F Ellerbeck, MD University of Kansas

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Edward Ellerbeck, MD, MPH, Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02148445    
Other Study ID Numbers: STUDY00000666
CER-1306-02901 ( Other Identifier: PCORI )
First Posted: May 28, 2014    Key Record Dates
Results First Posted: July 2, 2017
Last Update Posted: October 6, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will create a clean, de-identified copy of our dataset. It will be available to other researchers, upon request. We will make data available to users under a data sharing agreement that provides for (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Data will be saved as SAS or SPSS files, saved to disk, encrypted, and mailed to users. A copy of our analytic code used to generate our primary outcomes paper(s) will also be available on request. Given that this study does not meet the threshold for data sharing requirements, the costs of data preparation and shipping will be borne by the requester.
Keywords provided by Edward Ellerbeck, MD, MPH, University of Kansas Medical Center:
smoking cessation
tobacco use cessation products
nicotine
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Tobacco Use Disorder
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action