Clinical trial NCT02148445: Smoking Cessation Versus Long-term Nicotine Replacement Among High-risk Smokers
Official title: Smoking Cessation Versus Long-term Nicotine Replacement Among High-risk Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking
Pulmonary Disease, Chronic Obstructive
Tobacco Use Disorder
Keywords: smoking cessation
tobacco use cessation products
nicotine
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-05-28
Enrollment: 398
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: Smoking Abstinence (Point Prevalent)
timeFrame: Month 12
Secondary outcomes:
measure: Sustained Abstinence
timeFrame: Month 6 through Month 12
measure: Quit Attempts
timeFrame: Month 3, Month 6, Month 12
measure: Average Cigarettes Per Day
timeFrame: Month 3, Month 6, Month 12
measure: Carbon Monoxide Exposure
timeFrame: Month 3, Month 6, Month 12
measure: Carcinogen Exposure
timeFrame: Month 3, Month 6, Month 12
measure: Respiratory Function
timeFrame: Month 12
measure: Respiratory Symptoms
timeFrame: Month 3, Month 6, Month 12
measure: Respiratory-related Hospital Visits
timeFrame: Month 3, Month 6, Month 12
measure: Cardiac-related Hospital Visits
timeFrame: Month 3, Month 6, Month 12
measure: 7-day Abstinence
timeFrame: Month 3, Month 6, Month 12
measure: Cotinine
timeFrame: Month 3, Month 6, Month 12
measure: Average Cigarettes Per Day (Continued Smokers Only)
timeFrame: Month 3, Month 6, Month 12
measure: Carbon Monoxide Exposure (Continued Smokers Only)
timeFrame: Month 3, Month 6, Month 12
measure: Carcinogen Exposure (Continued Smokers Only)
timeFrame: Month 3, Month 6, Month 12
measure: Cotinine (Continued Smokers Only)
timeFrame: Month 3, Month 6, Month 12
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas
name: Edward F Ellerbeck, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ellerbeck EF, Nollen N, Hutcheson TD, Phadnis M, Fitzgerald SA, Vacek J, Sharpe MR, Salzman GA, Richter KP. Effect of Long-term Nicotine Replacement Therapy vs Standard Smoking Cessation for Smokers With Chronic Lung Disease: A Randomized Clinical Trial. JAMA Netw Open. 2018 Sep 7;1(5):e181843. doi: 10.1001/jamanetworkopen.2018.1843.