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

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

Conditions

• Smoking
• Pulmonary Disease, Chronic Obstructive
• Tobacco Use Disorder

Interventions

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.

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

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• University of Kansas Medical Center

  lead OTHER

Principal Investigators

• Edward F Ellerbeck, MD · University of Kansas

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-05-31

Primary Completion

2016-12-31

Completion

2016-12-31

Countries

• United States

Study Locations