Electronic cigarettes as a harm reduction strategy among patients with COPD: protocol for an open-label two arm randomized controlled pilot trial

Elizabeth R Stevens,Lei Lei,Omar El-Shahawy,Thomas R Kirchner,Kenneth I Berger,Charles M Cleland,Mahathi Vojjala,Scott E Sherman

doi:10.1186/s13722-021-00284-0

Abstract

BackgroundSmoking cessation is the most effective means of slowing the decline of lung function associated with chronic obstructive pulmonary disease (COPD). While effective smoking cessation treatments are available, they are underutilized and nearly half of people with COPD continue to smoke. By addressing both nicotine and behavioral dependence, electronic cigarettes (EC) could help people with COPD reduce the harm of combustible cigarettes (CC) through reductions in number of Cigarettes per Day (CPD) or quitting CC completely. The purpose of this pilot study is to identify barriers and facilitators to the use of and assess the preliminary effectiveness of EC as a harm reduction strategy among people with COPD.MethodsIn an open-label two-arm randomized controlled trial pilot study, 60 patients identified as smokers with a COPD diagnosis via electronic health records from a large urban health center are randomized in a 1:1 ratio to either standard care [counseling + nicotine replacement therapy (NRT)] or counseling + EC. The NRT arm will receive nicotine patches and nicotine lozenges for 12 weeks. The EC arm will receive EC for 12 weeks. Both cohorts will receive counseling from a licensed mental health counselor. Using ecological momentary assessment, participants will report their use of CC in both arms and EC use in the EC arm daily via text message. Primary outcomes will be feasibility and acceptability of intervention, and secondary outcomes will be reduction in CPD and change in COPD symptoms as measured by COPD Assessment Tool (CAT) score at 12-weeks. EC displacement of CC. To explore attitudes towards the use of EC as a harm-reduction strategy for patients with COPD, interviews will be performed with a sample of participants from both study arms.DiscussionDespite decades of availability of smoking cessation medications, nearly half of people with COPD still smoke. This study aims to address the unmet need for feasible and effective strategies for reducing CC use among those with COPD, which has the potential to significantly improve the health of people with COPD who smoke.Trial Registration ClinicalTrials.gov Identifier: NCT04465318.

Highlights

Despite considerable progress, smoking remains the leading preventable cause of death in the United States (US), causing 480,000 deaths and $300 billion in healthrelated economic losses each year [1]
Secondary hypotheses include: (1) An electronic cigarettes (EC) harm-reduction intervention will be more effective than nicotine replacement therapy (NRT) in reducing Cigarettes per Day (CPD) in patients with chronic obstructive pulmonary disease (COPD) who smoke; and (2) An EC harm-reduction intervention will be more effective than NRT in reducing COPD symptoms in patients with COPD who smoke
For secondary analyses of effectiveness, in a Poisson generalized linear model for the number of combustible cigarettes (CC) reduced from baseline to follow-up, we will have greater than 90% power to detect a rate ratio of RR = 1.60

Summary

Introduction

Despite considerable progress, smoking remains the leading preventable cause of death in the United States (US), causing 480,000 deaths and $300 billion in healthrelated economic losses each year [1]. The burden of COPD is even greater, with COPD projected to be the third largest cause of death by 2030 [4] Among those with COPD who smoke, smoking cessation is the most effective means of slowing the decline of lung function and overall disease progression [5, 6]. Smoking cessation is the most effective means of slowing the decline of lung function associated with chronic obstructive pulmonary disease (COPD). While effective smoking cessation treatments are available, they are underutilized and nearly half of people with COPD continue to smoke By addressing both nicotine and behavioral dependence, electronic cigarettes (EC) could help people with COPD reduce the harm of combustible cigarettes (CC) through reductions in number of Cigarettes per Day (CPD) or quitting CC completely.

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