Switching to e-cigarettes as harm reduction among individuals with chronic disease who currently smoke: Results of a pilot randomized controlled trial.

INTRODUCTION: E-cigarettes (ECs) may be an effective harm reduction strategy for individuals with conditions like chronic obstructive pulmonary disease (COPD), asthma, coronary artery disease (CAD), and peripheral arterial disease (PAD) who smoke combustible cigarettes (CCs). Our aim was to examine how individuals with chronic conditions transition from CCs to ECs and its impact on health outcomes. METHODS: In a pilot randomized controlled trial (RCT), patients with COPD, asthma, CAD/PAD who currently smoke CCs and have not used nicotine replacement therapy (NRT) or ECs in the past 14 days were randomized to receive ECs or combination NRT with behavioral counselling. Disease symptoms, acceptability/satisfaction (TSQM-9) and feasibility, and cigarettes per day (CPD), and/or EC use were collected at baseline, 3-, and 6-months. Descriptive statistics and a linear regression were conducted to explore changes in CPD and chronic condition-specific assessments (CAT, SAQ-7, ACT) that assess COPD, asthma, and CAD/PAD symptom change. RESULTS: At 3-months, the EC group (n=63, mean CPD=9±11) reduced their CPD by 54% vs. 60% in the NRT group (n=58, mean CPD=7±6), p=0.56. At 6-months, 17.5% had switched completely to ECs while 23% quit smoking in the NRT arm. CAT scores showed a significant 6-point reduction in the EC arm (p=0.03). Participants scored an average of 69±27 for EC effectiveness, 87±23 for convenience, and 75±27 for overall satisfaction. CONCLUSIONS: This pilot study suggests that ECs may be a safer alternative for chronic condition patients using CCs and warrants further research on expected smoking cessation/reduction among individuals who use ECs. IMPLICATIONS: The findings from this pilot RCT hold significant implications with chronic conditions such as COPD, asthma, CAD and PAD who smoke CCs. The observed reduction in cigarettes per day and improvement in respiratory symptoms suggest that switching to ECs appears feasible and acceptable among those with chronic diseases. These results suggest that ECs may offer an alternative for individuals struggling to quit CC smoking through existing pharmacotherapies. This study supports further exploration of switching to ECs as a harm reduction strategy among CC users who have been unsuccessful at quitting by other means.

Patterns of E-cigarette Use and Subsequent Cigarette Smoking Cessation Over 2 Years (2013/2014-2015/2016) in the Population Assessment of Tobacco and Health Study.

INTRODUCTION: Understanding the population impact of e-cigarettes requires determining their effect on cigarette smoking cessation. METHODS: Using the US Population Assessment of Tobacco and Health cohort, we examined smoking cessation among adult current cigarette smokers at Wave 1 with follow-up data at Waves 2 and 3 (n = 9724). RESULTS: By Wave 3 (2015/2016), 17.3% of smokers had quit smoking. Smokers using e-cigarettes daily or who increased to daily use over the three waves were two to four times more likely to have quit in the short term (<1 year) and long term (1+ years) compared with never e-cigarette users (p < .001). E-cigarette use in the last quit attempt was associated with a higher likelihood of short-term (<1 year) quitting at Wave 3 (adjusted relative risk ratio: 1.33; 95% confidence interval: 1.04, 1.71) compared with smokers who did not use an e-cigarette in their last quit attempt. Noncurrent (no use in any wave) e-cigarette users and users who were unstable in use frequency were 33% and 47% less likely to quit in the short-term, respectively (p < .001). Flavored (vs nonflavored) and using a rechargeable (vs disposable) e-cigarette device was associated with an increased likelihood of both short- and long-term quitting. CONCLUSION: Smoking cessation was more likely among frequent e-cigarette users, users of e-cigarettes in last quit attempt, and users of flavored and rechargeable devices. Less frequent, unstable, past, or never e-cigarette users were less likely to quit smoking. Monitoring the relationship between patterns of e-cigarette and cigarette use is complex but critical for gauging the potential of e-cigarettes as a harm reduction tool. IMPLICATIONS: This study suggests that consistent and frequent e-cigarette use over time is associated with cigarette smoking cessation among adults in the United States. In addition, findings suggest that flavored e-cigarette use and use of rechargeable e-cigarette devices can facilitate smoking cessation. These results underscore the importance of carefully defining and characterizing e-cigarette exposure patterns, potential confounders, and use of e-cigarettes to quit smoking, as well as variations in length of the smoking cessation.

Trial Participants' Perceptions of the Impact of Ecological Momentary Assessment on Smoking Behaviors: Qualitative Analysis.

Background: Ecological momentary assessment (EMA) is an increasingly used tool for data collection in behavioral research, including smoking cessation studies. As previous addiction research suggests, EMA has the potential to elicit cue reactivity by triggering craving and increasing behavioral awareness. However, there has been limited evaluation of its potential influence on behavior. Objective: By examining the perspectives of research participants enrolled in a tobacco treatment intervention trial, this qualitative analysis aims to understand the potential impact that EMA use may have had on smoking behaviors that may not have otherwise been captured through other study measures. Methods: We performed a qualitative analysis of in-depth interviews with participants enrolled in a pilot randomized controlled trial of a tobacco treatment intervention that used SMS text messaging to collect EMA data on smoking behaviors. In the pilot randomized controlled trial, combustible cigarette and e-cigarette use and smoking-related cravings were measured as part of an EMA protocol, in which SMS text messaging served as a smoking diary. SMS text messaging was intended for data collection only and not designed to serve as part of the intervention. After a baseline assessment, participants were asked to record daily nicotine use for 12 weeks by responding to text message prompts that they received 4 times per day. Participants were prompted to share their experiences with the EMA text messaging component of the trial but were not directly asked about the influence of EMA on their behaviors. Transcripts were coded according to the principles of the framework for applied research. The codes were then examined, summarized, and grouped into themes based on the principles of grounded theory. Results: Interviews were analyzed for 26 participants. The themes developed from the analysis suggested the potential for EMA, in the form of an SMS text messaging smoking diary, to influence participants' smoking behaviors. The perceived impacts of EMA text messaging on smoking behaviors were polarized; some participants emphasized the positive impacts of text messages on their efforts to reduce smoking, while others stressed the ways that text messaging negatively impacted their smoking reduction efforts. These contrasting experiences were captured by themes reflecting the positive impacts on smoking behaviors, including increased awareness of smoking behaviors and a sense of accountability, and the negative impacts on emotions and smoking behaviors, including provoking a sense of guilt and triggering smoking behaviors. Conclusions: The collection of EMA smoking behavior data via SMS text messaging may influence the behaviors and perceptions of participants in tobacco treatment interventions. More research is needed to determine the magnitude of impact and mechanisms, to account for the potential effects of EMA. A broader discussion of the unintended effects introduced by EMA use is warranted among the research community.

Integrating the "Quit and Stay Quit Monday" Model into Smoking Cessation Services for Smokers with Mental Health Conditions: A Pilot Randomized Controlled Trial.

Introduction: People with mental health conditions (MHCs) are less likely to achieve long-term abstinence than people without MHCs. The Quit and Stay Quit Monday (QSQM) model offers a long-term approach to treating tobacco use by encouraging people to quit, requit, or recommit to quit smoking every Monday. Aim: To evaluate the efficacy, patient satisfaction, and patient engagement with an intervention that integrated the QSQM model into multicomponent smoking cessation services among people with an MHC. Methods: This was a randomized controlled pilot trial. Eligibility criteria were as follows: (1) ≥18 years old, (2) smoked a cigarette in the past 30 days, (3) diagnosis of an ICD-10 MHC, (4) interest in quitting smoking, (5) able to receive services in English, and (5) had an active email and a cell phone. The intervention group (n = 33) received QSQM-focused telephone coaching, a weekly QSQM email newsletter, a SmokefreeTXT anchored around a Monday quit date, and 4 weeks of nicotine replacement therapy (NRT). The control group (n = 36) received information about contacting their state Quitline for usual services. Primary outcomes were self-reported quit attempts, 7-day abstinence, and intervention satisfaction at 3 months. Results: Twenty-four participants (73%) in the intervention group began telephone coaching, 26 (79%) enrolled in the QSQM email newsletter, 19 (58%) enrolled in SmokefreeTXT, and 15 (46%) used NRT. Using a penalized intent-to-treat approach, quit attempts in the intervention and control groups were 63.6% and 38.9% (OR 2.75, 95% CI 1.03-7.30), respectively. Seven-day abstinence in the two groups was 12.1% and 5.6% (OR 2.35, 95% CI 0.40-13.74), respectively. Of the 15 intervention group participants who set a quit date during the intervention, 13 (86.7%) selected a Monday quit day. Qualitative interviews revealed positive participant experiences with picking a Monday quit day. On follow-up surveys, 89.5%, 69.3%, and 64.3% of intervention participants reported that the counseling, QSQM email, and text messaging, respectively, were very or somewhat helpful. Conclusions: The QSQM model was acceptable and potentially efficacious among people with MHCs, but intervention engagement and satisfaction were modest. Future research should adapt or develop new QSQM delivery approaches to improve patient engagement and potential efficacy of the model. This trial is registered with clinicaltrials.gov (NCT04512248).

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

BACKGROUND: 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. 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. METHODS: In 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. DISCUSSION: Despite 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.