Dataset Information

A Randomized Controlled Trial Evaluating the Efficacy of E-Cigarette Use for Smoking Cessation in the General Population: E3 Trial Design.

ABSTRACT:

Background

Smoking cessation improves morbidity and mortality among smokers who achieve long-term abstinence. Many smokers are using electronic cigarettes (e-cigarettes) to attempt to quit, despite a lack of data concerning their efficacy and safety for smoking cessation.

Methods

The Evaluating the Efficacy of E-Cigarette use for Smoking Cessation (E3) trial is a multicentre randomized controlled trial (NCT02417467) with a treatment period of 12 weeks and follow-up of 52 weeks. A total of 376 participants motivated to quit smoking were enrolled at 17 Canadian centres (November 2016 to September 2019). Participants were randomized (1:1:1) to 1 of 3 treatment arms: nicotine e-cigarettes, non-nicotine e-cigarettes, or no e-cigarettes. All groups received individual counselling. Treatment allocation was double-blind for the e-cigarette groups. The trial includes follow-ups by telephone at weeks 1, 2, 8, and 18, and clinic visits at weeks 4, 12, 24, and 52. The primary endpoint is to compare nicotine e-cigarettes to counselling alone in terms of biochemically validated point-prevalence smoking abstinence at 12 weeks; the primary endpoint was changed from 52 weeks after early termination (77% of targeted enrollment) due to a prolonged delay in e-cigarette manufacturing. The secondary objectives are to examine the efficacy of nicotine and non-nicotine e-cigarettes in terms of point-prevalence and continuous smoking abstinence, and reduction in daily cigarette consumption at all follow-ups through week 52, and to describe the occurrence of adverse events.

Conclusion

The E3 trial will provide regulators, health care professionals, and smokers with important information about the efficacy and safety of e-cigarettes for smoking cessation.

SUBMITTER: Hebert-Losier A

PROVIDER: S-EPMC7242503 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A Randomized Controlled Trial Evaluating the Efficacy of E-Cigarette Use for Smoking Cessation in the General Population: E3 Trial Design.

Hébert-Losier Andréa A Filion Kristian B KB Windle Sarah B SB Eisenberg Mark J MJ

CJC open 20200319 3

<h4>Background</h4>Smoking cessation improves morbidity and mortality among smokers who achieve long-term abstinence. Many smokers are using electronic cigarettes (e-cigarettes) to attempt to quit, despite a lack of data concerning their efficacy and safety for smoking cessation.<h4>Methods</h4>The Evaluating the Efficacy of E-Cigarette use for Smoking Cessation (E3) trial is a multicentre randomized controlled trial (NCT02417467) with a treatment period of 12 weeks and follow-up of 52 weeks. A ...[more]

PMID: 32462131

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Project description:BackgroundWhile smoking cessation has been linked to substantial weight gain, the potential influence of e-cigarettes on weight changes among individuals who use these devices to quit smoking is not fully understood.ObjectiveThis study aims to reanalyze data from the Evaluating the Efficacy of e-Cigarette Use for Smoking Cessation (E3) trial to assess the causal effects of e-cigarette use on change in body weight.MethodsThis is a secondary analysis of the E3 trial in which participants were randomized into 3 groups: nicotine e-cigarettes plus counseling, nonnicotine e-cigarettes plus counseling, and counseling alone. With adjustment for baseline variables and the follow-up smoking abstinence status, weight changes were compared between the groups from baseline to 12 weeks' follow-up. Intention-to-treat and as-treated analyses were conducted using doubly robust estimation. Further causal analysis used 2 different propensity scoring methods to estimate causal regression curves for 4 smoking-related continuous variables. We evaluated 5 different subsets of data for each method. Selection bias was addressed, and missing data were imputed by the machine learning method extreme gradient boosting (XGBoost).ResultsA total of 257 individuals with measured weight at week 12 (mean age: 52, SD 12 y; women: n=122, 47.5%) were included. Across the 3 treatment groups, of the 257 participants, 204 (79.4%) who continued to smoke had, on average, largely unchanged weight at 12 weeks, with comparable mean weight gain ranging from -0.24 kg to 0.33 kg, while 53 (20.6%) smoking-abstinent participants gained weight, with a mean weight gain ranging from 2.05 kg to 2.70 kg. After adjustment, our analyses showed that the 2 e-cigarette arms exhibited a mean gain of 0.56 kg versus the counseling alone arm. The causal regression curves analysis also showed no strong evidence supporting a causal relationship between weight gain and the 3 e-cigarette-related variables. e-Cigarettes have small and variable causal effects on weight gain associated with smoking cessation.ConclusionsIn the E3 trial, e-cigarettes seemed to have minimal effects on mitigating the weight gain observed in individuals who smoke and subsequently quit at 3 months. However, given the modest sample size and the potential underuse of e-cigarettes among those randomized to the e-cigarette treatment arms, these results need to be replicated in large, adequately powered trials.Trial registrationClinicalTrials.gov NCT02417467; https://www.clinicaltrials.gov/study/NCT02417467.

Project description:BackgroundMany adults use e-cigarettes to help them quit cigarette smoking. However, the impact of self-selected use of e-cigarettes on cigarette smoking cessation, particularly when concurrently receiving app-based behavioral interventions, remains unexplored.ObjectiveThis study used data from a randomized trial of 2 smartphone apps to compare 12-month cigarette smoking cessation rates between participants who used e-cigarettes on their own (ie, adopters: n=465) versus those who did not (ie, nonadopters: n=1097).MethodsThe study population included all participants who did not use e-cigarettes at baseline. "Adopters" were those who self-reported the use of e-cigarettes at either 3- or 6-month follow-ups. "Nonadopters" were those who self-reported no use of e-cigarettes at either follow-up time point. The primary cessation outcome was self-reported, complete-case, 30-day point prevalence abstinence from cigarette smoking at 12 months. Secondary outcomes were missing-as-smoking and multiple imputation analyses of the primary outcome, prolonged abstinence, and cessation of all nicotine and tobacco products at 12 months. In logistic regression models, we first examined the potential interaction between e-cigarette use and treatment arm (iCanQuit vs QuitGuide) on the primary cessation outcome. Subsequently, we compared 12-month cigarette smoking cessation rates between adopters and nonadopters separately for each app.ResultsThere was suggestive evidence for an interaction between e-cigarette use and treatment arm on cessation (P=.05). In the iCanQuit arm, 12-month cigarette smoking cessation rates were significantly lower among e-cigarette adopters compared with nonadopters (41/193, 21.2% vs 184/527, 34.9%; P=.003; odds ratio 0.55, 95% CI 0.37-0.81). In contrast, in the QuitGuide arm, 12-month cigarette smoking cessation rates did not differ between adopters and nonadopters (46/246, 18.7% vs 104/522, 19.9%; P=.64; odds ratio 0.91, 95% CI 0.62-1.35).ConclusionsThe use of e-cigarettes while concurrently receiving an app-based smoking cessation intervention was associated with either a lower or an unimproved likelihood of quitting cigarette smoking compared to no use. Future behavioral treatments for cigarette smoking cessation should consider including information on the potential consequences of e-cigarette use.Trial registrationClinicalTrials.gov NCT02724462; https://clinicaltrials.gov/study/NCT02724462.

Project description:IntroductionMany cancer patients who smoke report concurrent e-cigarette use. Using a mixed-methods approach, we aimed to (1) describe longitudinal e-cigarette use over 6 months after a cancer diagnosis and (2) assess the association between e-cigarette use and smoking cessation, among cancer patients in a smoking cessation trial.Aims and methodsData were from a 2-site randomized controlled trial of Standard (brief counseling) versus Intensive treatment (sustained counseling plus smoking cessation medication) in individuals who smoke recently diagnosed with cancer. Participants (n = 303) reported e-cigarette use at baseline, 3 months, and 6 months. Biochemically-verified past 7-day cigarette abstinence was collected at 6 months. Qualitative interviews at 6 months explored factors related to e-cigarette use.ResultsE-cigarette use prevalence was highest between baseline and 3 months (16%) and declined over time. Participants using e-cigarettes at follow-up had higher baseline cigarette dependence and smoked more heavily. Multivariable analyses found no significant association between follow-up e-cigarette use and 6-month cigarette abstinence. E-cigarette use at follow-up was higher in the Standard versus Intensive treatment group (p = .003 and .001 at 3 and 6 mo, respectively). Smoking cessation and health concerns were primary reasons for using e-cigarettes.ConclusionsAmong individuals who smoke recently diagnosed with cancer and enrolled in a smoking cessation intervention trial, e-cigarette use during trial participation was not associated with smoking abstinence. Individuals who chose to use e-cigarettes were less likely to be receiving intensive cessation support as part of the trial. Further studies are needed to evaluate the association between e-cigarette use and smoking cessation in cancer patients.ImplicationsE-cigarette use was not associated with cigarette abstinence at 6 months among adults who smoke recently diagnosed with cancer enrolled in a smoking cessation trial. Individuals with easier access to evidence-based smoking cessation treatment may be less likely to use e-cigarettes.

Project description:IntroductionThis study sought to compare medication efficacy in participants with medical comorbidities who smoke in the Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES) trial, a double-blind, triple-dummy, placebo- and active-controlled randomized controlled trial.Aims and methodsParticipants were from the U.S. cohort of the main trial and randomized (1:1:1:1) to varenicline, bupropion, nicotine replacement therapy (NRT) patch, or placebo for 12 weeks with follow-up through week 24. Medical comorbidity data were derived from the baseline medical screening questionnaire and categorized into four subgroups (cardiac, respiratory, vascular, and diabetes). Within each comorbidity, generalized linear mixed models were used to assess the association between treatment and continuous abstinence rates from weeks 9-12 to 9-24. Similar models were used to test the effect of number of comorbidities on abstinence.ResultsVarenicline resulted in the highest week 12 abstinence rates across all pharmacotherapies and compared to placebo in all comorbidity subgroups: Cardiac (40.0% vs. 3.6%; odds ratios [OR] = 23.3 [5.1-107.1]), respiratory (24.7% vs. 12.8%; OR = 2.2 [1.3-3.8]), vascular (29.1% vs. 10.4%; OR = 3.6 [2.3-5.7]), and diabetes (30.9% vs. 8.3%; OR = 6.5 [2.3-19.0]). This was maintained at week 24 for those with cardiac (23.3% vs. 1.8%; OR = 21.7 [2.7-178.2]), vascular (18.9% vs. 7.1%; OR = 3.1 [1.8-5.3]), and diabetes (20.6% vs. 4.2%; OR = 8.4 [2.1-33.7]) comorbidities. Treatment contrasts within some comorbidity subgroups revealed superior efficacy of varenicline over other pharmacotherapies. All pharmacotherapies increased the odds of abstinence regardless of number of comorbidities.ConclusionsVarenicline is the most efficacious option for patients with manageable cardiac, respiratory, vascular, and diabetes conditions to quit smoking, supporting recent clinical practice guidelines that recommend varenicline as first-line pharmacotherapy. Bupropion and NRT demonstrated efficacy for some comorbidity subgroups.ImplicationsThis secondary analysis of the EAGLES trial demonstrated that varenicline is the most efficacious option for patients with cardiac, respiratory, vascular, and diabetes diagnoses to quit smoking. This demonstration of varenicline efficacy among individuals with comorbid medical conditions supports recent clinical practice guidelines that recommend varenicline as a first-line pharmacotherapy for smoking cessation.

Project description:BackgroundConversational chatbots are an emerging digital intervention for smoking cessation. No studies have reported on the entire development process of a cessation chatbot.ObjectiveWe aim to report results of the user-centered design development process and randomized controlled trial for a novel and comprehensive quit smoking conversational chatbot called QuitBot.MethodsThe 4 years of formative research for developing QuitBot followed an 11-step process: (1) specifying a conceptual model; (2) conducting content analysis of existing interventions (63 hours of intervention transcripts); (3) assessing user needs; (4) developing the chat's persona ("personality"); (5) prototyping content and persona; (6) developing full functionality; (7) programming the QuitBot; (8) conducting a diary study; (9) conducting a pilot randomized controlled trial (RCT); (10) reviewing results of the RCT; and (11) adding a free-form question and answer (QnA) function, based on user feedback from pilot RCT results. The process of adding a QnA function itself involved a three-step process: (1) generating QnA pairs, (2) fine-tuning large language models (LLMs) on QnA pairs, and (3) evaluating the LLM outputs.ResultsWe developed a quit smoking program spanning 42 days of 2- to 3-minute conversations covering topics ranging from motivations to quit, setting a quit date, choosing Food and Drug Administration-approved cessation medications, coping with triggers, and recovering from lapses and relapses. In a pilot RCT with 96% three-month outcome data retention, QuitBot demonstrated high user engagement and promising cessation rates compared to the National Cancer Institute's SmokefreeTXT text messaging program, particularly among those who viewed all 42 days of program content: 30-day, complete-case, point prevalence abstinence rates at 3-month follow-up were 63% (39/62) for QuitBot versus 38.5% (45/117) for SmokefreeTXT (odds ratio 2.58, 95% CI 1.34-4.99; P=.005). However, Facebook Messenger intermittently blocked participants' access to QuitBot, so we transitioned from Facebook Messenger to a stand-alone smartphone app as the communication channel. Participants' frustration with QuitBot's inability to answer their open-ended questions led to us develop a core conversational feature, enabling users to ask open-ended questions about quitting cigarette smoking and for the QuitBot to respond with accurate and professional answers. To support this functionality, we developed a library of 11,000 QnA pairs on topics associated with quitting cigarette smoking. Model testing results showed that Microsoft's Azure-based QnA maker effectively handled questions that matched our library of 11,000 QnA pairs. A fine-tuned, contextualized GPT-3.5 (OpenAI) responds to questions that are not within our library of QnA pairs.ConclusionsThe development process yielded the first LLM-based quit smoking program delivered as a conversational chatbot. Iterative testing led to significant enhancements, including improvements to the delivery channel. A pivotal addition was the inclusion of a core LLM-supported conversational feature allowing users to ask open-ended questions.Trial registrationClinicalTrials.gov NCT03585231; https://clinicaltrials.gov/study/NCT03585231.

Dataset Information

A Randomized Controlled Trial Evaluating the Efficacy of E-Cigarette Use for Smoking Cessation in the General Population: E3 Trial Design.

Background

Methods

Conclusion

Publications

A Randomized Controlled Trial Evaluating the Efficacy of E-Cigarette Use for Smoking Cessation in the General Population: E3 Trial Design.

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