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

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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: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: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.

Project description:ImportanceCigarette smoking during pregnancy increases the risk of preterm birth, low birth weight, and infant mortality.ObjectiveTo assess the probability of preterm birth among expectant mothers who smoked cigarettes before pregnancy and quit smoking at the start or during pregnancy.Design, setting, and participantsThis cross-sectional study analyzed information provided on live birth certificates from 2011 through 2017 that were obtained from US states that implemented the 2003 revision of the US live birth certificate. In total, 25?233?503 expectant mothers who delivered live neonates and had known prepregnancy and trimester-specific cigarette smoking frequency were included in the analyses.ExposuresCigarette smoking frequency (1-9, 10-19, and ?20 cigarettes per day) 3 months prior to pregnancy and for each trimester during pregnancy.Main outcomes and measuresCigarette smoking cessation throughout pregnancy, after the first trimester, after the second trimester, and during the third trimester irrespective of first and second trimester smoking. Probability of preterm birth (<37 weeks' gestation).ResultsOf 25?233?503 expectant mothers who delivered live neonates between 2011 and 2017, the modal age at delivery was 25 to 29 years; 52.9% were non-Hispanic white, 23.6% were Hispanic, and 14.2% were non-Hispanic black women; 22?600?196 mothers did not smoke during the 3 months prior to pregnancy, and 2?633?307 smoked during the 3 months prior to pregnancy. The proportion of prepregnancy smokers who quit throughout pregnancy was 24.3% in 2011 and 24.6% in 2017. The proportion of prepregnancy smokers who quit during the third trimester was 39.5% in 2011 and 39.7% in 2017. High-frequency cigarette smoking often occurred among expectant mothers who smoked during pregnancy (eg, 46.9% of third-trimester smokers smoked ?10 cigarettes per day in 2017). The probability of preterm birth decreased more the earlier smoking cessation occurred in pregnancy. For example, the probability of preterm birth was 9.8% (95% CI, 9.7%-10.0%) among 25- to 29-year-old, non-Hispanic white, primigravida and primiparous expectant mothers (ie, pregnant for the first time and not yet delivered) who smoked 1 to 9 cigarettes per day prior to pregnancy and maintained this frequency throughout their pregnancy. The probability of preterm birth was 9.0% (95% CI, 8.8%-9.1%) if smoking cessation occurred at the start of the second trimester (an 8.9% relative decrease), and 7.8% (95% CI, 7.7%-8.0%) if cessation occurred at the start of pregnancy (a 20.3% relative decrease).Conclusions and relevanceQuitting smoking-and quitting early in pregnancy-was associated with reduced risk of preterm birth even for high-frequency cigarette smokers.

Dataset Information

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

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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