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A randomized controlled trial of a smoking cessation self-help intervention for dual users of tobacco cigarettes and E-cigarettes: Intervention development and research design.

ABSTRACT: Electronic Nicotine Delivery Systems, also called electronic cigarettes or e-cigarettes, have been available for over a decade and use has been increasing dramatically. The primary reported reasons for use are to aid smoking cessation or reduction, yet a significant proportion appear to be long-term users of both products ("dual users"). Dual users may be motivated to quit smoking and might benefit from a behavioral intervention for smoking cessation. This paper describes the intervention development, as well as the design, methods, and data analysis plans for an ongoing randomized controlled trial (RCT). Formative research and learner verification were conducted to create a usable, understandable, and acceptable self-help intervention targeting dual users. The efficacy is being tested in an RCT with current dual users (N=2900) recruited nationally and randomized to one of three conditions. The Assessment Only (ASSESS) group only completes assessments. The Generic Self-Help (GENERIC) group receives non-targeted smoking cessation booklets and supplemental materials sent monthly over 18months. The e-cigarette Targeted Self-Help (eTARGET) group receives the newly developed intervention (targeted booklets and supplemental materials) sent over the same period. All participants complete self-report surveys every 3months over 2years. The primary study outcome is self-reported 7-day point prevalence abstinence. Cost-effectiveness metrics for the GENERIC and eTARGET interventions will also be calculated.

SUBMITTER: Meltzer LR

PROVIDER: S-EPMC5559662 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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A randomized controlled trial of a smoking cessation self-help intervention for dual users of tobacco cigarettes and E-cigarettes: Intervention development and research design.

Meltzer Lauren R LR Simmons Vani N VN Sutton Steven K SK Drobes David J DJ Quinn Gwendolyn P GP Meade Cathy D CD Unrod Marina M Brandon Karen O KO Harrell Paul T PT Eissenberg Thomas T Bullen Christopher R CR Brandon Thomas H TH

Contemporary clinical trials 20170622

Electronic Nicotine Delivery Systems, also called electronic cigarettes or e-cigarettes, have been available for over a decade and use has been increasing dramatically. The primary reported reasons for use are to aid smoking cessation or reduction, yet a significant proportion appear to be long-term users of both products ("dual users"). Dual users may be motivated to quit smoking and might benefit from a behavioral intervention for smoking cessation. This paper describes the intervention develo ...[more]

PMID: 28648969

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Project description:BackgroundAlthough many smokers use electronic cigarettes (e-cigarettes) to quit smoking, most continue to smoke while vaping. This dual use might delay cessation and increase toxicant exposure. We aimed to test the efficacy of a self-help intervention designed to help dual users to quit smoking.MethodsIn this three-arm randomised controlled trial we recruited individuals in the USA using Facebook and multimedia advertisements. Included participants were 18 years or older, smoked at least weekly in the preceding year, and vaped at least weekly in the preceding month. We used computer generated randomisation with balanced-permuted blocks (block size 10, with 2-4-4 ratio) to allocate participants to assessment only (ASSESS group), generic smoking cessation self-help booklets (GENERIC group), or booklets targeting dual users (eTARGET group). Individuals in the generic or targeted intervention groups received monthly cessation materials for 18 months, with assessments every 3 months for 24 months. The main outcome was self-reported 7-day point-prevalence smoking abstinence at each assessment point. All randomly allocated participants were included in primary analyses using generalised estimating equations for each of 20 datasets created by multiple imputation. Analysis of the χ2s produced an F test. The trial is registered with ClinicalTrials.gov, NCT02416011, and is now closed.FindingsBetween July 12, 2016, and June 30, 2017, we randomly assigned 2896 dual users (575 to assessment, 1154 to generic intervention, and 1167 to targeted self-help). 7-day point-prevalence smoking abstinence increased from 14% at 3 months to 42% at 24 months (F7,541·7=67·1, p<0·0001) in the overall sample. Targeted self-help resulted in higher smoking abstinence than did assessment alone throughout the treatment period (F1,973·8=10·20, p=0·0014 [α=0·017]). The generic intervention group had abstinence rates between those of the assessment and targeted groups, but did not significantly differ from either when adjusted for multiple comparisons (GENERIC vs eTARGET F1,1102·5=1·79, p=0·18 [α=0·05]; GENERIC vs ASSESS F1,676·7=4·29, p=0·039 [α=0·025]). Differences between study groups attenuated after the interventions ended.InterpretationA targeted self-help intervention with high potential for dissemination could be efficacious in promoting smoking cessation among dual users of combustible cigarettes and e-cigarettes.FundingNational Institute on Drug Abuse, National Cancer Institute.

Project description:Background and aimsMost e-cigarette users who also smoke combustible cigarettes (dual users) begin vaping to quit smoking, yet only a subset succeeds. We hypothesized that reinforcing characteristics of e-cigarettes (vaping reinforcement) would positively predict smoking cessation propensity (SCP) among dual users.DesignSecondary analysis of cross-sectional baseline data from dual users in an ongoing smoking cessation trial. Exploratory and confirmatory factor analysis (EFA and CFA) created latent variables for vaping reinforcement and SCP. A structural equation modeling (SEM) approach was used to test the hypothesis.SettingUnited States.ParticipantsA national sample of dual users of combustible and electronic cigarettes who smoke and vape at least once per week (n = 2896) were enrolled (63% male; mean age = 29.9 years) into a randomized controlled trial in which they would receive either smoking cessation materials or no smoking cessation materials.MeasurementsVaping reinforcement was indexed by vaping frequency (days/week vaping, times/day vaping, puffs/e-cigarette use), e-cigarette characteristics [numbers of modifications and tobacco or non-tobacco flavors, nicotine content (mg) and positive e-cigarette expectancies]. SCP was measured by items of confidence, commitment to being smoke-free, cessation motivation (contemplation ladder), change in cigarettes per day since beginning e-cigarette use and negative smoking expectancies.FindingsFour factors emerged from the EFA: vaping propensity (vaping frequency, positive expectancies), vaping enthusiasm (e-cigarette modifications, using non-tobacco flavors, puffs per use), nicotine/tobacco flavor (nicotine strength, tobacco flavors) and SCP (negative expectancies about smoking, motivation to quit smoking, reduction in smoking). A CFA upheld the exploratory factor structure [root mean square error of approximation (RMSEA) = 0.046, CFI = 0.91]. An SEM with the three vaping latent variables directly predicting SCP had good model fit (RMSEA = 0.030, CFI = 0.97) with a positive relationship of vaping propensity (0.509, P < 0.001), and small negative relationships of vaping enthusiasm (-0.158, P = 0.014) and nicotine/tobacco flavor (-0.230, P < 0.001).ConclusionsAmong e-cigarette users who also smoke combustible cigarettes, frequent vaping combined with positive e-cigarette expectancies appears to predict greater smoking cessation propensity. However, vaping enthusiasm (measured by e-cigarette modifications, using non-tobacco flavors and puffs per use), higher nicotine content and use of tobacco flavored solution may reduce cessation propensity.

Project description:IntroductionAn increasing number of parents use both e-cigarettes and cigarettes (dual users). Previous studies have shown that dual users may have higher rates of contemplating smoking cessation than parents who only smoke cigarettes. This study was aimed to assess the delivery of tobacco cessation treatment (prescription for nicotine replacement therapy and referral to the quitline) among parents who report being dual users vs. cigarette-only smokers.MethodsA secondary analysis of parent survey data collected between April and October 2017 at 10 pediatric primary care practices participating in a cluster-randomized controlled trial of the Clinical Effort Against Secondhand Smoke Exposure (CEASE) intervention was conducted. Parents were considered to be dual users of cigarettes and e-cigarettes if they reported smoking a cigarette, even a puff, in the past seven days and using an e-cigarette within the past 30 days. Parents were asked if they received a prescription for nicotine replacement therapy and referral to the quitline to help them quit from their child's clinician. Multivariable logistic regression examined factors (dual use, insurance status, relationship to the child, race, and education status of the parent) associated with delivery of smoking cessation treatment (receiving prescriptions and/or enrollment in quitline) to smoking parents. Further, we compared the rates of tobacco cessation treatment delivery to dual users in the usual-care control practices vs. intervention practices.ResultsOf 1007 smokers or recent quitters surveyed in the five intervention practices, 722 parents reported current use of cigarettes-only and 111 used e-cigarettes. Of these 111 parents, 82 (73.9%) reported smoking cigarettes. Parents were more likely to report receiving any treatment if they were dual users vs. cigarette-only smokers (OR 2.43, 95% CI 1.38, 4.29). Child's insurance status, parents' sex, education, and race were not associated with parental receipt of tobacco cessation treatment in the model. No dual users in the usual-care control practices reported receiving treatment. Discussion. Dual users who visited CEASE intervention practices were more likely to receive treatment than cigarette-only smokers when treatments were discussed. An increased uptake of tobacco cessation treatments among dual users reinforces the importance of discussing treatment options with this group, while also recognizing that cigarette-only smokers may require additional intervention to increase the acceptance rate of cessation assistance. This trial is registered with ClinicalTrials.gov, Identifier: NCT01882348.

Project description:BackgroundHeated tobacco products (HTPs) are widespread in Japan, and smoking cessation of such products has become an important issue owing to the spread of harmful effects from HTPs. The efficacy of online digital therapy has been reported in smoking cessation treatment; however, we have limited evidence of online smoking cessation programs for HTP users.ObjectiveIn this study, we evaluate the usefulness of the Ascure program for HTP users (defined as exclusive HTP use or dual use of HTP and cigarettes) compared with exclusive cigarette users.MethodsThis was a retrospective study. We recruited adult smokers participating in the Ascure online smoking cessation program in Japan from June 2019 to February 2021. The Ascure smartphone app provided four elements: (1) educational video tutorials to enhance the understanding of nicotine dependence, (2) a personalized to-do list for behavior change, (3) a digital diary for record keeping, and (4) interactive chat sessions for relief from cravings or withdrawal symptoms. The primary outcome was the continuous abstinence rate (CAR) at weeks 21 to 24, biochemically validated using salivary cotinine testing. We considered those who dropped out of the program as smoking cessation failures. We analyzed the primary outcome using inverse probability weighting against tobacco product type estimated by multinomial propensity scores. We also assessed CAR at weeks 9 to 12 and program adherence.ResultsWe analyzed data from 2952 participants, including 52% (1524/3478) in the cigarette group, 35% (1038/3478) in the HTP group, and 13% (390/3478) in the dual-use group, who had a mean age of 43.4 (SD 10.8) years and included 17% (513/2952) women. CAR at weeks 21 to 24 showed that exclusive HTP users were more likely to stop tobacco use than exclusive cigarette smokers (CAR 52.6% for cigarette users vs CAR 64.8% for HTP users; odds ratio [OR] 1.17, 95% CI 1.12-1.22; P<.001). There was no significant difference between the exclusive cigarette users and the dual users (CAR 52.6% for cigarette users vs CAR 48.7% for dual users; OR 0.99, 95% CI 0.93-1.05; P=.77). CAR at weeks 9 to 12 was 56.7% (95% CI 54.2%-59.2%) for the exclusive cigarette users, 68.3% (95% CI 65.5%-71.1%) for the exclusive HTP users, and 58.2% (95% CI 53.3%-63.1%) for the dual users. The program adherence rate at week 24 was 70.7% overall (68.4% for cigarette users, 75% for HTP users, and 67.9% for dual users).ConclusionsExclusive HTP users had higher CARs and adherence compared with exclusive cigarette users, indicating a higher affinity for the Ascure online smoking cessation program. This program might be a useful smoking cessation option for HTP users, as well as for cigarette smokers.

Dataset Information

A randomized controlled trial of a smoking cessation self-help intervention for dual users of tobacco cigarettes and E-cigarettes: Intervention development and research design.

Publications

A randomized controlled trial of a smoking cessation self-help intervention for dual users of tobacco cigarettes and E-cigarettes: Intervention development and research design.

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