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Measures and predictors of varenicline adherence in the treatment of nicotine dependence.

ABSTRACT: INTRODUCTION:While adherence to medication in smoking cessation clinical trials is strongly associated with clinical outcome, very few studies have evaluated the validity of pill count as a measure of adherence relative to a biological assay, and evaluated a broad range of correlates of adherence. METHODS:In a smoking cessation clinical trial of varenicline, we compared pill counts collected over 4 different time periods to varenicline salivary levels taken after 2weeks of treatment, as well as evaluated predictors of adherence to varenicline. RESULTS:Using a binary measure of adherence based on salivary varenicline levels, adherence was higher among older, white, and more educated participants. Relative to 3, 7, and 14-day pill count, 12-week pill count was the only significant measure able to discriminate adherence as defined by salivary varenicline levels (assessed by area under the receiver operating characteristic curve; AUC=0.59, p=0.004). Seventy-two percent of participants who indicated adherence on 12-week pill count were classified as adherent based on varenicline saliva levels (sensitivity=0.80; specificity=0.40). There was modest variability in the relationship between 12-week pill count and varenicline levels across race and rate of nicotine metabolism. Lastly, General Estimating Equation models demonstrated that longitudinal changes in withdrawal, craving, negative and positive affect, and side effect count and severity were not related to adherence based on salivary varenicline levels. CONCLUSIONS:These results indicate that 12-week pill count was the best, albeit a relatively weak, measure of varenicline adherence; additional factors associated with treatment adherence need to be identified.

SUBMITTER: Peng AR

PROVIDER: S-EPMC5581992 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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Measures and predictors of varenicline adherence in the treatment of nicotine dependence.

Peng Annie R AR Morales Mark M Wileyto E Paul EP Hawk Larry W LW Cinciripini Paul P George Tony P TP Benowitz Neal L NL Nollen Nicole L NL Lerman Caryn C Tyndale Rachel F RF Schnoll Robert R

Addictive behaviors 20170712

<h4>Introduction</h4>While adherence to medication in smoking cessation clinical trials is strongly associated with clinical outcome, very few studies have evaluated the validity of pill count as a measure of adherence relative to a biological assay, and evaluated a broad range of correlates of adherence.<h4>Methods</h4>In a smoking cessation clinical trial of varenicline, we compared pill counts collected over 4 different time periods to varenicline salivary levels taken after 2weeks of treatme ...[more]

PMID: 28728040

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Project description:IntroductionThe number of cigarettes smoked per day (CPD) is a component of commonly used nicotine dependence measures and often used as a smoking cessation treatment outcome. Yet relighting (ie, smoking used cigarette butts) is not usually considered when CPD is assessed, which may underestimate nicotine dependence and result in an inaccurate picture of smoking behaviors.Aims and methodsData from a randomized controlled trial of a smoking cessation intervention were used. Fagerström Test for Cigarette Dependence (FTCD), CPD, and the frequency of smoking (number of smoking episodes/day) assessed at baseline and 3-month follow-up were used.ResultsParticipants were 49 adults with mood disorders who smoke daily receiving outpatient psychiatric treatment. At baseline, 27 (55.1%) participants reported relighting cigarettes, and 6 (27.3%) of those who did not report relighting at baseline reported relighting at 3-month follow-up. Replacing CPD with the frequency of smoking to recalculate the total FTCD score increased the score for 21 participants (43%). The mean FTCD scores increased from 4.61 to 5.16, from a classification of low to medium dependence, and 16 participants (33%) moved up in the dependence classification. Of the 31 participants who reported a >=50% reduction in CPD at 3-month follow-up, 5 (16%) did not achieve the outcome of >=50% reduction in the frequency of smoking per day.ConclusionsIn this sample of adults with mood disorders who smoke, over half reported relighting cigarettes. Results underscore the importance of incorporating the frequency of smoking/relighting when assessing nicotine dependence and patterns of smoking behaviors in high-risk populations.ImplicationsThis is the first study to investigate the patterns of relighting behavior and its impact on nicotine dependence and smoking cessation treatment outcome measures among treatment-seeking adults with mood disorders who smoke. The majority were relighting, and over a quarter of those who did not report relighting at baseline subsequently reported relighting in the context of a quit attempt. The findings demonstrate that overlooking relighting may underestimate nicotine dependence and overestimate the rates of those who have made meaningful changes in smoking behavior. Incorporating the frequency of smoking/relighting may help to more accurately capture nicotine dependence and patterns of smoking behavior among high-risk populations.

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Measures and predictors of varenicline adherence in the treatment of nicotine dependence.

Publications

Measures and predictors of varenicline adherence in the treatment of nicotine dependence.

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