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Factors Associated with Adherence to Transdermal Nicotine Patches within a Smoking Cessation Effectiveness Trial.

ABSTRACT: Background:Adherence to transdermal nicotine patches, one of the most popular and effective treatment for nicotine dependence, remains very low and is a strong predictor of cessation rates. This study examined individual factors related to adherence as well as differences over time between adherent (? 80% of daily patch use) and non-adherent participants (< 80% of daily patch use). Methods:We analyzed data from 440 participants who received 8 weeks of 21mg transdermal nicotine and 4 behavioral counseling sessions within an effectiveness trial that examined the effects of long-term treatment. Multiple logistical regression assessed baseline variables associated with patch adherence and generalized estimating equations (GEE) were used to evaluate changes in craving and withdrawal, depressive and anxiety symptoms, substitute and complementary reinforcers, and side effects between participants who were or were not adherent. Results:In a logistic regression model, being female, living with a child or children, and higher self-reported anxiety symptoms were predictive of lower patch adherence (p < .05). In the GEE analysis, adherence was significantly associated with: a greater reduction in craving, a greater engagement in substitute reinforcers, and a greater decrease in complementary reinforcers over time (p < .05). Conclusions:Difficulties adhering to transdermal nicotine patches may be related to psychiatric comorbidity, difficulty managing nicotine craving, and challenges with engaging in substitute reinforcers and reducing exposure to complementary reinforcers. These constructs may serve as targets for interventions designed to increase treatment adherence.

SUBMITTER: Handschin J

PROVIDER: S-EPMC6586235 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Factors Associated with Adherence to Transdermal Nicotine Patches within a Smoking Cessation Effectiveness Trial.

Handschin Jonnie J Hitsman Brian B Blazekovic Sonja S Veluz-Wilkins Anna A Wileyto E Paul EP Leone Frank T FT Schnoll Robert A RA

Journal of smoking cessation 20170309 1

<h4>Background</h4>Adherence to transdermal nicotine patches, one of the most popular and effective treatment for nicotine dependence, remains very low and is a strong predictor of cessation rates. This study examined individual factors related to adherence as well as differences over time between adherent (≥ 80% of daily patch use) and non-adherent participants (< 80% of daily patch use).<h4>Methods</h4>We analyzed data from 440 participants who received 8 weeks of 21mg transdermal nicotine and ...[more]

PMID: 31223345

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Project description:Some smokers may benefit from a therapy that combines different nicotine replacement therapies (NRT) or drugs with different mechanisms of action.The aim of this study was to determine the efficacy of the combined therapy of varenicline and nicotine patches versus varenicline monotherapy.Three hundred forty-one smokers who smoked 20 or more cigarettes per day were recruited from a smoking cessation clinic between February 2012 and June 2013. The participants were randomized to receive a varenicline plus nicotine patch of 21 mg every 24 hours (170) or varenicline plus a placebo patch (171). All of the smokers received a standard 12-week course of varenicline and an 11-week course of either the placebo patch or the active patch after the target quit day. Both groups received behavioral support. The primary outcome was continuous abstinence for weeks 2 through 12 confirmed by exhaled levels of carbon monoxide. Post hoc subgroup analyses were performed to evaluate the treatment effects for a specific endpoint in subgroups of smokers.The combination of the nicotine patch with varenicline was not associated with higher rates of continuous abstinence at 12 weeks (39.1% versus 31.8%; odds ratio (OR) 1.24; 95% confidence interval (CI) 0.8 to 2.6) and 24 weeks (32.8% versus 28.2%; OR 1.17; 95% CI 0.4 to 1.9). When participants were analyzed by subgroups according to cigarette consumption, the abstinence rates among smokers who smoked more than 29 cigarettes per day at 12 weeks (OR 1.39; 95% CI 1.2 to 2.5) and 24 weeks (OR 1.46; 95% CI 1.2 to 2.8) were significantly higher in the combination group. Other post hoc analyses based on level of dependence and previous quit attempts did not show subgroup differences. No differences between the groups for the reported adverse events were observed (?2 value 0.07; P 0.79).The combination of varenicline with the nicotine patch does not improve abstinence rates at 12 and 24 weeks compared with varenicline used as monotherapy when all smokers were analyzed as a whole, independent of consumption level.This study is registered at clinicaltrial.gov (NCT01538394).

Project description:INTRODUCTION:Evidence indicates e-cigarettes can help people quit smoking; however, more confirmatory trials are needed. To date, no trials have evaluated the effectiveness and safety of combining nicotine patches with e-cigarettes (with and without nicotine) for smoking cessation. METHODS AND ANALYSIS:This study is a pragmatic, three-arm, community-based, single-blind, randomised trial undertaken in New Zealand. Eligible participants are daily/non-daily smokers, aged ?18 years, naive e-cigarette users and motivated to quit smoking in the next 2?weeks. Participants (n=1809), recruited using multi-media advertising, are randomised to 14 weeks of (1) 21?mg nicotine patches (n=201); (2) 21?mg nicotine patches+18?mg/mL nicotine e-cigarette (n=804); or (3) 21?mg nicotine patches+nicotine?free e-cigarette (n=804). Participants receive weekly withdrawal-oriented behavioural support calls for 6?weeks post-randomisation. The primary outcome is self-reported biochemically verified continuous abstinence (CA) at 6?months post quit-date. The primary comparison is nicotine patch + nicotine?e-cigarette versus nicotine patch + nicotine?free e-cigarette, and the secondary comparison is nicotine patch versus nicotine patch +nicotine?e-cigarette (90% power, p=0.05, to detect an absolute difference in 6?month CA rates of 8% and 15% respectively). Secondary outcomes, collected by phone interview at quit date, then 1, 3, 6 and 12 months post-quit date, include self-reported CA, 7?day point prevalence abstinence, cigarettes per day (if smoking, or when smoking for non-daily smokers), time to relapse (if returned to smoking), belief in ability to quit, use of other cessation support, side effects/serious adverse events, treatment compliance, seeking additional support around e-cigarette use, daily use of both e-cigarettes and cigarettes, use of treatment past 14 weeks, views on treatment and recommendation to others, weight and cost-per-quitter. ETHICS AND DISSEMINATION:The Northern A Health and Disability Ethics Committee approved the trial. Findings will be disseminated through publication, conference/meeting presentations, and media. TRIAL REGISTRATION NUMBER:NCT02521662; Pre-results.

Project description:BackgroundVarenicline, a new treatment for smoking cessation, has demonstrated significantly greater efficacy over placebo and sustained release bupropion (bupropion SR). A study was undertaken to compare a 12-week standard regimen of varenicline with a 10-week standard regimen of transdermal nicotine replacement therapy (NRT) for smoking cessation.MethodsIn this 52-week, open-label, randomised, multicentre, phase 3 trial conducted in Belgium, France, The Netherlands, UK and USA, participants were randomly assigned (1:1) to receive varenicline uptitrated to 1 mg twice daily for 12 weeks or transdermal NRT (21 mg/day reducing to 7 mg/day) for 10 weeks. Non-treatment follow-up continued to week 52. The primary outcome was the biochemically confirmed (exhaled carbon monoxide < or = 10 ppm) self-reported continuous abstinence rate (CAR) for the last 4 weeks of the treatment period in participants who had taken at least one dose of treatment. Secondary outcomes included CAR from the last 4 weeks of treatment through weeks 24 and 52, and measures of craving, withdrawal and smoking satisfaction.ResultsA total of 376 and 370 participants assigned to varenicline and NRT, respectively, were eligible for analysis. The CAR for the last 4 weeks of treatment was significantly greater for varenicline (55.9%) than NRT (43.2%; OR 1.70, 95% CI 1.26 to 2.28, p<0.001). The week 52 CAR (NRT, weeks 8-52; varenicline, weeks 9-52) was 26.1% for varenicline and 20.3% for NRT (OR 1.40, 95% CI 0.99 to 1.99, p = 0.056). Varenicline significantly reduced craving (p<0.001), withdrawal symptoms (p<0.001) and smoking satisfaction (p<0.001) compared with NRT. The most frequent adverse event was nausea (varenicline, 37.2%; NRT, 9.7%).ConclusionsThe outcomes of this trial established that abstinence from smoking was greater and craving, withdrawal symptoms and smoking satisfaction were less at the end of treatment with varenicline than with transdermal NRT.Trial registration numberNCT00143325.

Project description:Abstinence reinforcement is efficacious for improving smoking treatment outcomes, but practical constraints related to the need for multiple in-person carbon monoxide (CO) breath tests daily to verify smoking abstinence have limited its use. This study tested an mHealth procedure to remotely monitor and reinforce smoking abstinence in individuals' natural environment.Eligible treatment-seeking smokers (N = 90) were randomized to (1) usual care and ecological monitoring with abstinence reinforcement (mHealth reinforcement) or (2) without reinforcement (mHealth monitoring). Usual care was 8 weeks of transdermal nicotine and twice-weekly telephone counseling. Following training, an interactive voice response system prompted participants to conduct CO tests 1-3 daily at pseudorandom times (7 am to 10 pm) for 4 weeks. When prompted, participants used a study cell phone and CO monitor to complete a CO self-test, video record the process, and submit videos using multimedia messaging. mHealth reinforcement participants could earn prizes for smoking-negative on-time CO tests. The interactive voice response generated preliminary earnings immediately. Earnings were finalized by comparing video records against participants' self-reports.mHealth reinforcement was associated with a greater proportion of smoking-negative CO tests, longest duration of prolonged abstinence, and point-prevalence abstinence during the monitoring/reinforcement phase compared to mHealth monitoring (p < .01, d = 0.8-1.3). Follow-up (weeks 4-24) analyses indicated main effects of reinforcement on point-prevalence abstinence and proportion of days smoked (p ? .05); values were comparable by week 24.mHealth reinforcement has short-term efficacy. Research on methods to enhance and sustain benefits is needed.This study suggests that mHealth abstinence reinforcement is efficacious and may present temporal and spatial opportunities to research, engage, and support smokers trying to quit that do not exist with conventional (not technology-based) reinforcement interventions.

Project description:Tobacco dependence is a chronic, relapsing condition that may require extended treatment.To assess whether extended-duration transdermal nicotine therapy increases abstinence from tobacco more than standard-duration therapy in adult smokers.Parallel randomized, placebo-controlled trial from September 2004 to February 2008. Participants and all research personnel except the database manager were blinded to randomization. (ClinicalTrials.gov registration number: NCT00364156)Academic center.568 adult smokers.In an unstratified small block-randomization scheme, participants were randomly assigned to standard therapy (Nicoderm CQ [GlaxoSmithKline, Research Triangle Park, North Carolina], 21 mg, for 8 weeks and placebo for 16 weeks) or extended therapy (Nicoderm CQ, 21 mg, for 24 weeks).The primary outcome was biochemically confirmed point-prevalence abstinence at weeks 24 and 52. Secondary outcomes were continuous and prolonged abstinence, lapse and recovery events, cost per additional quitter, and side effects and adherence.At week 24, extended therapy produced higher rates of point-prevalence abstinence (31.6% vs. 20.3%; odds ratio, 1.81 [95% CI, 1.23 to 2.66]; P = 0.002), prolonged abstinence (41.5% vs. 26.9%; odds ratio, 1.97 [CI, 1.38 to 2.82]; P = 0.001), and continuous abstinence (19.2% vs. 12.6%; odds ratio, 1.64 [CI, 1.04 to 2.60]; P = 0.032) versus standard therapy. Extended therapy reduced the risk for lapse (hazard ratio, 0.77 [CI, 0.63 to 0.95]; P = 0.013) and increased the chances of recovery from lapses (hazard ratio, 1.47 [CI, 1.17 to 1.84]; P = 0.001). Time to relapse was slower with extended versus standard therapy (hazard ratio, 0.50 [CI, 0.35 to 0.73]; P < 0.001). At week 52, extended therapy produced higher quit rates for prolonged abstinence only (P = 0.027). No differences in side effects and adverse events between groups were found at the extended-treatment assessment.The generalizability of the findings may be limited because participants were smokers without medical comorbid conditions who were seeking treatment, and differences in adherence across treatment groups were detected.Transdermal nicotine for 24 weeks increased biochemically confirmed point-prevalence abstinence and continuous abstinence at week 24, reduced the risk for smoking lapses, and increased the likelihood of recovery to abstinence after a lapse compared with 8 weeks of transdermal nicotine therapy.National Institutes of Health.

Project description:Background and aimsWithin the context of busy clinical settings, health-care providers need practical, evidence-based options to engage smokers in quitting. Sampling of nicotine replacement therapy [i.e. provision of nicotine replacement therapy (NRT starter kits)] is a brief, pragmatic strategy to address this need. We aimed to compare the effects of NRT sampling plus standard care (SC), relative to SC alone, provided by primary care providers during routine clinic visits.DesignCluster-randomized clinical trial.SettingTwenty-two primary care clinics in South Carolina, USA.ParticipantsAdult smokers [n = 1245; 61% female, mean age = 50.7, standard deviation (SD) = 13.5] both motivated and unmotivated to quit, seen during routine clinical visit. Interventions were provider-delivered SC (n = 652, 12 clinics) cessation advice or SC + a 2-week supply of both nicotine patch and lozenge, with minimal instructions on use (n = 593; 10 clinics).MeasurementsThe primary outcome was 7-day point prevalence smoking abstinence at 6-month follow-up, using intent-to-treat. Additional outcomes included NRT use and quit attempts, assessed at 1, 3 and 6 months following baseline.FindingsSeven-day point prevalence abstinence rates were significantly higher in the NRT sampling group throughout follow-up, including at 6 months [12 versus 8%, odds ratio (OR) = 1.5, 95% confidence interval (CI) = 1.0-2.4]. NRT sampling increased prevalence of any use of NRT (65 versus 25%, OR = 5.8, 95% CI = 4.3-7.7), with higher prevalence of use at 6 months (25 versus 14%, OR = 2.0, 95% CI = 1.5-2.7). NRT sampling increased the rate of quit attempts in the initial month (24 versus 18%, OR = 1.5, 95% CI = 1.0-2.3) but had no significant effect on overall rate of quit attempts (48 versus 45%, OR = 1.2, 95% CI = 0.8-1.7).ConclusionProviding smokers with a free 2-week starter kit of nicotine replacement therapy increased quit attempts, use of stop smoking medications and smoking abstinence compared with standard care in a primary care setting.

Dataset Information

Factors Associated with Adherence to Transdermal Nicotine Patches within a Smoking Cessation Effectiveness Trial.

Publications

Factors Associated with Adherence to Transdermal Nicotine Patches within a Smoking Cessation Effectiveness Trial.

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