Dataset Information

The role of nicotine replacement therapy in early quitting success.

ABSTRACT:

Introduction

Nicotine replacement therapy (NRT) is an effective but underutilized smoking cessation aid despite being available over the counter. This exploratory study examined whether voluntary early use of NRT predicted cessation in a self-initiated quit attempt better than other commonly studied variables.

Methods

Data were collected from 99 adult smokers desiring to quit smoking in the near future over a 10-day baseline period prior to the implementation of a contingency management intervention. NRT use was neither encouraged nor discouraged during the study. Initial abstinence, biochemically verified using a criterion of CO level <4 ppm, was conceptualized in 2 ways: (a) any day of baseline abstinence and (b) the sum of baseline days abstinent. We examined the predictive value of NRT use as well as demographics, self-efficacy, motivational readiness, and nicotine dependence.

Results

While greater self-efficacy was predictive of initial abstinence, NRT use was the most consistent predictor. The odds of abstaining at least 1 day during baseline were 16.8 times greater for those who used NRT on Day 1 than nonusers. Self-efficacy and "any baseline NRT use" contributed significant amounts of variance to the "sum of days abstinent," with the overall model explaining 29% of the variance (p < .001). The sum of baseline days of NRT use and use of NRT on Day 1 also predicted the "sum of days abstinent."

Discussion

Given NRT's effectiveness, but underutilization in real-world settings, the data support the need for interventions or strategies encouraging people to use NRT in their quit attempts.

SUBMITTER: Amodei N

PROVIDER: S-EPMC2802569 | biostudies-literature | 2010 Jan

REPOSITORIES: biostudies-literature

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Publications

The role of nicotine replacement therapy in early quitting success.

Amodei Nancy N Lamb R J RJ

Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco 20091106 1

<h4>Introduction</h4>Nicotine replacement therapy (NRT) is an effective but underutilized smoking cessation aid despite being available over the counter. This exploratory study examined whether voluntary early use of NRT predicted cessation in a self-initiated quit attempt better than other commonly studied variables.<h4>Methods</h4>Data were collected from 99 adult smokers desiring to quit smoking in the near future over a 10-day baseline period prior to the implementation of a contingency mana ...[more]

PMID: 19897526

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Project description:IntroductionNonadherence to pharmacotherapies complicates studies of comparative pharmacotherapy effectiveness. Modeling adherence and abstinence simultaneously may facilitate analysis of both treatment acceptability and effectiveness.MethodsSecondary analyses of a three-arm randomized comparative trial of nicotine patch, varenicline, and combination nicotine patch and lozenge among adult daily smokers (N = 1086) were conducted. Adherence rates collected via interactive voice response systems during the first 27 days of quitting were compared across treatment conditions. Repeated measures latent class analyses of adherence and abstinence in 3-day parcels through 27 days of a quit attempt were conducted with treatment, demographic, and smoking history covariates.ResultsAdherence varied across treatments and was lowest for nicotine lozenge use in combination nicotine replacement therapy (NRT). Five latent classes that differed significantly in 6-month abstinence rates were retained, including three subgroups of adherent participants varying in treatment response and two nonadherent groups varying in abstinence probabilities. Nonadherence was more likely among those receiving varenicline and combination NRT, relative to patch monotherapy. Varenicline and combination NRT did not promote abstinence among adherent latent classes but did promote abstinence among those partially adherent, relative to patch alone. Combination therapy attenuated increased risk of treatment disengagement with more years smoking. Minority smokers, those high in dependence, and those with shorter past abstinence were at increased risk for low-adherence and low-abstinence latent classes.ConclusionsVarenicline and combination nicotine patch and lozenge are less likely to be used as directed and may not increase first-month abstinence better than patch alone when taken adherently.ImplicationsThis secondary analysis of adherence and abstinence in a comparative effectiveness trial shows that adherence is highest for the nicotine patch, next highest for varenicline, and lowest for combination nicotine patch and lozenge therapy due to low lozenge use. Distinct latent classes were found that varied in both first-month abstinence and adherence. Varenicline and combination NRT may not enhance abstinence over patch alone among smokers who take medication adherently. Adherent use of medication especially benefits those who are low in dependence and have positive quitting histories; it is less beneficial to at-risk smokers and members of racial minorities.

Project description:The US Food and Drug Administration adopted labeling for nicotine patches to allow use beyond the standard 8 weeks. This decision was based in part on data showing increased efficacy for 24 weeks of treatment. Few studies have examined whether the use of nicotine patches beyond 24 weeks provides additional therapeutic benefit.To compare 8 (standard), 24 (extended), and 52 (maintenance) weeks of nicotine patch treatment for promoting tobacco abstinence.We recruited 525 treatment-seeking smokers for a randomized clinical trial conducted from June 22, 2009, through April 15, 2014, through 2 universities.Smokers received 12 smoking cessation behavioral counseling sessions and were randomized to 8, 24, or 52 weeks of nicotine patch treatment.The primary outcome was 7-day point prevalence abstinence, confirmed with breath levels of carbon monoxide at 6 and 12 months (intention to treat).At 24 weeks, 21.7% of participants in the standard treatment arm were abstinent, compared with 27.2% of participants in the extended and maintenance treatment arms (?(2)(1)?= 1.98; P =?.17). In a multivariate model controlled for covariates, participants in the extended and maintenance treatment arms reported significantly greater abstinence rates at 24 weeks compared with participants in the standard treatment arm (odds ratio [OR], 1.70 [95% CI, 1.03-2.81]; P =?.04), had a longer duration of abstinence until relapse (? = 21.30 [95% CI, 10.30-32.25]; P <?.001), reported smoking fewer cigarettes per day if not abstinent (mean [SD], 5.8 [5.3] vs 6.4 [5.1] cigarettes per day; ? = 0.43 [95% CI, 0.06-0.82]; P =?.02), and reported more abstinent days (mean [SD], 80.5 [38.1] vs 68.2 [43.7] days; OR, 1.55 [95% CI, 1.06-2.26]; P =?.02). At 52 weeks, participants in the maintenance treatment arm did not report significantly greater abstinence rates compared with participants in the standard and extended treatment arms (20.3% vs 23.8%; OR, 1.17 [95% CI, 0.69-1.98]; P =?.57). Similarly, we found no difference in week 52 abstinence rates between participants in the extended and standard treatment arms (26.0% vs 21.7%; OR, 1.33 [95% CI, 0.72-2.45]; P =?.36). Treatment duration was not associated with any adverse effects or adherence to the counseling regimen, but participants in the maintenance treatment arm reported lower adherence to the nicotine patch regimen compared with those in the standard and extended treatment arms (mean [SD], 3.94 [2.5], 4.61 [2.0], and 4.7 [2.4] patches/wk, respectively; F2,522 = 6.03; P =?.003).The findings support the safety of long-term use of nicotine patch treatment, although they do not support efficacy beyond 24 weeks of treatment in a broad group of smokers.clinicaltrials.gov Identifier: NCT01047527.

Project description:BACKGROUND:Nicotine, the pharmacologically active substance in both tobacco and many electronic cigarette (e-cigarette) liquids, is responsible for the addiction that sustains cigarette smoking. With 8 million deaths worldwide annually, smoking remains one of the major causes of disability and premature death. However, nicotine also plays an important role in smoking cessation strategies. OBJECTIVES:The aim of this study was to develop a comprehensive, whole-body, physiologically based pharmacokinetic/pharmacodynamic (PBPK/PD) model of nicotine and its major metabolite cotinine, covering various routes of nicotine administration, and to simulate nicotine brain tissue concentrations after the use of combustible cigarettes, e-cigarettes, nicotine gums, and nicotine patches. METHODS:A parent-metabolite, PBPK/PD model of nicotine for a non-smoking and a smoking population was developed using 91 plasma and brain tissue concentration-time profiles and 11 heart rate profiles. Among others, cytochrome P450 (CYP) 2A6 and 2B6 enzymes were implemented, including kinetics for CYP2A6 poor metabolizers. RESULTS:The model is able to precisely describe and predict both nicotine plasma and brain tissue concentrations, cotinine plasma concentrations, and heart rate profiles. 100% of the predicted area under the concentration-time curve (AUC) and maximum concentration (Cmax) values meet the twofold acceptance criterion with overall geometric mean fold errors of 1.12 and 1.15, respectively. The administration of combustible cigarettes, e-cigarettes, nicotine patches, and nicotine gums was successfully implemented in the model and used to identify differences in steady-state nicotine brain tissue concentration patterns. CONCLUSIONS:Our PBPK/PD model may be helpful in further investigations of nicotine dependence and smoking cessation strategies. As the model represents the first nicotine PBPK/PD model predicting nicotine concentration and heart rate profiles after the use of e-cigarettes, it could also contribute to a better understanding of the recent increase in youth e-cigarette use.

Dataset Information

The role of nicotine replacement therapy in early quitting success.

Introduction

Methods

Results

Discussion

Publications

The role of nicotine replacement therapy in early quitting success.

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