Nicotine Population Pharmacokinetics in Healthy Smokers After Intravenous, Oral, Buccal and Transdermal Administration.

Background: In 4 decades, numerous nicotine replacement therapy products have been developed. Population pharmacokinetic models can support exposure-response modeling and inform nicotine replacement therapy product development, but only limited model-based cross-study population pharmacokinetic analyses for nicotine replacement therapy products have been published.

Objectives: The aim of this retrospective analysis was to assess the population pharmacokinetics of nicotine across intravenous, oral, transdermal and oromucosal (mouth spray, chewing gum, lozenge and inhaler) routes and formulations in healthy smoking subjects.

A Time-to-Event Model Relating Integrated Craving to Risk of Smoking Relapse Across Different Nicotine Replacement Therapy Formulations.

Smoking increases the risk of cancer and other diseases, causing an estimated 7 million deaths per year. Nicotine replacement therapy (NRT) reduces craving for smoking, therefore, increasing an individual's probability to remain abstinent. In this work, we for the first time quantitatively described the relationship between craving and smoking abstinence, using retrospectively collected data from 19 studies, including 3 NRT formulations (inhaler, mouth spray, and patch) and a combination of inhaler and patch.

Relating Nicotine Plasma Concentration to Momentary Craving Across Four Nicotine Replacement Therapy Formulations.

Tobacco use is a major health concern. To assist smoking cessation, nicotine replacement therapy (NRT) is used to reduce nicotine craving. We quantitatively described the relationship between nicotine pharmacokinetics (PKs) from NRTs and momentary craving, linking two different pharmacodynamic (PD) scales for measuring craving.

Symptoms of nicotine toxicity in subjects achieving high cotinine levels during nicotine replacement therapy.

Introduction: Nicotine replacement therapy (NRT) aids smoking reduction and cessation. Although NRT is effective and safe, some smokers may achieve high nicotine levels. The purpose of this study was to determine the incidence and severity of nicotine-related adverse events in subjects with levels of cotinine, a metabolite of nicotine, that increased by >50% compared with baseline smoking in controlled clinical trials of NRT.

Efficacy of the nicotine inhaler in smoking reduction: A double-blind, randomized trial.

Many smokers are not ready to quit but are interested in changing their smoking behavior, particularly if such a change is associated with a reduction in health risk. The present study evaluated the efficacy of the nicotine inhaler in reducing smoking. Exploratory studies assessed whether reduction in smoking was associated with reduction in markers of disease risk.

Smoking cessation--but not smoking reduction--improves the annual decline in FEV1 in occupationally exposed workers.

Introduction: Individuals exposed both to cigarette smoke and respiratory pollutants at work incur a greater risk of development of airway hyperresponsiveness (AHR) and accelerated decline in forced expiratory volume in 1 s (FEV1) than that incurred by subjects undergoing each exposure separately. We examined whether smoking cessation or smoking reduction improves AHR and thereby slows down the decline in FEV1 in occupationally exposed workers.

Methods: We examined 165 workers (137 males and 28 females) participating in a smoking cessation programme.

Smoking reduction treatment with 4-mg nicotine gum: a double-blind, randomized, placebo-controlled study.

Background: Smoking reduction may provide a harm-reduction alternative treatment for smokers who are not ready to quit smoking. This study evaluated the efficacy of nicotine gum in helping smokers reduce or quit smoking.

Methods: This randomized, double-blind, placebo-controlled trial involved 364 smokers who were not ready to quit but were willing to reduce their smoking intensity.

Developmental history of the Glover-Nilsson smoking behavioral questionnaire.

Objective: To develop a simple, easily administered pencil-and-paper questionnaire to determine the degree to which behavioral patterns play a role in smoking dependence.

Methods: A modified Delphi technique was used to identify initial questions and to eliminate obvious duplications. Phase 2 utilized multiple statistical methods (principal components analysis, cluster analysis, stepwise multiple linear regression, cross tables, Mantel-Haenzel c2-test, and a Gamma test) to evaluate and reduce the number of questions from 18.

Effects of smoking cessation and reduction in asthmatics.

The present study examined the effect of smoking reduction and cessation on asthma regulation and biomarkers of exposure to cigarette smoke. In a prospective open design, we allocated 220 asthmatics among three groups: (a) Smoking reduction (reducers), with the aim of smoking fewer than seven cigarettes per day, (b) complete smoking cessation (abstainers), or (c) continuation of usual smoking (continuing smokers). Subjects used nicotine chewing gum or an oral nicotine inhaler to promote reduction and cessation.

Smoking reduction promotes smoking cessation: results from a double blind, randomized, placebo-controlled trial of nicotine gum with 2-year follow-up.

Aim: To test the effect of nicotine gum and placebo in smokers not motivated or not able to quit smoking with regard to smoking reduction and smoking cessation.

Design: This randomized study evaluated nicotine gum versus placebo for up to 1 year in 411 healthy smokers highly motivated to reduce cigarette use. Smoking reduction was defined as self-reported daily smoking less than 50% of baseline and any decrease (1 p.

Influence of long-term smoking reduction on health risk markers and quality of life.

We have recently published efficacy and safety data of a study using an oral nicotine inhaler in smoking reduction. The current analysis was undertaken to assess the secondary objectives of the trial: the influence of long-term smoking reduction on health risk markers. Four hundred healthy volunteers, unable or unwilling to stop smoking immediately, were enrolled in a double-blind, randomized, placebo-controlled trial in smoking reduction; 310 were evaluable up to 2 years.