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PubMedDate not supplied

Nicotine dependence: a preventable risk factor for other diseases.

Nicotine meets all critical criteria for an addictive drug. Furthermore, there is no evidence that there would be widespread compulsive use of tobacco without nicotine. These findings have led to consideration of the cigarette as a contaminated vehicle for an addictive drug (nicotine). Nevertheless, nicotine itself may also be used therapeutically to reduce exposure to carcinogens and other tobacco toxins. Nicotine replacement is a useful adjunct in treating tobacco dependence. For example, nicotine replacement in the form of a polacrilex resin (chewing gum) can alleviate physically based signs and symptoms of tobacco abstinence. The fact that this form of nicotine replacement is not attractive to non-users of tobacco has opened the door to the use of nicotine in a therapeutic modality, permitting hope of eliminating tobacco dependence.

Chewing Gum↗
PubMed2005

Safety profile of a nicotine lozenge compared with that of nicotine gum in adult smokers with underlying medical conditions: a 12-week, randomized, open-label study.

BACKGROUND: Nicotine polacrilex lozenges deliver 25% to 27% more nicotine compared with equivalent doses of nicotine polacrilex gum. The increased nicotine exposure from the lozenge has raised questions about the relative safety of the lozenge and gum. OBJECTIVE: The objective of this study was to compare the safety profiles of the 4-mg nicotine lozenge and 4-mg nicotine gum in smokers with selected label-restricted diseases. METHODS: This was a multicenter, randomized, open-label study in adult smokers with heart disease, hypertension not controlled by medication, and/or diabetes mellitus. Patients were randomized in a 1:1 ratio to receive the 4-mg nicotine lozenge or 4-mg nicotine gum. Safety assessments were made at baseline and at 2, 4, 6, and 12 weeks after the start of product use. RESULTS: Nine hundred one patients were randomized to treatment, 447 who received the lozenge and 454 who received the gum (safety population). The majority were women (52.7%). Patients' mean age was 53.9 years, their mean weight was 193.9 pounds, and they smoked a mean of 25.2 cigarettes per day at baseline. Five hundred fifty-three patients, 264 taking the lozenge and 289 taking the gum, used the study product for > or =4 days per week during the first 2 weeks (evaluable population). The nicotine lozenge and nicotine gum were equally well tolerated, despite increased nicotine exposure from the lozenge. The incidence of adverse events in the 2 groups was similar during the first 2 weeks of product use (evaluation population: 55.3% lozenge, 54.7% gum), as well as during the entire study (safety population: 63.8% and 58.6%, respectively). Stratification of patients by sex, age, extent of concurrent smoking, extent of product use, and severity of adverse events revealed no clinically significant differences between the lozenge and gum. The most common adverse events were nausea (17.2% and 16.1%; 95% CI, -3.7 to 6.0), hiccups (10.7% and 6.6%; 95% CI, 0.5 to 7.8), and headache (8.7% and 9.9%; 95% Cl, -5.0 to 2.6). Serious adverse events were reported in 11 and 13 patients in the respective groups. Fewer than 6% of patients in either group were considered by the investigator to have a worsening of their overall disease condition during the study. The majority of patients (>60%) experienced no change in their disease status from baseline. CONCLUSION: The 4-mg nicotine lozenge and 4-mg nicotine gum had comparable safety profiles in these patients with label-restricted medical conditions.

Algorithms↗
PubMed2003

Pharmacokinetics of a nicotine polacrilex lozenge.

To evaluate the pharmacokinetic characteristics of the 2-mg and 4-mg nicotine polacrilex lozenges, the following four separate studies were conducted in healthy adult smokers: (a) A single-dose, four-way crossover (replicate design) study to compare the 4-mg lozenge and the 4-mg nicotine polacrilex gum, (b) a single-dose, two-way crossover study to compare the 2-mg lozenge and the 2-mg gum, (c) a multiple-dose, four-way crossover study to compare the lozenges administered every 90 min and the gums administered every 60 min at 2- and 4-mg dose levels, and (d) a single-dose, three-way crossover study to compare the pharmacokinetic profiles of the 4-mg lozenge when administered in three different ways: (i) Used as directed, (ii) chewed and immediately swallowed, and (iii) chewed, retained in the mouth for 5 min, and then swallowed. The single-dose studies consistently demonstrated 8%-10% higher maximal plasma concentrations and 25%-27% higher AUC values (area under the concentration-time curve) from the lozenges compared with the gums at the 2- and 4-mg dose levels, probably owing to the residual nicotine retained in the gum. The multiple-dose study applying different dosing intervals (i.e., every 90 min for the lozenges and every 60 min for the gums) resulted in approximately 30% lower AUC(0-t) values for the lozenges compared with those for the gums. Administration of the lozenge contrary to the label-specified instructions for use did not lead to a faster or higher absorption of nicotine. These pharmacokinetic characteristics should allow the lozenge to become an effective and safe therapeutic alternative for smoking cessation.

Administration, Oral↗
PubMed2005

Comparative efficacy of rapid-release nicotine gum versus nicotine polacrilex gum in relieving smoking cue-provoked craving.

AIMS: Most relapse episodes occur when smokers are confronted with craving provoked by situational cues. Current nicotine gum can help relieve cue-provoked cravings, but faster effects may result in more rapid relief. We tested a prototype formulation of a new rapid-release nicotine gum (RRNG) that provides more rapid release and absorption of nicotine, for its ability to provide faster and better craving relief compared to current nicotine polacrilex gum (NPG). DESIGN: Random assignment to RRNG or NPG, used during a smoking cue provocation procedure. Participants and setting A total of 319 smokers were exposed to a smoking cue in the laboratory by being asked to light but not smoke a cigarette of their preferred brand. Subjects then chewed a piece of 2 mg RRNG (n = 159) or 2 mg NPG (n = 160) according to randomized assignment. MEASUREMENTS: Craving assessments were completed at regular intervals before and after cue exposure (baseline, pre-cue, and 3, 6, 9, 12, 15, 18, 21, 25, 30 and 35 minutes after the cue). FINDINGS: Smokers chewing RRNG showed significantly lower craving than NPG subjects starting with the first assessment at 3 minutes (P < 0.025). Repeated-measures ANOVA revealed a significant treatment x time interaction (P < 0.05)-craving scores dropped more rapidly in RRNG subjects compared to NPG subjects. Survival analyses also indicated superiority of RRNG in achieving more rapid self-reported meaningful relief (P < 0.05) and complete relief (P < 0.05) of craving. CONCLUSIONS: Rapid-release nicotine gum reduced cue-provoked craving more rapidly compared to NPG, and thus merits further study in cessation efficacy trials.

Adolescent↗
PubMed2000

Development of major depression after treatment for smoking cessation.

OBJECTIVE: Case studies suggest cigarette abstinence may precipitate a major depressive episode. This study examined the incidence and predictors of major depression in the 12 months after treatment for smoking cessation. METHOD: Participants (N=304, 172 women) were recruited from two trials of smoking cessation. Both trials provided psychological group intervention, but one group received treatment with nicotine gum and the other was given nortriptyline or placebo. The incidence of major depressive episodes was identified by the Inventory to Diagnose Depression, which was administered at follow-up assessments. RESULTS: The 12-month incidence of major depression after treatment for smoking cessation was 14.1% (N=43). Multiple logistic regression analyses indicated that history of depression, baseline Beck Depression Inventory score, college education, and age at smoking initiation were significant predictors of major depression after treatment. Abstinence at the end of treatment did not significantly predict major depression. CONCLUSIONS: Patients who achieved abstinence from smoking showed a risk of developing depressive episodes similar to those who failed to achieve abstinence. As expected, patients who had a history of depression were more likely to experience depressive episodes after treatment for smoking cessation. The 12-month incidence of major depression in this study group was higher than that observed in the general population, but reasons for the elevation were not clear.

Adult↗
PubMed2001

Tobacco cessation, the dental profession, and the role of dental education.

This article describes the development of a comprehensive, interdisciplinary, tobacco cessation program based on twenty years of experience at the Indiana University (IU) School of Dentistry. It reviews the relationship between tobacco use and oral health, the nature of nicotine addiction and cessation approaches involving nicotine replacement therapy. In the early 1980s, tobacco control curriculum and cessation guidelines were introduced at the IU School of Dentistry and cooperative efforts initiated with other U.S. and Canadian dental schools. During the past decade, an interdisciplinary Nicotine Dependence Program has been developed to serve outpatients receiving treatment at all hospitals on the IU Medical Center campus. It is hoped that the models described here will be of value to other dental schools developing educational curricula and tobacco control and cessation programs.

Central Nervous System Stimulants↗
PubMed2000

Treatment of nicotine addiction.

The best available data show smoking to be by far the most important cause of disease and death in our society, contributing to an average of 1000 deaths every day. Although a large majority of current smokers express a desire to quit, the majority of "self-help" attempts to quit are not successful. Further, most smokers indicate never having received advice on cessation from healthcare providers. The combination of pharmacotherapy and behavioral interventions, even on a minimal level, have been shown to be effective in cessation. Such strategies are certainly highly cost-effective, given the enormous costs to society of smoking-related illnesses. Therefore, it is important that all healthcare providers provide at least some form of smoking cessation programs for their patients.

Administration, Cutaneous↗
PubMed1992

Tobacco dependence and the nicotine patch. Clinical guidelines for effective use.

OBJECTIVE: A comprehensive review of transdermal nicotine treatment for tobacco dependence, with recommendations derived from the research literature. DATA SOURCES: English-language clinical trials. STUDY SELECTION: Clinical trials using placebo-controlled, double-blind methodology (11 studies) with at least 6 months of follow-up after treatment (eight studies) and biochemical verification of smoking status. DATA SYNTHESIS: Nicotine patches produce end-of-treatment smoking cessation rates that range from 18% to 77%; these rates are about twice those of placebo-treated subjects. Nicotine patches produced 6-month abstinence rates of 22% to 42%, while placebo patches produced quit rates of 5% to 28%. Nicotine patches appear to reduce some, but not all, nicotine withdrawal symptoms. For instance, while the patch reduces craving for cigarettes and negative moods, it does not appear to reduce hunger or weight gain. The clinical trials literature suggests that proper adjuvant smoking cessation counseling is crucial in determining successful long-term outcome with the nicotine patch, and suggests that 6 to 8 weeks of patch therapy may be an adequate duration for most patients. CONCLUSIONS: Nicotine patches are an effective aid to tobacco dependence treatment. However, success rates vary greatly across research studies and may be influenced highly by the nature and intensity of adjuvant smoking cessation counseling. More research is needed to identify optimal duration, dosage, and individualization of patch therapy. The impact of nicotine patches (more than 5 million users with $1 billion in sales for 1992) also raises important ethical and public health issues.

Administration, Cutaneous↗
PubMed2005

Tobacco cessation for the dental team: a practical guide part II: evidence-based interventions.

Dental professionals are strategically placed to be the leaders in tobacco prevention and cessation as they provide preventive and therapeutic services to a basically healthy population on a regular basis. By expanding the dental exam, diagnosis, and treatment to include tobacco cessation, a potentially life saving element of care is added to an established service. In addition periodontal disease and the potential for oral cancer mandate the inclusion of tobacco cessation services into dental care. Though dental professionals are aware of the health issues associated with tobacco use, they often feel ill prepared or uncomfortable presenting patients with a clear cessation message. In this, the second of a two-part article, the purpose is to provide dental professionals with the evidence-based strategies necessary to provide effective tobacco cessation as a normal part of patient care.

Bupropion↗
PubMed1991

[Tobacco addiction and its treatment using replacement therapy].

Tobacco or nicotine dependence is now established as a disease and listed by several countries and by the World Health Organization. The characteristics and mechanisms of tobacco dependency will be described as well as its assessment and implications for treatment.

Chewing Gum↗