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Aims: To determine the efficacy and safety of nicotine transdermal therapy co-administered with the nicotine antagonist, mecamylamine, compared to a nicotine transdermal patch alone (21 mg nicotine + 6 mg mecamylamine, 21 mg nicotine + 3 mg mecamylamine, and 21 mg nicotine + 0 mg mecamylamine)., Design: Multi-center (n = 4), double-blind, randomized, parallel group, repeat-dose study., Setting: Clinical laboratory., Participants: A total of 540 subjects were enrolled into the study-135 from each of four sites; 180 patients in each of three treatment arms., Intervention: Treatment was administered for the first 6 weeks of the 8-week study. Patients were instructed to continue smoking for the first 2 weeks of treatment., Measurements: The primary efficacy parameter was 4-week continuous abstinence after the quit date, confirmed with an expired carbon monoxide of < 10 parts per million., Findings: Analysis of the 4-week continuous abstinence for the intent-to-treat population showed overall rates of 29% (nicotine + 6 mg mecamylamine), 29% (nicotine + 3 mg mecamylamine) and 23% (nicotine only) using the slip definition which allows smoking in the first 2 weeks after the quit date. Statistical analyses revealed no significant treatment differences. Analyses using the strict definition (no smoking after the quit date) yielded similar non-significant group differences (29%, 27%, 26%)., Conclusion: If adding mecamylamine to nicotine replacement therapy (NRT) improves the chances of success at stopping smoking, the results of this study suggest that the effect is very small.

As Indiana dentists become involved in office-based smoking cessation efforts, they can prescribe the recently-developed Federal Drug Administration (FDA)-approved nicotine transdermal patch delivery systems for their smoking patients who wish to overcome nicotine addiction. This article reviews the evolutionary and scientific development of transdermal nicotine patch systems within an oral health setting. It discusses dental office-based cessation programs which have been designed by faculty members at the Indiana University School of Dentistry and by dentists who work with the National Cancer Institute. Finally, it presents the rationale for patch usage and specific techniques which are utilized in prescribing and monitoring this medication.

A double-blind clinical trial was conducted to determine whether the use of a chewing gum containing 2.0 mg nicotine (as an adjunct to a stop-smoking program) had any effects upon oral health. A total of 193 adults who smoked cigarettes volunteered with informed consent, were given routine dental prophylaxes, and were examined for the presence of plaque, stained pellicle, gingivitis, calculus, and general oral pathosis. The subjects were then randomly assigned to use either a nicotine-containing or a placebo chewing gum. After 15 weeks the subjects were recalled and re-examined. Smoking cessation was determined through questionnaire and analysis of the carbon monoxide content of alveolar air. At the completion of the study, 79 subjects had used the placebo gum and 78 had used the nicotine gum. Data analysis indicated that the nicotine chewing gum had no significant influence on any of the oral health parameters graded, as compared to the placebo gum. The continuation of smoking, however, was associated with significant increases in gingivitis and calculus rates.

One hundred six edentulous subjects were given nicotine-containing chewing gum to evaluate the ability to chew the gum, to observe the adherence of the gum to denture-base materials, and to evaluate the effect of gum chewing on denture-bearing tissues. Prior to the 13-week study, the denture-bearing ridges and the tissue and polished surfaces of the denture were evaluated clinically and photographed. Questionnaires were used to elicit personal habits of the subjects. Of the 59 subjects completing the study, most could manipulate and chew the gum effectively, three-fourths reported that gum adherence was not a problem, and no adverse reaction to oral tissues was observed.

This study was designed to compare various salivary parameters between smokers and non-smokers and to determine the influence of a nicotine-containing chewing gum (used to aid in quit-smoking efforts) upon these same parameters. At the baseline examination, subjects were assigned to one of three groups: non-smokers who did not utilize any gum, smokers provided a nicotine-containing gum, and smokers provided a placebo gum. Saliva was collected from all subjects and analyzed for acidogenicity and buffer pH as well as for levels of thiocyanate, lactoperoxidase, lysozyme, lactoferrin, and secretory IgA. After 15 weeks of gum usage, saliva was again collected from each subject and the identical analyses performed. Significant differences were observed between smokers and non-smokers with regard to three parameters: The saliva of smokers contained greater concentrations of thiocyanate and lower concentrations of lactoferrin, at the baseline examination and after the 15-week test period. In addition, the CO content of alveolar air was higher in smokers at both examination periods. In contrast, the use of the nicotine gum per se had no effect on any of the test parameters.