Safety and Effectiveness of Nicotine Chewing Gum for Smoking Cessation in USAF Aviators

摘要

A double blind randomized placebo controlled trial of 2 mg nicotine chewing gum is proposed to test its safety and effectiveness for smoking cessation in USAF flying personnel. Subjects are USAF flyers who desire to quit smoking. The study has two parts: a side effects study which employs a third no-gum group as an additional control and an effectiveness study which evaluates the gum's efficacy in typical aeromedical clinic use. Mean severity and frequency of 16 side effects will be measured in the three groups by a questionaire during the first two weeks of therapy. The nicotine gum group's mean symptoms will be compared to the other groups by the Wilcoxon Rank Sum Test. Subjects in the nicotine and placebo gum groups will be followed for one year for smoking cessation with confirmation by blood COHb levels. A relative effectiveness ratio of the gum will be obtained. This study should provide meaningful information concerning the level of side effects which has previously not been well quantified, but which is critical to the drug's aeromedical use. Results of the study will provide the basis for USAF aeromedical policy formulation regarding nicotine gum as a method of smoking intervention. (Thesis)