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This study assessed the efficacy and safety of a nicotine sublingual tablet in smoking cessation in a randomized, double-blind, placebo-controlled outpatient trial conducted between January 1996 and May 1997. Two hundred and forty-one adult smokers (> or = 10 cigarettes/day for at least 3 years) used nicotine 2-mg sublingual tablet (n = 120) or placebo (n = 121) for up to 6 months (a 3-month treatment period followed by a 3-month tapering period). Subjects who scored <7 on the Fagerström Tolerance Questionnaire used 1 tablet/h (up to maximum of 20/day), whereas subjects who scored (7 used 2 tablets/h (up to maximum of 40/day). Brief counseling was provided at baseline and at all visits. Self-reported abstinence was measured from week 2 onwards, confirmed by expired carbon monoxide (CO) levels <10 ppm at each visit (1, 2, 3 and 6 weeks and 3, 6 and 12 months). After 6 weeks of treatment, CO-validated abstinence rates were 48% in the active group and 23% in the placebo group (p < 0.0001). At the 3-, 6- and 12-month visits, abstinence rates (active vs. placebo) were 33% vs. 17% (p = 0.0046), 21% vs. 11% (p = 0.0304) and 18% vs. 10% (p = 0.0606). Adverse events were mild and transient and reflected those reported with existing nicotine replacement formulations. We concluded that the nicotine 2-mg sublingual tablet was effective as a smoking cessation aid.

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In vitro responsiveness of spleen cells from NZB/NZW (B/W) female mice, aged 2 through 40 weeks, to the mitogens phytohemagglutinin (PHA), concanavalin-A (Con-A) and lipopolysaccharide (LPS) was determined. An age-related decline in proliferative response of splenic cells was found; this decline correlated with the age of onset and progression of lymphoid infiltration in lacrimal and salivary glands in the mice. The worsening with age of this lymphoid infiltrate, coupled with the decline in responsiveness to mitogens, suggests a complex immunopathologic process with destruction of glands terminating in a disease similar to the Sjogren syndrome in humans.