A comparison of a nicotine sublingual tablet and placebo for smoking cessation.

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.