A pilot study of mailed nicotine lozenges with assisted self-help for the treatment of smokeless tobacco users.

Smokeless tobacco (ST) is associated with adverse health consequences yet treatment resources for ST are not widely available. Cost-effective behavioral interventions incorporating self-help materials and counseling calls have been demonstrated to reduce ST use rates and can be easily disseminated, but the feasibility and effectiveness of incorporating pharmacotherapy into this approach have not been evaluated. We conducted a clinical pilot study randomizing 60 patients to 12 weeks of the 4-mg nicotine lozenge or placebo delivered through the mail. All subjects received an assisted self-help intervention (ASH) with telephone support. At the end of the medication phase, lozenges were being used by 63% of subjects in the 4-mg nicotine lozenge group and 43% in placebo. The nicotine lozenge decreased composite withdrawal symptoms and adverse events were minimal. No significant differences were observed in abstinence rates between the two groups at 3 or 6 months. We conclude that the mailing of nicotine lozenges to ST users is a feasible and safe strategy the efficacy of which needs to be evaluated.