Introduction: Nicotine gum, a proven effective aid to cessation, comes in two doses: 2-mg and 4-mg. Assignment to the higher dose has traditionally been based on daily cigarette consumption. This paper evaluates efficacy of the gum when the 4-mg dose is assigned based on time to first cigarette (TTFC) being ≤ 30 min.
Methods: In a secondary analysis of a randomized, double-blind, placebo-controlled trial that allocated smokers randomly to placebo, 2-mg, or 4-mg gum (Garvey, A. J., Kinnunen, T., Nordstrom, B. L., Utman, C. H., Doherty, K., Rosner, B., et al. (2000). Effects of nicotine gum dose by level of nicotine dependence. Nicotine & Tobacco Research, 2, 53-63. doi:10.1080/14622200050011303), we evaluated outcomes when 4-mg gum was given to subjects with TTFC ≤ 30 (n = 158, placebo n = 159).
Results: Active treatment doubled or tripled abstinence rates versus placebo. This also held among smokers with a history of treatment failure. The effect of 4-mg gum was significant among light smokers (<25 CPD) with TTFC ≤ 30; 2-mg gum was not.
Conclusion: This analysis suggests that assigning dose of nicotine gum based on TTFC is an effective and appropriate means of dose allocation.