Almost 3300 smokers participated in this double-blind, placebo-controlled study. Participants were enrolled in 27 study sites across the US. Participants were allowed to choose between 2-mg and 4-mg doses of nicotine gum, with the higher doses generally being selected by heavier smokers. Within each dose group, participants were then randomized to receive either the active gum or a placebo, yielding 4 approximately equal groups.

The study assessed initial 24-hour abstinence and 28-day abstinence, and participants were followed up at 6 months to determine overall success rates for quitting. The odds of smokers achieving 24-hour abstinence were 40 to 90% higher using active gum compared to placebo, and 2 to 4.7 times higher for attaining 28-day abstinence. At the end of 6 months, while absolute quit rates were somewhat low, the odds of quitting were about 2 to 6 times greater for active gum users as for the placebo users, with a quit rate of 6% in the 4-mg group.

The study also evaluated the safety of using nicotine gum while reducing smoking. The authors report that no unexpected adverse events were observed, even among those who most heavily smoked and used gum, concluding that "Using nicotine gum while smoking carries little to no incremental risk."

Writing in the article, Saul Shiffman, states, "This is the first study to demonstrate that smokers wanting to quit by gradual reduction can substantially increase their success by using nicotine gum to facilitate reduction and cessation. Nicotine gum helped smokers reduce smoking, achieve initial abstinence and maintain abstinence. The advantage of active nicotine replacement therapy (NRT) treatment is particularly evident for heavy smokers treated with the 4-mg nicotine gum, for which treatment increased the odds of quitting for 6 months sixfold. This expands treatment options for the substantial proportion of smokers who prefer quitting gradually, who have relatively low chances of quitting and who have heretofore been implicitly excluded from the use of NRT to help them quit. Offering this new way to use NRT may enhance the appeal and reach of a treatment that increases success, and thereby have positive public health impact. Given the ongoing extraordinary health toll from smoking, consideration should be given to novel approaches that increase success in quitting."

Paper: The article is "Quitting by Gradual Smoking Reduction Using Nicotine Gum: A Randomized Controlled Trial" by Saul Shiffman, PhD, Stuart G. Ferguson, PhD, and Kenneth R. Strahs, PhD. It appears in the American Journal of Preventive Medicine, Volume 36, Issue 2 (February 2009) published by Elsevier.

Source: Elsevier Health Sciences