Dose effects of nicotine gum.

Nicotine gum has been shown to be effective in improving abstinence rates, and in reducing post-cessation withdrawal distress and weight gain. However, the dose effects of nicotine gum on these outcomes is not known. In the present study, we varied the amount of 2 mg nicotine gum prescribed to motivated quitters to explore the hypotheses (a) that motivated quitters would use more pieces of gum when coached and counseled to do so and (b) that there would be a dose-related effect of gum use on abstinence, withdrawal symptoms, and weight gain. One hundred seventy-seven volunteers were assigned to chew either 0, 7, 15, or 30, pieces per day of 2 mg nicotine gum. Biological verification of gum use and smoking abstinence were assessed in community volunteers who attended an intensive behavioral counseling program for smoking cessation while using nicotine gum for 3 months. In the survival analysis at 12 weeks, gum-group assignment was not related to successful abstinence. In the subset of 42 abstinent subjects, there was a strong positive relationship between pieces per day of nicotine gum used and saliva cotinine. However, there was substantial variability in groups of subjects reporting similar amounts of gum use. Withdrawal symptom reporting was not related to either gum use or cotinine levels. Weight gain was significantly related in a dose-dependent manner to salivary cotinine levels, but not to gum group assignment, with high and low cotinine subjects gaining on average, 4.0 and 6.6 pounds, respectively. Discussion of the use of high levels of nicotine gum is addressed. Consistent with earlier work, the study provided further support for the relationship between nicotine replacement level and post-cessation weight gain.

RCT Entities:   Population Interventions Outcomes