A placebo-controlled randomized trial of the effects of PPA and nicotine gum on cessation rates and post-cessation weight gain in women

This study assessed the efficacy of two forms of pharmacotherapy (nicotine gum and phenylpropanolamine (PPA) gum) in addition to a 13-week cognitive behavioral smoking cessation program targeted for women. Participants were 439 females who met rigorous screening criteria and were randomized to one of the three treatment intervention groups (PPA gum, nicotine gum, or placebo gum). All subjects attended a 13-week cognitive behavioral smoking cessation program and were given specific instructions on gum chewing. At posttest, and 6- and 12-month follow-ups, body weight and point prevalence abstinence (quit smoking status at the time of measurement) were assessed. Analyses to determine potential differences between treatment groups on weight change and cessation rates were performed. Results indicated that neither change in body weight nor cessation rates significantly differed between groups. Attendance to sessions did appear to consistently increase the likelihood of quitting smoking at posttest and at each of the follow-ups. These results suggest that although the pharmacological interventions had no effect on cessation rates and postcessation weight gain, the behavioral component of the intervention was effective in increasing the odds of quitting smoking in women. Future efforts should focus on increasing adherence to session attendance.