Pharmacologic Intervention for Postcessation Weight Gain
To test pharmacologic intervention for smoking postcessation weight gain using nicotine gum and phenylpropanolamine (PPA).
|Study Design:||Observational Model: Natural History|
|Study Start Date:||July 1991|
|Estimated Study Completion Date:||June 1997|
Despite the potential importance of weight gain to smoking relapse, in 1991 there had been virtually no success in eliminating, or even reducing, the weight gain following smoking cessation. Two promising pharmacologic methods for reducing postcessation weight gain were nicotine gum and an over-the-counter drug, phenylpropanolamine gum ([PPA]. However, the relative efficacy of these two drugs had never been evaluated and the mechanisms of action of both drugs on weight gain were unknown.
The investigators determined the efficacy of nicotine gum and phenylpropanolamine (PPA) gum relative to a placebo in the reduction of postcessation weight gain throughout a 13-week combined behavioral and pharmacologic treatment program. Following cessation of the drugs at the end of treatment, they monitored long-term effects of these drugs on body weight at both a 6- and a 12-month follow-up. They also determined the mechanism of action of both nicotine gum and PPA gum (viz., changes in dietary intake, physical activity, or metabolic rate) on change in weight during the course of treatment and evaluated withdrawal symptoms of smoking cessation as they were moderated by either nicotine gum or PPA gum use during the course of treatment. Finally, they investigated whether PPA and nicotine gum produced an incremental effect on smoking cessation (relative to placebo gum) in a sample of female smokers who were at high risk for postcessation weight gain at posttest and at a 6- and 12-month follow-up.