Obesity Clinical Trial
To test pharmacologic intervention for smoking postcessation weight gain using nicotine gum and phenylpropanolamine (PPA).
BACKGROUND:
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.
DESIGN NARRATIVE:
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.
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