OBJECTIVE: Examine weight change in subjects receiving variable doses of transdermal nicotine replacement for smoking cessation.
DESIGN:Randomized, double-blind clinical trial.
SETTING:One-week inpatient treatment with outpatient follow-up through 1 year.
INTERVENTION:This report examines weight change after smoking cessation for 70 subjects randomized to placebo or to 11, 22, or 44 mg/d doses of transdermal nicotine. The study included 1 week of intensive inpatient treatment for nicotine dependence with active patch therapy continuing for another 7 weeks. Counseling sessions were provided weekly for the 8 weeks of patch therapy and with long-term follow-up visits at 3, 6, 9, and 12 months.
MEASUREMENTS AND MAIN RESULTS:Forty-two subjects were confirmed biochemically (i.e., by expired carbon monoxide) to be nonsmokers at all weekly visits during patch therapy. any studies have demonstrated that, for most smokers, cessation of smoking is accompanied by weight gain. 1 The acceptance of this consequence of smoking cessation is widespread, and many smokers report fear of weight gain as a reason for continuing to smoke or for their relapse to smoking after achieving abstinence. [2][3][4] Although there is little direct evidence that postcessation weight gain is a serious cause of smoking relapse, 5 the fact that fear of weight gain is a potential barrier to the initiation of cessation attempts makes the development of methods to control postcessation weight gain an important area of research for the treatment of nicotine dependence.Postcessation weight gain is most likely influenced by changes in energy balance (caloric expenditure vs intake) that occur with smoking cessation. Klesges and coworkers have proposed a working model conceptualized as multiple variables moderating the energy balance equation, which in turn affects weight change. 1 An extensive discussion of potential biological and psychological mechanisms relevant to the relation between smoking, body weight, and energy balance can be found in the report of the task force from the National Working Conference on Smoking and Body Weight. 6 Finally, Perkins has proposed the possibility that modest weight gain after smoking cessation is largely unavoidable for most smokers because the intake of nicotine associated with smoking maintains an artificially reduced weight by increasing energy expenditure and thereby altering the regulation of body weight around a lower set point. 5,7 Cessation removes this influence on energy expenditure, allowing body weight to return to "normal."If nicotine is an important variable influencing the energy balance equation, or the body weight set point, then nicotine replacement therapy should help control postcessation weight gain. Some studies involving nicotine gum have reported no difference in weight change associated with the use of gum during smoking cessation [8][9][10][11] ; however, several studies report a significant weight-suppressing effect associated with gum use. [12][13][14][15][16][17][18] Similarly, a recent stu...