Transdermal nicotine has been recently approved for OTC use and now provides millions of smokers with access to an effective form of nicotine replacement. Evidence from a variety of studies (i.e., Fiore, et. al., 1996), suggests that cessation efficacy may be enhanced by combining the patch with behavioral interventions aimed at improving the smoker's coping skills and urge resistance. Thus, there is a need to develop new treatments, which are compatible with the self-help focus of OTC patch treatment, and have the potential to produce sustainable changes in such behavior. Recent developments in behavioral and computer technology suggest that """"""""scheduled smoking"""""""" (smoking at designated times prior to quitting), may be well suited for this purpose. Relative to traditional gradual or abrupt quitting, scheduled smoking results in higher rates of long-term abstinence, coping behavior, and self-efficacy, and lowered levels of negative affect. Moreover, use of small a programmable computer to administer the intervention, may improve patient acceptability and deliver schedules uniquely tailored to the individual's smoking pattern. A total 675 smokers from the Houston community will be randomly assigned to 3 groups: Scheduled Smoking (SS), Nicotine Patch (NP), and Scheduled Smoking plus Nicotine Patch (SSNP). Each participant will receive a self-help Tip Guide & Calendar. The guide contains basic cessation advice common to all groups, as well as instructions specific to the use of scheduled smoking, nicotine replacement, or their combination. During a one-week baseline, all participants will monitor their smoking using the """"""""PalmPilot"""""""", Personal Digital Assistant (PDA). The PDA will automatically record the date and time of all cigarettes smoked. Over the next three weeks, NP participants will continue to monitor smoking, while Scheduled Smoking (SS) and Scheduled Smoking plus Nicotine Patch (SSNP) participants, are prompted to smoke at specific times of the day by the PDA. The program gradually increases the interval between prompted cigarettes, using an algorithm based on baseline smoking frequency and time awake. On the quit-date, both smokers in the NP and SSNP conditions will begin 6 weeks of transdermal nicotine replacement. The NP group will receive 3 weeks of nicotine replacement at 21mg/day; 2 weeks at 14mg/day, and one week at 7mg/day. The SSNP group will begin NRT at a dose commensurate with the degree of reduction achieved by scheduled smoking. Most smokers will start at 7mg/day. All participants will also receive regularly scheduled postcards, which highlight cessation tips selected from the guide. We hypothesize that smokers receiving the combined treatment (SSNP) will be abstinent more often, and show greater changes in coping and other behaviors, than smokers in either the SS or NP groups.
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