The overall goal of this project is to develop a self-help adjuvant behavioral treatment for use in conjunction with the transdermal nicotine patch (TNP) for smoking cessation. The program will be composed of two components: a credit-card sized hand-held computer and a behavioral treatment guide. The computer will be used to structure a scheduled smoking regimen that will prepare users for initiation of nicotine replacement therapy with the TNP. The treatment guide will contain instructions for use of the computer, information on the appropriate use of TNP, and a series of chapters covering standard behavioral strategies to facilitate smoking cessation and relapse prevention. This Phase I project will include development of a first generation prototype system and a 12-week feasibility study with 90 smokers. Smokers will be randomly assigned to one of two conditions: TNP with scheduled smoking or standard TNP (with a behavioral treatment manual). Criteria for feasibility will be statistically significant differences between groups on latency to smoking relapse; smoking and nicotine intake during the pre-patch phase; degree of withdrawal symptoms, urges to smoke, and use of behavioral coping strategies; and significant within treatment changes in cotinine levels and adherence to the smoking schedule among subjects in the computer scheduled group. Data from the trial and feedback from subjects will be used to guide further product development. During Phase II, a second generation prototype will be developed and evaluated in a large-scale clinical trial.
Each year, up to one-third of the nearly 50 million smokers in the U.S. try to quit smoking. Use of the transdermal nicotine patch is an extremely popular method for attempting cessation; to date, well over 4 million Americans have used nicotine patches. An adjuvant behavioral intervention that serves as an effective complement to the transdermal patch could have broad commercial appeal and a significant public health impact.
