COMBINING SCHEDULED REDUCTION WITH NICOTINE REPLACEMENT

描述：该二期项目的总体目标是开发

DESCRIPTION: The overall goal of this Phase II project is to develop an easily administered behavioral program to serve as a companion to the use of the nicotine patch for smoking cessation. The program, LifeSign for the Nicotine Patch (LS-NP), will consist of a credit card size computer and a program guide. The computer will work by altering smoking habits prior to use of the nicotine patch. The computer will assess baseline smoking patterns, prompt users to smoke at fixed intervals, and then gradually increase intervals between cigarettes, thereby reducing smoking. The goal of the computerized smoking schedule is twofold: decrease nicotine intake and disrupt conditioned smoking patterns prior to using the nicotine patch. The product will be suitable as either a self-help program or for use in clinical treatment settings. During Phase I, a prototype system was developed and tested in clinical study with 94 subjects. Promising results were obtained demonstrating the feasibility of the product concept. During Phase II, a second generation system will be developed, and a randomized clinical outcome study with six-month follow-up will be conducted to evaluate the product. Smokers will be randomly assigned to one of two conditions: patch plus LS-NP or patch alone. Data on smoking, patch use, withdrawal symptoms, compliance with the computerized program, and ratings of satisfaction and usability will be collected. Following completion of the trial, plans will be formulated for a version of the product appropriate for commercial release. PROPOSED COMMERCIAL APPLICATION: This product should have broad commercial appeal among the nearly one quarter of the U.S. adult population that smokes. Sales of nicotine patches have increased dramatically since it was approved by the FDA for over the counter sales. As a treatment adjunct for the use of the nicotine patch, this product should have both significant commercial viability and a positive public health impact.