COMPREHENSIVE CORPORATE SMOKING CESSATION PROGRAM

SMOKING IS THE LEADING PREVENTABLE CAUSE OF DEATH IN THE UNITED STATES. IT IS A MAJOR CAUSE OF CANCER AND OTHER SERIOUS DISEASE, AND IS BY FAR THE LEADING CAUSE OF LUNG CANCER. THE STUDY WILL TEST A STATE-OF-THE-ART CORPORATE SMOKING CESSATION CLINIC SUPPLEMENTED BY EITHER ACTIVE OR PLACEBO NICOTINE REPLACEMENT (TRANSDERMAL NICOTINE SYSTEM). IT IS HYPOTHESIZED THAT ACTIVE NICOTINE REPLACEMENT WILL LEAD TO A SIGNIFICANT REDUCTION IN WITHDRAWAL SYMPTOMS AND TO IMPROVED ABSTINENCE. A MINIMUM OF 120 SUBJECTS FROM SIX COMPANIES WILL BE RANDOMLY ASSIGNED TO EITHER ACTIVE OR PLACEBO TRANSDERMAL PATCH. ALL SUBJECTS WILL ATTEND A 9 WEEK SMOKING CESSATION CLINIC FOLLOWED BY SEVERAL ASSESSMENT SESSIONS. WITHDRAWAL SYMPTOM AND SMOKING STATUS DATA WILL BE COLLECTED AT EACH SESSION. SELF-REPORTED ABSTINENCE WILL BE VALIDATED BY EXPIRED CARBON MONOXIDE AND SALIVA COTININE. TWELVE MONTH OUTCOME DATA WILL BE COLLECTED INDEPENDENTLY OF SBIR FUNDING. IF RESULTS ARE AS HYPOTHESIZED, A WIDELY DISSEMINABLE CORPORATE PROGRAM WILL HAVE BEEN ESTABLISHED THAT FOR THE FIRST TIME SYSTEMATICALLY INTEGRATES PSYCHOLOGICAL AND BEHAVIORAL INTERNVENTION. THIS WILL LEAD DIRECTLY TO PHASE II RESEARCH.