CLINICAL EVALUATION OF AN OTC SMOKING DETERRENT LOZENGE

THE OBJECTIVE OF THIS STUDY IS TO INVESTIGATE THE FEASIBILITY AND EFFECTIVENESS OF A NEWLY DEVELOPED 2.5-MG SILVER-ACETATE-BASED SMOKING-DETERRENT LOZENGE (PATENT PENDING) AS AN AID TO IMPROVING SMOKING CESSATION RATES AND IN PREVENTING RELAPSE. PUBLISHED STUDIES ON THE USE OF A 6-MG SILVER-ACETATE-BASED GUM SUGGEST SIGNIFICANT INCREASES IN SMOKING CESSATION RATES, BUT FURTHER OBJECTIVE CLINICAL EVALUATION IS NEEDED. INDEPENDENT EVALUATION IN A HOME USE TEST AND A PHYSICIAN FOCUS GROUP SUGGESTED IMPORTANT LOZENGE ADVANTAGES OVER THE GUM: LONGER DETERRENT EFFECTIVENESS AT LOWER LEVELS OF ACTIVE INGREDIENT, IMPROVED SAFETY, LOWER COST, AND LONGER OPPORTUNITY FOR USING THE PRODUCT TO PREVENT RELAPSE. THE OBJECTIVE OF PHASE I IS TO INVESTIGATE THE FEASIBILITY AND EFFECTIVENESS OF THE LOZENGE FOR USE IN MINIMAL SMOKING CESSATION INTERVENTIONS AND BEHAVIORAL RELAPSE PREVENTION PROGRAMS. PHASE II WILL EXTEND THE STUDY TO INCLUDE LARGER SAMPLE SIZE, LONGER FOLLOWUP, AND OTHER SETTINGS (E.G., PHYSICIAN OFFICES). RESULTS OF THE CLINICAL EVALUATIONS WILL BE PUBLISHED, AND INDUSTRY AND GOVERNMENTAL PARTNERSHIPS WILL BE SOUGHT TO COMMERCIALIZE AND DISTRIBUTE THE LOZENGE.