SBIR-STTR Award

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.

Anticipated Results:
Commercial application includes the potential for low-cost mass production and wide-scale distribution of a readily available, over-the-counter smoking-deterrent lozenge for use in minimal intervention self-help smoking cessation or relapse prevention programs, or for use in government/private industry smoking cessation programs.National Heart, Lung, And Blood Institute (NHLBI)

During Phase II, New Life Health Products Corp., will expand its double-blind placebo controlled clinical trial of a 2.5 mg. silver acetate smoking deterrent lozenge to demonstrate safety and efficacy. Five hundred adult male and female smokers, of whom approximately half will be minorities, will be assigned randomly to active lozenge and placebo conditions. Each smoker will receive brief behavioral counseling and self-help material in addition to the lozenge. Expired air carbon monoxide and urine cotinine will serve as objective measures of quitting. The study will assess initial and long-term smoking cessation and will provide data which will be submitted to the U.S. Food and Drug Administration to demonstrate safety and efficacy of the lozenge for men and women, Blacks, Hispanics, and Whites. The research will add to the anti-smoking armamentarium and will yield a self-help smoking cessation product that can assist smokers who continue to expose themselves to the risk of tobacco-related disease in improving their chances for success in quitting.

Thesaurus Terms:
acetate, human therapy evaluation, oral administration, silver, smoking cessation avoidance, behavior modification, clinical study /trial, relapse /recurrence, tobacco abuse, tobacco abuse prevention adult human (21+), carbon monoxide, human clinical subject, nicotine, urinalysis, videotape /videodisc