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.
| Hymowitz, N; Jackson, J; Carter, R et al. (1996) Past quit smoking assistance and doctors' advice for white and African-American smokers. J Natl Med Assoc 88:249-52 |
| Hymowitz, N; Eckholdt, H (1996) Effects of a 2.5-mg silver acetate lozenge on initial and long-term smoking cessation. Prev Med 25:537-46 |
