Clinical Evaluation of an Otc Smoking Deterrent Lozenge

Period of Performance: 08/22/1991 - 07/31/1992

Unknown

Phase 2 SBIR

Recipient Firm

NEW Life Health Products Corporation
Millbrook, NJ 07869
Principal Investigator

Abstract

DESCRIPTION (adapted from the investigator's abstract) 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.