R.J. Reynolds conducted a multicenter clinical trial to compare smoking cessation rates when healthy smokers with an intent to quit were switched to Camel SNUS or a nicotine lozenge. The effect of providing one-time smokeless tobacco relative risk information to subjects assigned to SNUS was also examined.

The study consisted of three cohorts: SNUS with one-time smokeless tobacco relative risk information; SNUS without smokeless tobacco relative risk information; and Nicorette Lozenge. The study was powered to detect a difference of 14.5% (OR of 0.57) for an average abstinence of 50% between two cohorts with a sample size of 200 subjects per cohort. This powering allowed detection of smaller differences in cessation rates if the true abstinence rate was different than 50%.

Following enrollment, subjects were randomized to a cohort and provided with either SNUS or Nicorette lozenges for a 12 week period. The subjects were followed for up to 12 months beyond their target cessation date. Study subjects periodically answered questionnaires on their use of cigarettes and study product.

Four different criteria, based upon SRNT working group recommendations, were used to evaluate cessation. Criteria evaluated included: prolonged smoking abstinence; repeated point prevalence smoking abstinence; and two measures of continuous smoking abstinence. Abstinence was confirmed by measurement of exhaled CO and blood cotinine levels.

A description of the study design, study endpoints, and cohort demographics will be provided in this presentation.