Unfortunately, little data exist to link use of smokeless STI 571 PREPs with smoking behavior and quitting. Several analyses of Swedish smokers, in whom use of smokeless tobacco is prominent, suggest that self-selected use of smokeless tobacco is associated with increased cessation (Furberg et al., 2005, 2007; Gilljam & Galanti, 2003). A better test of the influence of PREPs on smoking and cessation would be through randomized clinical trials, but few such studies exist (Hatsukami et al., 2008). In a recent study on Danish smokers (Tonnesen, Mikkelsen, & Bremann, 2008), 263 smokers were randomized to receive cessation counseling and/or smokeless tobacco. Smokers using smokeless tobacco, relative to control participants, were almost twice as likely to achieve end-of-treatment continuous abstinence.

Although abstinence outcomes at other timepoints were nonsignificant, they were all numerically higher in the smokeless group, which argues against an undermining effect. Collectively, these studies suggest that newer smokeless tobacco products might help smokers succeed in their efforts to quit. A particularly compelling question is how smokeless tobacco might influence smoking behavior and cessation among smokers who are not interested in quitting, for whom novel methods for cessation induction are necessary. To date, there has never been a randomized clinical trial, among unmotivated smokers, testing smokeless tobacco use and its influence on smoking behavior and cessation. This article presents a pilot randomized trial testing Ariva and Stonewall, two products that are conceptually equivalent (both smokeless and spitless tobacco lozenges), versus conventional cigarettes.

Methods Participants Participants were recruited through local media advertising and flyers, using the general message ��smokers needed to test new and potentially safer tobacco product.�� Participants were eligible for study entry if they (a) were aged 18�C65 years, (b) were daily smokers of at least 10 cigarettes/day on average for at least 1 year, (c) AV-951 had no recent history of cardiovascular distress (heart attack in past year; arrhythmia, uncontrolled hypertension), (d) were neither pregnant nor breast feeding, (e) had no intention to quit smoking in the next month (��7 on a 0�C10 scale), (f) had no use of non-cigarette tobacco (cigars, chewing tobacco) in the past 6 months, (g) had lifetime nonuse of any PREP, and (h) had an absence of any major current psychiatric impairment, including current alcohol/drug abuse and dependence. Procedures Within the baseline visit, eligible participants were told of the study purpose: to measure changes in smoking behavior while using the new tobacco product.