Abstract
IntroductionNicotine replacement medications are moderately effective in increasing quit rates. However, some smokers reject such aids, suggesting the value of considering alternative options. Snus, a smokeless tobacco product with low nitrosamine content, could offer an alternative. This study compared smoking cessation rates for snus, with and without information about reduced risk relative to smoking, with a nicotine lozenge (without relative risk information).MethodsA randomized, open-label, multicenter clinical trial was performed with 649 smokers, aged 21 to 65, who smoked at least 10 cigarettes per day for the past year and who were motivated to quit smoking. Participants were followed for up to 12 months and were provided no counseling or support. Smoking cessation was analyzed as continuous smoking abstinence (no smoking following quit date) and repeated point prevalence abstinence (no smoking within past 7 days).ResultsAbstinence rates did not differ significantly between snus and the nicotine lozenge—continuous abstinence did not differ at any time point, and point prevalence rates differed only at month 3, when the lozenge group showed higher abstinence rates (17.4%) than either of the two snus groups (snus alone: 8.7%; snus plus information: 10.1%). Large percentages of participants used the products during the treatment period. Providing relative risk information to snus users did not affect snus use. The amount of use did not predict subsequent outcome. Adverse events were reported at similar rates across the three groups.ConclusionsSmoking cessation rates were comparable between snus and a nicotine lozenge, but success rates in this trial were low.ImplicationsThis randomized trial of the nicotine lozenge, snus, or snus plus information on the relative risks of smokeless tobacco versus smoking found comparable but low smoking cessation rates for all three groups at weeks 12, 26, and 52. The one-time provision of relative risk information did not lead to greater snus use among those provided the information, suggesting no effect for this brief intervention.
Highlights
Nicotine replacement medications are moderately effective in increasing quit rates
Abstinence rates did not differ significantly between snus and the nicotine lozenge—continuous abstinence did not differ at any time point, and point prevalence rates differed only at month 3, when the lozenge group showed higher abstinence rates (17.4%) than either of the two snus groups
Two-thirds (433/649 [66.7%]) discontinued the study; few withdrew due to adverse events (AEs) (n = 19) or protocol violations (n = 11)
Summary
Nicotine replacement medications are moderately effective in increasing quit rates. some smokers reject such aids, suggesting the value of considering alternative options. Implications: This randomized trial of the nicotine lozenge, snus, or snus plus information on the relative risks of smokeless tobacco versus smoking found comparable but low smoking cessation rates for all three groups at weeks 12, 26, and 52. Quit attempts by US smokers have been increasing in recent years,[1,2] yet overall rates of smoking cessation are low, despite the availability of effective pharmacological treatments, including nicotine replacement therapies (NRT), which have been available over-the-counter for 20 years.[3] most quit attempts proceed without pharmacological assistance,[4] and many smokers reject NRT.[5,6]. Multiple forms of NRT are available, all sharing the strategy of providing nicotine, without the toxins in cigarette smoke, to facilitate transition to abstinence This suggests that noncombusted tobacco products could provide a similar benefit. Smokeless tobacco (SLT) products are significantly less hazardous than smoking.[7,8] Snus, a type of smokeless tobacco with low levels of tobacco-specific nitrosamines,[9] has low risk.[10,11]
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