Abstract
BackgroundDespite access to various pharmacotherapies and counseling support to aid cessation, smokers typically demonstrate quit rates below 50%. This report describes the results of a Phase 2a study exploring the efficacy of a liquid nicotine delivery system as an aid to smoking cessation assessed after 12 weeks of therapy.MethodsA single-arm Phase 2a study was conducted. Community-based smokers (ages 18+ years, smoking at least 10 cigarettes daily for the past year and interested in making a quit attempt) were recruited and completed clinic visits at 2 week intervals over the 12 week study period where carbon monoxide levels were assessed and the Smoke-Break product was rated on taste and overall satisfaction. Participants were provided with a supply of liquid nicotine cigarettes (e.g., Smoke-Break) at each clinic visit. A total of 69 smokers were enrolled and received the intervention product (intention to treat group, ITT) and 52 smokers verified participation (according to protocol group, ATP).ResultsThe cessation rate at 12 weeks after the baseline visit, assessed as the bioverified point prevalence of abstinence, was 71.1% (95% confidence interval [CI] 58.8%-83.5%) in the ATP group and 53.6% (41.8%-65.4%) in the ITT group. Participants rated the liquid nicotine delivery system highly and also expressed general satisfaction. Few adverse events were identified with no serious adverse events.ConclusionsThese results support the efficacy of the liquid nicotine delivery system in smoking cessation. If this nicotine delivery product proves to be effective in larger trials, it could represent an inexpensive, readily accessible and well-tolerated agent to promote smoking cessation.Trial RegistrationThis trial is registered at clinicaltrials.gov as study NCT00715871.
Highlights
Despite access to various pharmacotherapies and counseling support to aid cessation, smokers typically demonstrate quit rates below 50%
While somewhat different definitions for cessation, and variable time intervals were used across these studies, complicating direct comparisons, bupropion and varenicline have greater efficacy, but require an office visit to get a prescription and are generally more costly compared to several formulations of nicotine replacement therapy (NRT) available over the counter
Selected demographic and tobacco use characteristics of study participants are summarized in table 1
Summary
Despite access to various pharmacotherapies and counseling support to aid cessation, smokers typically demonstrate quit rates below 50%. This report describes the results of a Phase 2a study exploring the efficacy of a liquid nicotine delivery system as an aid to smoking cessation assessed after 12 weeks of therapy. The Public Health Service guidelines for treating tobacco use and dependence, last updated in 2008, endorse the use of several proven pharmacotherapies for cessation including nicotine replacement (e.g., patch, lozenge, gum/resin, inhaler, and nasal spray), bupropion (Wellbutrin®/Zyban®) and varenicline (Chantix®), as well as the combination of counseling support and pharmacotherapy [5,6]. Quit rates for nicotine replacement therapy (NRT) range between 20-24%,[7] compared to 30% for bupropion [8] and 44% for varenicline [9,10]. Population efficacy for a smoking cessation product reflects the combination of product effectiveness and population reach
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