The Impact of Three Alternate Nicotine-Delivery Products on Combusted Cigarette Use: A Randomized Controlled Trial.

INTRODUCTION: Smoking cessation is a critical public health goal. This study examined the ability of e-cigarettes and very low nicotine cigarettes (VLNCs) to serve as cigarette substitutes and whether a substitution was supported by steady-state nicotine from a nicotine patch. AIMS AND METHODS: This mixed design experiment with study product (between-subjects) and patch (within-subjects) factors recruited adults smoking cigarettes daily and not motivated to quit (N = 160). Participants were randomized to 4 weeks of: (1) VLNCs; (2) e-cigarettes; or (3) no product. During two switch weeks, one with an active nicotine patch and one with a placebo patch (in a double-blind and counterbalanced fashion), participants were told to not smoke their usual cigarettes. RESULTS: During the switch weeks, participants in the VLNC (M = 2.88, SD = .65) and e-cigarette (M = 3.20, SD = .63) groups smoked fewer of their own cigarettes per day than did no product group participants who continued to smoke their own cigarettes (M = 5.48, SD = .63); the VLNC and e-cigarette groups did not differ. There was no main effect of patch on mean usual brand cigarettes smoked per day (P = .09), nor was there a product × patch interaction (P = .51). There was a product × age interaction (P = .03); smokers aged 60-74 smoked more of their own cigarettes if they were randomized to no product group. CONCLUSIONS: VLNCs and e-cigarettes appear to reduce usual brand cigarettes smoked per day to a similar degree, regardless of patch condition. Behavioral factors, in addition to nicotine dependence, play an important role in sustaining smoking behavior and need to be addressed in smoking cessation treatment. IMPLICATIONS: This study found that behavioral substitutes for cigarettes, whether or not they delivered nicotine, reduced the number of usual brand cigarettes smoked. Specifically, both e-cigarettes delivering nicotine and VLNCs equally reduce usual brand cigarettes smoked among adults who smoke daily and do not want to quit.

Understanding contexts of smoking and vaping among dual users: analysis of ecological momentary assessment data.

AIMS: To understand dual users' cigarette and e-cigarette use patterns, including the contexts in which they vape versus smoke and to understand how environmental and internal contexts and smoking patterns differ between dual users and exclusive smokers. DESIGN: Longitudinal observational trial. SETTING: Research center in Wisconsin, USA. PARTICIPANTS: Adult dual users (n = 162) and adults who exclusively smoked (n = 143), with no plans to quit smoking or vaping in the next 30 days. MEASUREMENTS: Participants carried smartphones for 2 weeks at baseline to record each use event for the two products and report on the context of their product use. The percentage of mornings where participants vaped first versus smoked were used to compute e-cigarette dependence. FINDINGS: Hierarchical linear regression models with random slopes and intercepts examined the within- and between-subject effects of context on the likelihood of vaping (versus smoking); significant fixed effects were tested for moderation by e-cigarette dependence. Dual users reported significantly more puffs/cigarette [mean = 13.1, standard deviation (SD) = 10.2] than puffs/vape event (mean = 11.7, SD = 11.5; P = 0.01). E-cigarette dependence moderated the influence of social cues (t-ratio = 2.4, P = 0.02) and smoking restrictions (t-ratio = 3.1, P = 0.003) on the likelihood of vaping versus smoking [odds ratio (OR) = 2.30, P = 0.02]. Context was more related to which product was used in those of low versus higher e-cigarette dependence. Reports of strong cravings to smoke and positive expectancies for cigarettes were associated with a reduced likelihood of vaping, whereas strong cravings to vape and positive vaping expectancies were related to increased likelihood of vaping. CONCLUSIONS: Among dual users of cigarettes and e-cigarettes with no motivation to quit, vaping appears to be related to internal cues and more highly linked with social contexts and smoking restrictions (i.e. under stronger external stimulus control) among those with low to moderate e-cigarette dependence compared with high e-cigarette dependence. These findings illustrate the importance of contextual factors in tobacco product use among dual users with the influence of context being reduced at high levels of e-cigarette dependence.

Engaging Smokeless Tobacco Users in Population-Based Cessation Services: Findings From an Observational Study.

Although telephone quitlines are effective for helping smokeless tobacco (ST) users quit, ST users are underrepresented among quitline participants. After ClearWay MinnesotaSM implemented multiple changes to its quitline service (QUITPLAN® Services), utilization increased dramatically, including by ST users. We examined data from Minnesota and Wisconsin to determine whether these changes were unique to Minnesota. Four years of quitline registration data were analyzed for both states. A significant increase in enrollees reporting any ST use was seen in Minnesota after changes were made to services; no change was seen in Wisconsin. A 2-week starter kit of nicotine replacement therapy and the ability to register for services online were popular among Minnesotans reporting ST use. This study suggests that quitline services can be designed to increase participation by ST users.

Dual Users Compared to Smokers: Demographics, Dependence, and Biomarkers.

INTRODUCTION: The availability of electronic cigarettes (e-cigarettes) has profoundly changed the tobacco product landscape. In the United States, almost 6 million adults use both combustible and e-cigarettes (ie, dual users). The goal of this study was to understand how smokers and dual users differ in terms of demographics, cigarette dependence, and exposure to carcinogens. METHODS: An observational cohort (smokers, n = 166, ≥5 cigarettes/day for 6 months and no e-cigarette use in 3 months; dual users, n = 256, smoked daily for 3 months and used e-cigarettes at least once/week for the past 3 months) completed baseline assessments of demographics, tobacco use, and dependence. They also provided breath samples for carbon monoxide (CO) assay and urine samples for cotinine, 3-hydroxycotinine, and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) assays. RESULTS: Compared to smokers, dual users (mean e-cigarette use = 5.5 days/week [SD = 1.9]) were significantly younger and more likely to be white, have more education, report a history of psychiatric co-morbidity, and smoke fewer cigarettes per day. There were no differences in CO, cotinine, or 3-hydroxycotinine levels; however, dual users had significantly lower levels of NNAL than did smokers. Most smokers and dual users had no plans to quit smoking within the next year; 91% of dual users planned to continue using e-cigarettes for at least the next year. CONCLUSIONS: In this community sample, dual users are supplementing their smoking with e-cigarette use. Dual users, versus smokers, smoked fewer cigarettes per day and delayed their first cigarette of the day, but did not differ in quitting intentions. IMPLICATIONS: This comparison of a community sample of established dual users and exclusive smokers addresses key questions of dependence and health risks of dual use in real-world settings. Dual users were more likely to be white, younger, have more than a high school education and have a psychiatric history. Dual users also smoked significantly fewer cigarettes and had lower levels of NNAL (a carcinogen), but they did not differ from exclusive smokers in CO or cotinine levels, suggesting that they supplemented their nicotine intake via e-cigarettes.

A randomized controlled trial of financial incentives to low income pregnant women to engage in smoking cessation treatment: Effects on post-birth abstinence.

OBJECTIVE: Evaluate the effectiveness of monetary incentives for increasing engagement in smoking cessation treatment and improving 6-month abstinence in low-income pregnant smokers. METHOD: Two-group randomized clinical trial recruiting low-income (Medicaid-registered) pregnant smokers receiving assistance through a perinatal support program. Participants were randomized to either an incentive (n = 505) or control condition (n = 509). All participants were offered identical smoking cessation counseling at contacts. Incentive condition participants received incentives for attending pre- and postbirth treatment contacts: $25 for each of 6 prebirth provider visits, $25-40 for each of 4 postbirth home visits at Weeks 1, 2, 4, and 6 (total = $130), $20 for each of 5 postbirth counseling calls and $40 for biochemically verified abstinence at the Week 1 and 6-month visits. Control condition participants received only $40 for attendance at the Week 1 and 6-month postbirth visits ($40 each). MAIN OUTCOMES: Primary outcome was biochemically confirmed 7-day point-prevalence abstinence at 6-month postbirth follow-up. Secondary outcomes included number of home visits and phone calls taken over the first 6 months postbirth; biochemically confirmed abstinence at postbirth Week 1 visit; and self-reported smoking status at 2- and 4-month visits. RESULTS: Incentive condition participants had a higher biochemically confirmed abstinence rate at 6-month postbirth than controls (14.7% vs. 9.2%, respectively: p < .01). This effect was mediated by incentive condition participants' greater acceptance of postbirth home visits and counseling calls. CONCLUSIONS: Moderate incentive payments for smoking treatment engagement (a mean of ≈$214 paid) increased low-income pregnant smokers' engagement and success in smoking cessation treatment. (PsycINFO Database Record

A Randomized Trial of Incentives for Smoking Treatment in Medicaid Members.

INTRODUCTION: Low-income populations are especially likely to smoke and have difficulty quitting. This study evaluated a monetary incentive intended to increase smoking treatment engagement and abstinence among Medicaid recipients who smoke. STUDY DESIGN: Two-group randomized clinical trial of Incentive (n=948) and Control interventions (n=952) for smoking. SETTING/PARTICIPANTS: Medicaid recipients recruited from primary care patients (n=920) and callers to the Wisconsin Tobacco Quit Line (n=980). INTERVENTION: Participants were offered five quitline cessation calls and were encouraged to obtain cessation medication (covered by Medicaid). All participants received payment for completing a baseline assessment and a 6-month smoking test. Only Incentive condition participants received compensation for taking counseling calls ($30 per call) and for biochemically verified abstinence at the 6-month visit ($40). MAIN OUTCOME MEASURES: Seven-day point-prevalence smoking abstinence 6-months post study entry and cost/quit. RESULTS: Incentive condition participants had significantly higher biochemically determined 7-day point-prevalence smoking abstinence rates 6 months after study induction than did Controls (21.6% vs 13.8%, respectively, p<0.0001). A positive treatment effect of incentives was present across other abstinence indices, but the size of effects and levels of abstinence varied considerably across indices. Incentive condition participants were also significantly more likely than non-incentivized Control participants to accept Wisconsin Tobacco Quit Line treatment calls and their acceptance of calls mediated their attainment of higher abstinence rates at 6-month follow-up. The cost/quit/participant averaged $4,268.26 for the Control participants and $3,601.37 for the Incentive participants. CONCLUSIONS: This study shows that fairly moderate levels of incentive payments for treatment engagement and abstinence (a total possible payment of $190) increased very low-income smokers' engagement and success in smoking cessation treatment. CLINICAL REGISTRATION: This study is registered at www.clinicaltrials.gov: NCT02713594.

Enhancing tobacco quitline effectiveness: identifying a superior pharmacotherapy adjuvant.

INTRODUCTION: Telephone tobacco quitlines are effective and are widely used, with more than 500,000 U.S. callers in 2010. This study investigated the clinical effectiveness and cost-effectiveness of 3 different quitline enhancements: combination nicotine replacement therapy (NRT), longer duration of NRT, and counseling to increase NRT adherence. METHODS: In this study, 987 quitline callers were randomized to a combination of quitline treatments in a 2 × 2 × 2 factorial design: NRT duration (2 vs. 6 weeks), NRT type (nicotine patch only vs. patch plus nicotine gum), and standard 4-call counseling (SC) versus SC plus medication adherence counseling (MAC). The primary outcome was 7-day point-prevalence abstinence (PPA) at 6 months postquit in intention-to-treat (ITT) analyses. RESULTS: Combination NRT for 6 weeks yielded the highest 6-month PPA rate (51.6%) compared with 2 weeks of nicotine patch (38.4%), odds ratios [OR] = 1.71 (95% confidence interval [CI]:1.20-2.45). A similar result was found for 2 weeks of combination NRT (48.2%), OR = 1.49 (95% CI: 1.04-2.14) but not for 6 weeks of nicotine patch alone (46.2%), OR = 1.38 (95% CI: 0.96-1.97). The MAC intervention effect was nonsignificant. Cost analyses showed that the 2-week combination NRT group had the lowest cost per quit ($442 vs. $464 for 2-week patch only, $505 for 6-week patch only, and $675 for 6-week combination NRT). CONCLUSIONS: Combination NRT for 2 or 6 weeks increased 6-month abstinence rates by 10% and 13%, respectively, over rates produced by 2 weeks of nicotine patch when offered with quitline counseling. A 10% improvement would potentially yield an additional 50,000 quitters annually, assuming 500,000 callers to U.S. quitlines per year.

Creating a perfect storm to increase consumer demand for Wisconsin's Tobacco Quitline.

BACKGROUND: Telephone quitlines are a clinically proven and cost-effective population-wide tobacco-dependence treatment, and this option is now available in all 50 states. Yet, only 1% of the smoking population accesses these services annually. This report describes a series of policy, programmatic, and communication initiatives recently implemented in Wisconsin that resulted in a dramatic increase in consumer demand for the Wisconsin Tobacco Quitline (WTQL). INTERVENTION: In 2007, the Wisconsin legislature voted to increase the state cigarette excise tax rate by $1.00, from $0.77/pack to $1.77/pack effective January 1, 2008. In preparation for the tax increase, the Wisconsin Tobacco Prevention and Control Program, the University of Wisconsin Center for Tobacco Research and Intervention, which manages the WTQL, and the state's quitline service provider, Free & Clear, Inc., collaborated to enhance quitline knowledge, availability, and services with the goal of increasing consumer demand for services. The enhancements included for the first time, a free 2-week supply of over-the-counter nicotine replacement medication for tobacco users who agreed to receive multi-session quitline counseling. A successful statewide earned media campaign intensified the impact of these activities, which were timed to coincide with temporal smoking-cessation behavioral patterns (i.e., New Year's resolutions). RESULTS: As a result, the WTQL fielded a record 27,000 calls during the first 3 months of 2008, reaching nearly 3% of adult Wisconsin smokers. CONCLUSIONS: This experience demonstrates that consumer demand for quitline services can be markedly enhanced through policy and communication initiatives to increase the population reach of this evidence-based treatment.