Alana M. Rojewski

Addressing the Evidence for FDA Nicotine Replacement Therapy Label Changes: A Policy Statement of the Association for the Treatment of Tobacco Use and Dependence and the Society for Research on Nicotine and Tobacco

Cigarette smoking creates a substantial public health burden. Identifying new, effective smoking cessation interventions that optimize existing interventions and promoting effective use of approved medications is a priority. When used as directed, nicotine replacement therapy (NRT) aids smoking cessation, but there is opportunity for improving its effectiveness. Until recently, NRT use guidelines advised smokers to begin using NRT on their quit date, only to use 1 NRT formulation at a time, to refrain from using NRT while smoking, and to stop NRT within 3 months regardless of progress. The Food and Drug Administration (FDA) issued a recent announcement allowing for NRT labeling changes with applications from pharmaceutical companies for such changes, and we applaud this decision. Nevertheless, additional revisions are warranted by current research. There is robust evidence that combining a longer-acting form (e.g., patch) with a shorter-acting form (e.g., lozenge) is more effective than NRT monotherapy and is safe. Moreover, extant evidence suggests that NRT use prior to a quit attempt or for smoking reduction as part of a quit attempt is safe and as effective as starting NRT on quit date. Specifically, prequit nicotine patch increases quit rates and may engage additional recalcitrant smokers. Last, NRT use longer than 3 months is safe and may be beneficial for relapse prevention in some smokers. This report summarizes the FDA announcement, reviews the evidence for further revisions to current FDA NRT guidelines, and makes recommendations for over-the-counter (OTC) NRT labeling to allow for (1) combined use of faster-acting NRT medications with nicotine patch, (2) nicotine patch use prior to quit date or NRT for smoking reduction as part of a quit attempt, and (3) prolonged NRT for up to 6 months without healthcare provider consultation.

Quitting smoking will benefit your health: the evolution of clinician messaging to encourage tobacco cessation.

Illnesses that are caused by smoking remain as the worlds leading cause of preventable death. Smoking and tobacco use constitute approximately 30% of all cancer-related deaths and nearly 90% of lung cancer–related deaths. Thus, improving smoking cessation interventions is crucial to reduce tobacco use and assist in minimizing the burden of cancer and other diseases in the United States. This review focuses on the existing research on framed messages to promote smoking cessation. Consistent with the tenets of prospect theory and recent meta-analysis, gain-framed messages emphasizing the benefits of quitting seem to be preferable when working with adult patients who smoke tobacco products. The evidence also suggests that moderators of treatment should guide framed statements made to patients. Meta-analyses have provided consistent moderators of treatment such as need for cognition, but future studies should further define the specific framed interventions that would be most helpful for subgroups of smokers. In conclusion, instead of using loss-framed statements like “Smoking will harm your health by causing problems like lung and other cancers, heart disease, and stroke,” as a general rule, physicians should use gain-framed statements like “Quitting smoking will benefit your health by preventing problems like lung and other cancers, heart disease, and stroke.” Clin Cancer Res; 20(2); 301–9. ©2014 AACR.

Menthol Cigarette Use Predicts Treatment Outcomes of Weight-Concerned Smokers

BACKGROUND Studies have shown that individuals who smoke menthol cigarettes are less likely to quit smoking and more likely to relapse during a quit attempt. The current study investigated menthol cigarette use as a potential predictor of smoking cessation outcomes in a sample of treatment-seeking smokers. METHODS This is a secondary analysis of data from a randomized controlled trial of low-dose naltrexone augmentation of nicotine replacement designed to examine smoking cessation and postcessation weight gain in weight-concerned smokers. RESULTS Analyses revealed that menthol use predicted lower quit rates. Among menthol smokers (N = 61), 13% were abstinent at week 26, and among nonmenthol smokers (N = 105), 30% were abstinent (Wald = 4.15, p = .04; odds ratio [OR] = 2.47; 95% CI = 1.04-5.90). Further, menthol smokers who quit smoking gained significantly more weight at week 26 (M = 14.87 lbs, SD = 9.08; t(37) = -2.22, p = .03) than nonmenthol smokers who quit (M = 7.95 lbs, SD = 7.53). CONCLUSIONS Menthol cigarette use has not typically been evaluated as a predictor of smoking cessation outcomes, but emerging evidence suggests that consumption of menthol may make cessation more difficult. This study adds to the literature supporting the claim that smoking menthol cigarettes can have adverse effects on smoking cessation efforts and on other cessation-related outcomes, such as postcessation weight gain.

The Yale Craving Scale: Development and psychometric properties

INTRODUCTION The current study presents a psychometric evaluation of the Yale Craving Scale (YCS), a novel measure of craving for cigarettes and alcohol, respectively. The YCS is the first craving measure to use a generalized Labeled Magnitude Scale (gLMS) as the scoring format, which facilitates between-group comparisons of subjective craving and eliminates ceiling effects by assessing the full range of imaginable sensation intensities. METHODS Psychometric evaluations of the YCS for use with cigarettes (YCS Smoking) and alcohol (YCS Drinking) included assessments of latent factor structure, internal consistency, ceiling effects, and test-criterion relationships. Study samples included 493 treatment-seeking smokers and 213 heavy drinkers. RESULTS Factor analyses of the 5-item YCS Smoking and Drinking scores confirmed a 1-factor scale. The YCS Smoking and Drinking scores evidenced: (1) good internal consistency, (2) scalar measurement invariance within several subgroups (e.g., smoking/drinking status; nicotine/alcohol dependence), (3) convergent relationships with extant craving measures, and (4) concurrent relationships with smoking/drinking outcomes. CONCLUSIONS These results suggest that the YCS represents a psychometrically sound scale for assessing smoking and drinking urges in dependent populations.

A Pilot Clinical Trial of Smoking Cessation Services Implemented in the Workplace for Service Industry Employees

Purpose: Evaluate the feasibility and preliminary efficacy of implementing evidence-based tobacco treatment at the workplace for service industry employees. Design: Randomized trial using 6 paired worksites (3 test and 3 delayed intervention control sites). Setting: US Northeast city. Participants: Employees were recruited from university food service settings. Intervention: Comprehensive smoking treatment was provided at the workplace including individual counseling, free pharmacotherapy (dual nicotine replacement therapy or varenicline), and 5 weeks of contingency management that reinforced abstinence or reductions in smoking to encourage progress toward quitting. Measures: Primary measures included a smoking status survey administered at the end of treatment at the test sites and before treatment began at the delayed intervention control sites. Analysis: Analyses compared rates of quit attempts and successful abstinence for at least 24 hours between the test and delayed intervention control sites. Results: Twenty-five employees were enrolled in treatment. The majority were single (12/25), black (16/25), and reported their educational attainment as high school or less (18/25). Employees in the test (vs delayed intervention control) sites reported higher rates of quit attempts (66.7% vs 12.5%, P = .02) and success quitting for at least 24 hours (53.3% vs 12.5%, P = .08). Participants rated the treatment as very helpful overall. Conclusion: Findings support the feasibility and efficacy of providing workplace-based smoking cessation services and may inform strategies to increase access to treatment.