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IMPORTANCE: Electronic cigarettes (e-cigarettes) for smoking cessation remain controversial. OBJECTIVE: To evaluate e-cigarettes with individual counseling for smoking cessation. DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial enrolled adults motivated to quit smoking from November 2016 to September 2019 at 17 Canadian sites (801 individuals screened; 274 ineligible and 151 declined). Manufacturing delays resulted in early termination (376/486 participants, 77% of target). Outcomes through 24 weeks (March 2020) are reported. INTERVENTIONS: Randomization to nicotine e-cigarettes (n = 128), nonnicotine e-cigarettes (n = 127), or no e-cigarettes (n = 121) for 12 weeks. All groups received individual counseling. MAIN OUTCOMES AND MEASURES: The primary end point was point prevalence abstinence (7-day recall, biochemically validated using expired carbon monoxide) at 12 weeks, changed from 52 weeks following early termination. Participants missing data were assumed to be smoking. The 7 secondary end points, examined at multiple follow-ups, were point prevalence abstinence at other follow-ups, continuous abstinence, daily cigarette consumption change, serious adverse events, adverse events, dropouts due to adverse effects, and treatment adherence. RESULTS: Among 376 randomized participants (mean age, 52 years; 178 women [47%]), 299 (80%) and 278 (74%) self-reported smoking status at 12 and 24 weeks, respectively. Point prevalence abstinence was significantly greater for nicotine e-cigarettes plus counseling vs counseling alone at 12 weeks (21.9% vs 9.1%; risk difference [RD], 12.8 [95% CI, 4.0 to 21.6]) but not 24 weeks (17.2% vs 9.9%; RD, 7.3 [95% CI, –1.2 to 15.7]). Point prevalence abstinence for nonnicotine e-cigarettes plus counseling was not significantly different from counseling alone at 12 weeks (17.3% vs 9.1%; RD, 8.2 [95% CI, –0.1 to 16.6]), but was significantly greater at 24 weeks (20.5% vs 9.9%; RD, 10.6 [95% CI, 1.8 to 19.4]). Adverse events were common (nicotine e-cigarette with counseling: 120 [94%]; nonnicotine e-cigarette with counseling: 118 [93%]; counseling only: 88 [73%]), with the most common being cough (64%) and dry mouth (53%). CONCLUSIONS AND RELEVANCE: Among adults motivated to quit smoking, nicotine e-cigarettes plus counseling vs counseling alone significantly increased point prevalence abstinence at 12 weeks. However, the difference was no longer significant at 24 weeks, and trial interpretation is limited by early termination and inconsistent findings for nicotine and nonnicotine e-cigarettes, suggesting further research is needed. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02417467

IMPORTANCE: Persistent smoking may cause adverse outcomes among patients with cancer. Many cancer centers have not fully implemented evidence-based tobacco treatment into routine care. OBJECTIVE: To determine the effectiveness of sustained telephone counseling and medication (intensive treatment) compared with shorter-term telephone counseling and medication advice (standard treatment) to assist patients recently diagnosed with cancer to quit smoking. DESIGN, SETTING, AND PARTICIPANTS: This unblinded randomized clinical trial was conducted at Massachusetts General Hospital/Dana-Farber/Harvard Cancer Center and Memorial Sloan Kettering Cancer Center. Adults who had smoked 1 cigarette or more within 30 days, spoke English or Spanish, and had recently diagnosed breast, gastrointestinal, genitourinary, gynecological, head and neck, lung, lymphoma, or melanoma cancers were eligible. Enrollment occurred between November 2013 and July 2017; assessments were completed by the end of February 2018. INTERVENTIONS: Participants randomized to the intensive treatment (n = 153) and the standard treatment (n = 150) received 4 weekly telephone counseling sessions and medication advice. The intensive treatment group also received 4 biweekly and 3 monthly telephone counseling sessions and choice of Food and Drug Administration–approved cessation medication (nicotine replacement therapy, bupropion, or varenicline). MAIN OUTCOME AND MEASURES: The primary outcome was biochemically confirmed 7-day point prevalence tobacco abstinence at 6-month follow-up. Secondary outcomes were treatment utilization rates. RESULTS: Among 303 patients who were randomized (mean age, 58.3 years; 170 women [56.1%]), 221 (78.1%) completed the trial. Six-month biochemically confirmed quit rates were 34.5% (n = 51 in the intensive treatment group) vs 21.5% (n = 29 in the standard treatment group) (difference, 13.0% [95% CI, 3.0%-23.3%]; odds ratio, 1.92 [95% CI, 1.13-3.27]; P

Few topics in public health and medicine are as contentious as electronic cigarettes (e-cigarettes), novel handheld battery-operated nicotine-delivery devices that resemble conventional tobacco cigarettes and simulate the experience of smoking a cigarette.1-3 Unlike cigarettes that burn tobacco to generate smoke, e-cigarettes heat a liquid consisting of nicotine, propylene glycol or glycerin, flavorings, and other chemicals to create a vapor that is inhaled. Both conventional cigarettes and e-cigarettes deliver nicotine, the addictive agent in tobacco, but e-cigarettes do not expose the user to the many other tobacco smoke constituents responsible for causing tobacco-related diseases. e-Cigarettes therefore offer the tantalizing prospect that they could reduce the harms of conventional tobacco use, the leading cause of preventable death and disability in the United States and worldwide.4 e-Cigarettes have substantial consumer appeal, generating an estimated $2.2 billion in revenue in the United States in 2014.5 Their use by adults and adolescents in the United States has increased substantially.6,7 Their novel design and consumerappealmakee-cigarettesa“disruptive technology,”3 andtheirpotentialbenefitsandharmsaresubstantial andhotly debated.1,2 Meanwhile, the characteristics of these products are evolving; newer generationsdelivermorenicotine and resemble cigarettes less.8 Thus, e-cigarettes raise many questions forwhich thereare fewanswers.Theevidencebase is limited because e-cigarettes entered the marketplace without being regulated as either drugs or devices. The primary potential benefit of e-cigarettes is to reduce the prevalence of tobacco use by helping current smokers to quit or to switch completely and permanently from combustible tobacco to e-cigarette use. Dual use involving substituting someconventional cigaretteswith e-cigaretteswouldprovide far lessbenefit.However, anybenefitofe-cigaretteswould be offset to the extent that these products are harmful. The 3 principal public health concerns about e-cigarettes are their potential to renormalize cigarette use if they are permitted in venueswhere cigarettes are banned; their potential appeal to nonsmokers, especially to children and adolescents; and their possible health risks as a result of users’ exposure to e-cigarette constituents, such as flavorings or propylene glycol, or to e-cigarette contaminants.9 e-Cigarettes could increase tobacco use initiation rates if youthswhowouldnothaveotherwise triedconventional cigarettes try e-cigarettes, becomeaddicted tonicotine, and transition tousingcombustible tobaccoproducts.Adolescentsmay be especially susceptible to develop nicotine addiction after e-cigarette exposure because their brains are still developing and are particularly sensitive to nicotine.4 There is universal agreement that this is not a good outcome, and there is concern that it could occur because e-cigarettes are marketed in ways that appeal to youth.8 Whetheradolescents’useofe-cigarettespredisposes them to initiate conventional tobacco use is a critical question for assessing the net public health effect of e-cigarettes. The existing evidence derives from cross-sectional studies. In a nationally representative sample of US middle and high school students from 2011-2013, ever use of e-cigarettes was associated with conventional tobacco product use and with a measure of susceptibility to start smoking in the future,10 consistentwith anearlier analysis.11 In anational surveyofUSyoung adults from 2012-2013, ever use of e-cigarettes was associatedwithanopenness to smokeconventional cigarettes.12 The associations observed in these studies persisted after statistical adjustment for potential confounders, but crosssectional studydesigns cannot establish causality or the temporal direction of observed relationships.13 A longitudinal study can help untangle the temporality of these relationships. In this issue of JAMA, Leventhal and colleagues14 report findings fromsuchastudy.Theauthorsused a repeated-measuresprospectiveobservational studydesign to assess combustible tobacco and e-cigarette use among a diverse cohort of 2530 ninth graders attending 10 public high schools in Los Angeles, California, from 2013-2014.14 At baseline, all students were nonsmokers (defined has never having used a combustible tobacco product, including cigarettes, cigars, blunts, and hookah); 222 (8.8%) of them had ever used an e-cigarette. Nonsmokers with previous exposure to e-cigarettes at initial interview compared with those without exposure toe-cigarettesweremore likely to reportuseofacombustible tobacco product during the next 6 months (30.7% vs 8.1%, respectively) and 12 months (25.2% vs 9.3%, respectively). Significant associations also were found for each individual tobacco product, including cigarettes, cigars, and hookah. The investigators carefully adjusted the analysis for manyknownsociodemographic, family,environmental,andintrapersonal factors associated with e-cigarette and combustible tobacco use. This adjustment substantially lowered the magnitude of the association between e-cigarettes and subsequent tobaccouse (odds ratio [OR]declined from4.27 [95%CI, 3.19-5.71] to 2.73 [95%CI, 2.00-3.73]), suggesting that these facAuthor Audio Interview at jama.com

Varenicline, a partial agonist at the alpha4beta2 nicotinic acetylcholine receptor, has the potential to aid smoking cessation by relieving nicotine withdrawal symptoms and reducing the rewarding properties of nicotine.To determine the efficacy and safety of varenicline for smoking cessation compared with placebo or sustained-release bupropion (bupropion SR).A randomized, double-blind, placebo-controlled trial conducted between June 2003 and March 2005 at 14 research centers with a 12-week treatment period and follow-up of smoking status to week 52. Of 1413 adult smokers who volunteered for the study, 1027 were enrolled; 65% of randomized participants completed the study.Varenicline titrated to 1 mg twice daily (n = 344) or bupropion SR titrated to 150 mg twice daily (n = 342) or placebo (n = 341) for 12 weeks, plus weekly brief smoking cessation counseling.Continuous abstinence from smoking during the last 4 weeks of treatment (weeks 9-12; primary end point) and through the follow-up period (weeks 9-24 and 9-52).During the last 4 weeks of treatment (weeks 9-12), 43.9% of participants in the varenicline group were continuously abstinent from smoking compared with 17.6% in the placebo group (odds ratio [OR], 3.85; 95% confidence interval [CI], 2.69-5.50; P.001) and 29.8% in the bupropion SR group (OR, 1.90; 95% CI, 1.38-2.62; P.001). For weeks 9 through 24, 29.7% of participants in the varenicline group were continuously abstinent compared with 13.2% in the placebo group (OR, 2.83; 95% CI, 1.91-4.19; P.001) and 20.2% in the bupropion group (OR, 1.69; 95% CI, 1.19-2.42; P = .003). For weeks 9 through 52, 23% of participants in the varenicline group were continuously abstinent compared with 10.3% in the placebo group (OR, 2.66; 95% CI, 1.72-4.11; P.001) and 14.6% in the bupropion SR group (OR, 1.77; 95% CI, 1.19-2.63; P = .004). Treatment was discontinued due to adverse events by 10.5% of participants in the varenicline group, 12.6% in the bupropion SR group, and 7.3% in the placebo group. The most common adverse event with varenicline was nausea, which occurred in 101 participants (29.4%).Varenicline is an efficacious, safe, and well-tolerated smoking cessation pharmacotherapy. Varenicline's short-term and long-term efficacy exceeded that of both placebo and bupropion SR.clinicaltrials.gov Identifier: NCT00143364.

Importance Health care systems need effective models to manage chronic diseases like tobacco dependence across transitions in care. Hospitalizations provide opportunities for smokers to quit, but research suggests that hospital-delivered interventions are effective only if treatment continues after discharge. Objective To determine whether an intervention to sustain tobacco treatment after hospital discharge increases smoking cessation rates compared with standard care. Design, Setting, and Participants A randomized clinical trial compared sustained care (a postdischarge tobacco cessation intervention) with standard care among 397 hospitalized daily smokers (mean age, 53 years; 48% were males; 81% were non-Hispanic whites) who wanted to quit smoking after discharge and received a tobacco dependence intervention in the hospital; 92% of eligible patients and 44% of screened patients enrolled. The study was conducted from August 2010 through November 2012 at Massachusetts General Hospital. Interventions Sustained care participants received automated interactive voice response telephone calls and their choice of free smoking cessation medication (any type approved by the US Food and Drug Administration) for up to 90 days. The automated telephone calls promoted cessation, provided medication management, and triaged smokers for additional counseling. Standard care participants received recommendations for postdischarge pharmacotherapy and counseling. Main Outcomes and Measures The primary outcome was biochemically confirmed past 7-day tobacco abstinence at 6-month follow-up after discharge from the hospital; secondary outcomes included self-reported tobacco abstinence. Results Smokers randomly assigned to sustained care (n = 198) used more counseling and more pharmacotherapy at each follow-up assessment than those assigned to standard care (n = 199). Biochemically validated 7-day tobacco abstinence at 6 months was higher with sustained care (26%) than with standard care (15%) (relative risk [RR], 1.71 [95% CI, 1.14-2.56], P = .009; number needed to treat, 9.4 [95% CI, 5.4-35.5]). Using multiple imputation for missing outcomes, the RR for 7-day tobacco abstinence was 1.55 (95% CI, 1.03-2.21; P = .04). Sustained care also resulted in higher self-reported continuous abstinence rates for 6 months after discharge (27% vs 16% for standard care; RR, 1.70 [95% CI, 1.15-2.51]; P = .007). Conclusions and Relevance Among hospitalized adult smokers who wanted to quit smoking, a postdischarge intervention providing automated telephone calls and free medication resulted in higher rates of smoking cessation at 6 months compared with a standard recommendation to use counseling and medication after discharge. These findings, if replicated, suggest an approach to help achieve sustained smoking cessation after a hospital stay. Trial Registration clinicaltrials.gov Identifier:NCT01177176

Context.—Routine treatment of smokers by physicians is a national health objective for the year 2000, a quality measure for health care plans, and the subject of evidence-based clinical guidelines. There are few national data on how physicians' practices compare with these standards.Objective.—To assess recent trends in the treatment of smokers by US physicians in ambulatory care and to determine whether physicians' practices meet current standards.Design.—Analysis of 1991-1995 data from the National Ambulatory Medical Care Survey, an annual survey of a random sample of US office-based physicians.Setting.—Physicians' offices.Patients.—A total of 3254 physicians recorded data on 145716 adult patient visits.Main Outcome Measures.—The proportion of visits at which physicians (1) identified a patient's smoking status, (2) counseled a smoker to quit, and (3) used nicotine replacement therapy.Results.—Smoking counseling by physicians increased from 16% of smokers' visits in 1991 to 29% in 1993 (P

Tobacco use is the leading preventable cause of death worldwide. Stopping tobacco use benefits virtually every smoker. Most of the 19% of US residents who smoke want to quit and have tried to do so. Most individual quit attempts fail, but two-thirds of smokers use no treatment when trying to quit. Treating tobacco dependence is one of the most cost-effective actions in health care. With a brief intervention, physicians can prompt smokers to attempt to quit and connect them to evidence-based treatment that includes pharmacotherapy and behavioral support (ie, counseling). Physicians can link smokers to effective counseling support offered by a free national network of telephone quit lines. Smokers who use nicotine replacement therapy (NRT), bupropion, or varenicline when trying to quit double their odds of success. The most effective way to use NRT is to combine the long-acting nicotine patch with a shorter-acting product (lozenge, gum, inhaler, or nasal spray) and extend treatment beyond 12 weeks. Observational studies have not confirmed case reports of behavior changes associated with varenicline and bupropion, and these drugs' benefits outweigh potential risks. A chronic disease management model is effective for treating tobacco dependence, which deserves as high a priority in health care systems as treating other chronic diseases like diabetes and hypertension.

Objective. —To assess the prevalence, content, and growth of state and city laws restricting smoking in public places and workplaces in the United States and to identify factors associated with their passage. Design. —A mailed survey of city clerks in US cities with a population of 25000 or greater (N =980) and review of existing data sources confirmed the status of smoking restrictions in 902 (92%) of the cities in the sample. State laws were identified by contacting each state's Legislative Reference Bureau (100% response). Content of laws was coded using previously developed categories. Main Outcome Measures. —Prevalence, comprehensiveness, and cumulative incidence of no-smoking laws in states and in cities with a population of 25000 or greater. Results. —By July 1989, 44 states and 500 (51%) of the cities in our sample had adopted some smoking restriction, but content varied widely. While 42% of cities limited smoking in government buildings, 27% in public places, 24% in restaurants, and 18% in private workplaces, only 17% of cities and 20% of states had comprehensive laws restricting smoking in all four of these sites. The number of city no-smoking laws increased tenfold from 1980 to 1989. City no-smoking laws were independently associated with population size, geography, state tobacco production, and adult smoking prevalence. Laws were more common in larger cities, Western cities, and states with fewer adult smokers. Laws were less common in tobacco-producing states and in the South. Conclusions. —No-smoking laws are more widespread than previously appreciated, especially at the local level, reflecting a rapid pace of city government action in the 1980s. Nonetheless, comprehensive laws, which are most likely to provide meaningful protection from environmental tobacco smoke exposure, remain uncommon and represent a major gap in smoking control policy. Laws are most needed in smaller and non-Western cities and in states that produce tobacco and have a higher proportion of smokers. (JAMA. 1991;266:3162-3167)

ContextVarenicline, a partial agonist at the α4β2 nicotinic acetylcholine receptor, has the potential to aid smoking cessation by relieving nicotine withdrawal symptoms and reducing the rewarding properties of nicotine.ObjectiveTo determine the efficacy and safety of varenicline for smoking cessation compared with placebo or sustained-release bupropion (bupropion SR).Design, Setting, and ParticipantsA randomized, double-blind, placebo-controlled trial conducted between June 2003 and March 2005 at 14 research centers with a 12-week treatment period and follow-up of smoking status to week 52. Of 1413 adult smokers who volunteered for the study, 1027 were enrolled; 65% of randomized participants completed the study.InterventionVarenicline titrated to 1 mg twice daily (n = 344) or bupropion SR titrated to 150 mg twice daily (n = 342) or placebo (n = 341) for 12 weeks, plus weekly brief smoking cessation counseling.Main Outcome MeasuresContinuous abstinence from smoking during the last 4 weeks of treatment (weeks 9-12; primary end point) and through the follow-up period (weeks 9-24 and 9-52).ResultsDuring the last 4 weeks of treatment (weeks 9-12), 43.9% of participants in the varenicline group were continuously abstinent from smoking compared with 17.6% in the placebo group (odds ratio [OR], 3.85; 95% confidence interval [CI], 2.69-5.50; P

Context.—Adolescent smoking prevalence is tracked annually and has increased since 1991. In contrast, little is known about trends in smoking among college students, a group that has previously been more resistant to tobacco use than other young adults.Objective.—To examine changes in cigarette smoking among college students between 1993 and 1997 and among different types of students and colleges.Design.—Self-administered survey (Harvard School of Public Health College Alcohol Study).Setting.—One hundred sixteen nationally representative 4-year colleges.Subjects.—A total of 15,103 randomly selected students in 1993 (70% response rate) and 14,251 students in 1997 (60% response rate).Main Outcome Measures.—Self-reports of cigarette smoking in the past 30 days and in the past year, age at smoking first cigarette, and number of attempts to quit.Results.—Over 4 years, the prevalence of current (30-day) cigarette smoking rose by 27.8%, from 22.3% to 28.5% (P