Michael B. Steinberg

Lower quit rates among African American and Latino menthol cigarette smokers at a tobacco treatment clinic

Background:  Lower rates of smoking cessation and higher rates of lung cancer in African American (AA) smokers may be linked to their preference for mentholated cigarettes.

Patterns of Electronic Cigarette Use Among Adults in the United States

INTRODUCTION Amid increasing rates of electronic cigarette (e-cigarette) use in the United States, there is an urgent need to monitor patterns of use at the population level in order to inform practice, policy and regulation. This article examines how patterns of e-cigarette use among adults differ between users and nonusers of cigarettes using the most current national data. METHODS We analyzed data from the 2014 National Health Interview Survey. We estimated prevalence of ever, current, and daily e-cigarette use and examined how use patterns differed by demographic subgroups and measures of cigarette smoking status that accounted for the recent availability of e-cigarettes in the US marketplace. RESULTS Current e-cigarette use is extremely low among never cigarette smokers (0.4%) and former smokers who quit cigarettes 4 or more years ago (0.8%). Although e-cigarette experimentation is most common among current cigarette smokers and young adults, daily use is highest among former smokers who quit in the past year (13.0%) and older adults. Compared to daily cigarette smokers, recently quit smokers were more than four times as likely to be daily users of e-cigarettes (AOR: 4.33 [95% CI: 3.08-6.09]). CONCLUSIONS Extremely low e-cigarette use among never-smokers and longer term former smokers suggest that e-cigarettes neither promote widespread initiation nor relapse among adults. Recognition of the heterogeneity of smokers, including the time since quitting, is critical to draw accurate conclusions about patterns of e-cigarette use at the population level and its potential for public health benefit or harm. IMPLICATIONS Data from 2014 National Health Interview Survey indicate that e-cigarettes have not been attracting adult non-smokers or promoting relapse in longer term former smokers. Moreover, the data are suggestive that some recent quitters may have done so with the assistance of e-cigarettes. Creating measures of smoking status that treat former smokers as a homogenous group is insufficient to assess the epidemiology of e-cigarette use and the potential impact on public health.

Developments in pharmacotherapy for tobacco dependence: past, present and future

In the mid-1970s there were no effective pharmacological treatments for tobacco dependence. The invention of nicotine gum was a major treatment advance and also greatly helped our understanding of the nature of tobacco dependence. There are now eight effective pharmacotherapies (nicotine gum, patch, nasal spray, inhaler, lozenge/tablet, bupropion, nortriptyline and clonidine) available to aid smoking cessation. Other non-nicotine agents that show promise are under investigation, including glucose, rimonabant, selegiline and varenicline. Greater knowledge of the mechanisms of action of the effective non-nicotine agents should lead to better understanding of the nature of tobacco dependence. Future research into optimal treatments should examine long-term combination pharmacotherapy combined with improved psychosocial support that is partly designed to enhance medication compliance. In addition, there is a need for studies designed to evaluate the efficacy of pharmacotherapies in populations such as youth, pregnant smokers and smokers with co-occurring mental health problems.

The Case for Treating Tobacco Dependence as a Chronic Disease

Most smokers are aware of the numerous health risks associated with smoking, and the majority report wanting to quit (1). Strong evidence suggests that smokers who utilize treatment in the forms of behavioral counseling and pharmacotherapy have an increased chance of success compared with those who do not receive such treatment. Seven first-line medications have been approved by the U.S. Food and Drug Administration for smoking cessation, including nicotine replacement therapy (NRT) (patch, gum, lozenge, inhaler, nasal spray), bupropion, and varenicline (2). Despite the proven benefits of these medications, a mere 17% of all smokers utilize pharmacotherapy for tobacco dependence each year (3). Our case report describes an example of a smoker who has been successful at quitting smoking only through long-term use of nicotine replacement medication. Case Report A 41-year-old woman presented for treatment to a specialty tobacco clinic. She had previously quit smoking in March 2000 for 2 years using a nicotine inhaler. In March 2002, her primary care doctor felt she was becoming addicted to the inhaler and declined to continue to prescribe it. On stopping the medication, the patient quickly relapsed to smoking. She presented for treatment in July 2002 after returning to smoking for 4 months. At that time, she smoked 20 nonmenthol cigarettes per day, smoking her first cigarette of the day 1 minute after waking in the morning. Her medical history included depression, anxiety, and hyperlipidemia. She had a bachelors degree and worked as an administrator. On examination, her exhaled carbon monoxide concentration was 21 parts per million (ppm); a typical range for a nonsmoker is 0 to 4 ppm. Her treatment plan included group behavioral treatment, a 21-mg nicotine patch worn daily, and a nicotine inhaler as needed. After successfully obtaining insurance coverage, albeit with some difficulty, she set a quit date and was successful in stopping smoking in August 2002. The patient was reevaluated in February 2007. She had not smoked since her quit date 4.5 years earlier. She used 28 inhaler cartridges per day. Her blood nicotine level was 25 ng/mL and blood cotinine level was 390 ng/mL (both of which are in the range of a moderate regular smoker). Her exhaled carbon monoxide concentration was 0 ppm, which confirmed that she was not smoking. She reported no ill effects from the nicotine inhaler and feared that she would once again relapse to smoking if she stopped the medication. At this point, her insurance company no longer agreed to cover the medication. Long-Term Use of Cessation Medications versus Long-Term Cigarette Smoking Many smokers are misinformed about the safety of nicotine medications and other available cessation pharmacotherapies. Most smokers incorrectly reported that nicotine was the primary cause of cancer, and only one third correctly stated that the nicotine patch was less likely than cigarette smoking to cause a heart attack (3). In fact, NRT is safe even at high doses (4) and in high-risk populations, such as persons with existing cardiovascular disease (5). Although dependence on NRT is possible, the overall chance of addiction as reported in the literature is very low, generally under 10% (6). The optimal duration of treatment remains unclear (7), but a single, brief treatment course with NRT results in long-term abstinence in only a few smokers. Relapse is a hallmark of this chronic condition: Of persons who quit smoking by using NRT and achieve abstinence at 12 months, an estimated 30% subsequently relapse (8). Extending the duration of NRT treatment for longer periods may be beneficial (2) and could prevent relapse (9). In clinical trials, nicotine inhaler use extended for up to 1 year increased abstinence rates at 12 months compared with placebo (10). In the Lung Health Study (11), 31% of participants continued using nicotine gum safely and effectively for over 1 year. Some participants continued gum use for up to 5 years without any serious side effects. In addition, data indicate that use of bupropion and varenicline for up to 1 year is effective and safe (12, 13). Long-term medication use in patients requiring extended courses of treatment is also supported by the updated U.S. Public Health Service Guidelines (2). Because quitters using long-term pharmacotherapy are exposed to lower levels of nicotine without the 4000 toxins found in cigarette smoke, there is a clear overall health benefit if the individual no longer smokes cigarettes (9). Tobacco Dependence Treatment Should Be Considered the Same as Treatment of Other Chronic Medical Conditions For some smokers, long-term pharmacotherapy is the difference between tobacco abstinence and lifelong smoking. Although long-term use of nicotine replacement therapy, as described in our case, is not typical, it is much safer than continuing to smoke cigarettes. Health care providers should remain open-minded to patients who may require a unique course of treatment. Although long-term use is considered off-label, patients should be encouraged to remain smoke-free, and if extended courses of pharmacotherapy will assist them, treatment should be continued, encouraged, and reimbursed. Rather than considering cessation medications as a short-term aid in smoking cessation, these medications should be covered in the same manner as treatment of other long-term illnesses and conditions, such as asthma, depression, and diabetes, given the chronic, relapsing nature of tobacco dependence (Table) (1419). The neurobiochemical effects of tobacco use are well documented and result in measurable and lasting changes in brain structure (for example, upregulation of nicotinic receptors) and brain function (for example, changes in the electroencephalogram), some of which can be objectively measured by imaging techniques, especially in the mesolimbic reward center (20). These biological changes are a hallmark of a chronic medical condition, and discontinuation of tobacco use results in physiologic changes within the brain and a subsequent withdrawal syndrome (2). Table. Comparison of Diabetes and Tobacco Use Pharmacotherapies have been proven effective in treating these withdrawal symptoms, but a major barrier to obtaining treatment is insurance coverage. Despite the cost-effectiveness of tobacco treatment medications compared with other commonly prescribed medical interventions, insurance carriers often do not cover proven cessation therapies or the duration of therapy is severely curtailed (2). With other serious addictions, such as heroin, proven medications (such as methadone) to prevent relapse are commonly provided long-term. This is not the case with tobacco treatment medications, even though tobacco kills far more of its users than any other addiction. Physicians and insurers view tobacco dependence like other addictions that do not garner the same respect as medical diagnosesin fact, it carries a certain stigma. The reality is that tobacco use kills more people than many classic medical diseases. It should not matter whether the site of disease is in the lung with airway hyperreactivity (asthma), in the adipose tissue with insulin resistance (diabetes), or in the nucleus accumbens (tobacco dependence). The outcomes of morbidity and mortality are what should concern patients, health care providers, and payers. It is time to move beyond the antiquated categorization of tobacco use as just a bad habit and to provide effective treatment. Thus, these stakeholders should regard tobacco dependence as the chronic medical condition that it represents. With repeated assistance, our patient continued to receive the nicotine inhaler through her insurance carrier and has remained abstinent from tobacco for over 5 years. From her example and from the scientific evidence, the long-term use of medications for the treatment for tobacco dependence can result in continued abstinence and the associated reduction in negative health consequences. In summary, the prevalence of tobacco use and death rates from smoking are higher than those of other chronic conditions, such as diabetes. Both conditions improve with comprehensive, cost-effective treatments, including combined pharmacotherapy and behavioral components. However, whereas long-term treatments for diabetes are commonly reimbursed by health insurance, those for tobacco dependence often are not. Covering both behavioral and pharmacologic measures to assist in smoking cessation will increase the demand for and accessibility to effective treatment options and has been called for in a State-of-the-Science Conference Statement by the National Institutes of Health (21). Improving the availability of these benefits will expand the number of smokers who utilize treatment and will increase smoking abstinence rates (2). Tobacco dependence should be recognized as a chronic illness that requires effective treatments as long as the condition exists.

Triple-Combination Pharmacotherapy for Medically Ill Smokers: A Randomized Trial

Context Few studies have examined interventions for smokers with medical illnesses. Contribution In this trial, 127 smokers with medical illness (for example, cardiovascular or chronic obstructive pulmonary disease) were randomly assigned to a nicotine patch for 10 weeks or a combination of a nicotine patch, a nicotine oral inhaler, and bupropion for an ad libitum duration. Abstinence rates at 26 weeks for the groups were 19% and 35%, respectively. Fewer patients who received the nicotine patch versus combination therapy had insomnia (9% vs. 25%) and anxiety (3% vs. 22%). Caution About 25% of participants did not complete follow-up. Implication Combination therapy may improve abstinence rates but causes more insomnia and anxiety than the nicotine patch in smokers with medical illnesses. The Editors Despite a steady decline in tobacco use among adults over the past several decades, smokers with medical illnesses make up a disproportionately high proportion of current smokers (1). In a recent review, up to 58% of smokers continued to use tobacco after a new cancer diagnosis (2) and 50% of smokers started to smoke again within 6 months of myocardial infarction (3). Evidence has shown that smokers with substantial nicotine dependence may benefit from higher-intensity treatment, including combined regimens (48) and extended durations of medications beyond the typical 8- to 12-week course (9). Considerable barriers to effective tobacco dependence treatments continue to exist for smokers (10, 11), especially those with medical illnesses, because of a fear of adverse effects of cessation medications on their medical conditions despite contrary evidence (12). Clinical trials of cessation medications often exclude smokers with medical illnesses, so efficacy and safety data on these smokers are limited. In addition, product labeling negatively affects use of cessation medications by advising against combinations and setting strict 8- to 12-week durations of therapy (13, 14), despite contradictory clinical practice guidelines (8). Observational data from our tobacco treatment clinic indicate the benefit of a triple-medication combination for dependent smokers (15) and the benefit of extended-duration pharmacotherapy (16). To date, only 1 randomized trial has examined a triple-medication combination; this trial was conducted in a selected group of schizophrenic smokers, with treatment duration limited to 12 weeks (17). We sought to evaluate 6-month tobacco abstinence rates for outpatient smokers with medical illnesses who received a combination regimen of nicotine patch, nicotine inhaler, and bupropion or standard-duration nicotine patch therapy alone. Methods Design Overview We conducted our randomized clinical trial from 2005 to 2007 in a primary care medical setting. We compared a flexible-duration, triple-combination treatment regimen with a standard-duration nicotine patch therapy. We recruited participants with predefined medical illnesses from the local community, randomly allocated them to 1 of the treatment groups, and followed them for 6 months after setting a target quit date. We started recruiting smokers on 27 September 2005 and completed follow-up on 18 November 2007. The institutional review board at the University of Medicine and Dentistry of New Jersey, New Brunswick, New Jersey, approved the study protocol. Setting and Participants Participants included smokers who reported smoking an average of at least 10 cigarettes per day (confirmed by high [>10 parts per million] exhaled carbon monoxide level), were 18 years or older, were interested in quitting within the next 30 days, smoked during at least 20 of the past 30 days, and had 1 or more predefined medical illnesses (including cardiovascular disease, other vascular disease, chronic pulmonary disease, cancer, hypertension, diabetes, hyperlipidemia, and recurrent pulmonary infections) but no contraindications to pharmacotherapy (including unstable angina, myocardial infarction within 2 months, severe arrhythmia, seizure disorder, and serious mental illness requiring antipsychotic medications). We excluded participants if they currently used other tobacco products (smokeless tobacco, cigars, or pipes) or bupropion, clonidine, nortriptyline, or nicotine replacement medications or if they were pregnant, planning on becoming pregnant within the next 6 months, or actively abusing other substances. We recruited participants from the local community through flyers and referrals from staff at local clinics and hospitals. We assessed and followed participants in a single outpatient medical office shared by the general internal medicine faculty practice. We described the purpose and methods of the study to potential participants and obtained informed consent from those interested and eligible to participate. Randomization and Interventions During the initial study session, we collected baseline data, including the Fagerstrm test score for nicotine dependence, number of cigarettes smoked per day, time to first cigarette after waking, exhaled carbon monoxide levels, motivation to quit and confidence in ability to quit (Likert scale of 1 to 10), number of years smoked, number of previous quit attempts and duration of previous abstinence, past use of cessation medications, psychiatric comorbid conditions, demographic characteristics (age, sex, race, education), perception of smokings influence on health, general medical history, and smoking behaviors (triggers, barriers, and motivators). We measured exhaled carbon monoxide levels in all participants by having participants hold their breath for 15 seconds, then exhale into a hand-held carbon monoxide monitor (Smokerlyzer Micro III, Bedfont Scientific, Rochester, United Kingdom). A cut-off value of carbon monoxide (8 parts per million) discriminates smokers from nonsmokers with 90% sensitivity and 89% specificity (18). We randomly assigned participants to either a control group given the nicotine patch alone or a group given the nicotine patch, nicotine inhaler, and sustained-release bupropion (combination group). We created computer-generated randomization tables by using block sizes of 4 by the 4 combinations of cigarette consumption (<20 cigarettes/d or 20 cigarettes/d) and severity of medical illness (moderate [cardiovascular risk factors or tobacco caused symptoms] or severe [cardiovascular disease, cancer, or chronic pulmonary disease]). The research nurse called a staff member (unaffiliated with the study) to record the participant on the randomization table, and he or she relayed back the treatment assignment. The assignment was not revealed to the nurse until after the participant was randomly assigned. Participants in both treatment groups received an American Heart Association smoking cessation pamphlet as standard care behavioral intervention. A goal of the study design was to simulate a real-world, primary care experience of tobacco dependence treatment. Therefore, the behavioral intervention component was limited. Participants chose a target quit date that was within 2 weeks from the initial contact. One study physician met with all participants to deliver a strong quit message, do a brief physical examination, and answer questions about use of the medications. We provided nicotine patches to smokers assigned to the patch alone (Nicoderm, GlaxoSmithKline, Research Triangle Park, North Carolina) for a standard 10-week tapering protocol, as described in the package labeling (21 mg/d for 6 weeks, followed by 14 mg/d for 2 weeks and then 7 mg/d for 2 weeks). This treatment was chosen because it represents the most commonly used pharmacologic aid worldwide. Participants in the combination medication group were given a nicotine patch starting at 21 mg/d; a nicotine oral inhaler (to be used as needed); and sustained-release bupropion, 150 mg/d. The duration of treatment in this group was symptom-triggered. We instructed participants to continue their initial medication doses until they had gone 14 consecutive days without noteworthy withdrawal symptoms or cravings for tobacco. At that point, they were instructed to reduce the nicotine patch dosage to 14 mg/d for 2 weeks. If participants continued to feel comfortable, they would further reduce to 7 mg/d for 2 weeks. After this period, if participants remained symptom-free, they would entirely discontinue the patch. During the next 2 weeks, if participants were comfortable, they would then discontinue the bupropion treatment. We used this sequence to maximize the duration that participants used medications with differing mechanisms of action. After this, participants would continue to use a nicotine inhaler as long as they felt it was needed. If the participant had worsening withdrawal symptoms after reducing a level of medication, the medication level would be increased to the previous level until participants were comfortable. Outcomes and Follow-up A single study nurse assessed all participants and conducted all follow-up procedures by using a standard protocol. We scheduled participants for follow-up at weeks 2, 4, 8, 12, 16, 20, 24, and 26 after their target quit date. If they did not attend these appointments, we made up to 5 attempts to contact them by telephone to reschedule before they were considered lost to follow-up. During the initial study session, we provided participants with a 2-week supply of medications until their next appointment, when they were provided with the next 2-week supply. At the 4-week follow-up visit and at subsequent 4-week intervals, we provided participants with a new 4-week supply of medications. At these appointments, we asked participants about tobacco use since their quit date, nicotine withdrawal symptoms, medication use, adverse medication effects, and any medical complications that had occurred. We obtained adverse medication effects by the study nurse through open-ended questions. Each specific symptom or event was docume

Smoking-Cessation Prevalence Among U.S. Smokers of Menthol Versus Non-Menthol Cigarettes

BACKGROUND The Food and Drug Administration currently is assessing the public health impact of menthol cigarettes. Whether menthol cigarettes pose increased barriers to quitting is a critical issue because previous declines in smoking prevalence have stalled. PURPOSE To explore whether menthol cigarette smokers are less likely to quit than non-menthol smokers at the population level and whether this relationship differs by race/ethnicity. METHODS Cross-sectional analyses of the 2003 and 2006/2007 Tobacco Use Supplement to the Current Population Survey were conducted in 2010. Multiple logistic regressions were used to calculate the adjusted odds of cessation for menthol smoking relative to non-menthol smoking. Five different sample restrictions were used to assess the robustness of the findings. RESULTS In the broadest sample restriction, menthol smokers were less likely to have quit smoking (AOR=0.91, 95% CI=0.87, 0.96). This relationship holds among whites (AOR=0.93, 95% CI=0.88, 0.98) and blacks (AOR=0.81, 95% CI=0.67, 0.98). The magnitude of the relationship among Hispanics was similar to that among whites, but differed by Hispanic origin. Among those of Mexican origin, the AOR for menthol smokers was protective but not significant (AOR=1.29, 95% CI=0.99, 1.61), whereas among those of Puerto Rican origin, menthol smokers were less likely to have quit (AOR=0.57, 95% CI=0.37, 0.87). These findings were robust and significant in four of five sample restrictions. CONCLUSIONS Smoking menthol cigarettes is associated with decreased cessation at the population level, and this association is more pronounced among black and Puerto Rican smokers. These findings support the recent calls to ban menthol flavoring in cigarettes.

Waking at night to smoke as a marker for tobacco dependence: patient characteristics and relationship to treatment outcome

Aim:  This study aimed to describe the characteristics of treatment‐seeking patients who wake at night to smoke (night‐smoking), identify factors that may be associated with night‐smoking, and assess the association between night‐smoking and treatment outcome.

Tobacco dependence treatment for hospitalized smokers: A randomized, controlled, pilot trial using varenicline

OBJECTIVE The hospital can be an important opportunity for smoking cessation interventions. This is the first randomized, double-blinded, placebo-controlled pilot trial utilizing varenicline and post-discharge, in-person behavioral treatment for hospitalized smokers. METHOD Seventy-nine smokers admitted to a university-based hospital with various diagnoses were enrolled from 2007 to 2009. The primary outcome was biochemically confirmed abstinence at 24 weeks following discharge. Secondary outcomes included withdrawal symptoms, motivation, utilization of treatment, and medical events. RESULTS Overall abstinence at 24 weeks was 27% with no difference between varenicline and placebo treatment groups (23% vs. 31%). There were no significant differences in motivation to stop smoking or withdrawal symptoms. Over 40% of all subjects utilized post-discharge behavioral treatment with significantly higher abstinence rates compared with those who did not (53.1% vs. 8.5%, p<0.01). Overall adverse events were similar in both treatment groups with the only significant difference being more nausea in the varenicline group (25% vs. 5%; p<0.01). Twenty-three subjects were re-hospitalized with no significant differences between treatment groups (13 varenicline vs. 10 placebo). CONCLUSION This pilot trial of varenicline in hospitalized smokers demonstrated feasibility of implementation, produced some hypothesis-generating findings, and suggested the potential benefit of face-to-face treatment following discharge.

A Comprehensive Model for Mental Health Tobacco Recovery in New Jersey

Despite the high prevalence of tobacco use, disproportionate tobacco consumption, and excess morbidity and mortality, smokers with mental illness have reduced access to tobacco dependence treatment across the health care spectrum. We have developed a comprehensive model for Mental Health Tobacco Recovery in New Jersey (MHTR-NJ) that has the overarching goal of improving tobacco cessation for smokers with serious mental illness. Important steps involve engaging patients, professionals and the community to increase understanding that addressing tobacco use is important. In addition to increasing demand for tobacco treatment services, we must educate mental health professionals in evidence-based treatments so that patients can seek help in their usual behavioral health care setting. Peer services that offer hope and support to smokers are essential. Each of the policy or cessation initiatives described address the two core goals of this model: to increase demand for tobacco cessation services for mentally ill smokers and to help more smokers with mental illness to quit. Each has been pilot tested for feasibility and/or effectiveness and revised with feedback from stakeholders. In this way this implementation model has brought together academics, clinicians, administrators and mental health consumers to develop tobacco programming and policy that has been tested in a real world environment and serves as a model for other states.

Decision counseling for men considering prostate cancer screening

One in six men will develop prostate cancer in their lifetimes; and the risk of dying from the disease is elevated by a factor of at least two among African-American men. Many asymptomatic men who are diagnosed with prostate cancer have their disease detected through a prostate cancer screening examination. The examination often includes both a digital rectal examination and prostate-speci5c antigen testing. Although annual screening is recommended by several organizations, others urge caution since no randomized trials have demonstrated that screening can reduce mortality from prostate cancer. Concern about prostate cancer screening is also based on the fact that diagnosis and treatment of early-stage prostate cancer can cause substantial adverse outcomes. To facilitate shared decision making between the patient and medical practitioner, it is important to provide information that is needed to make an informed decision. In this paper, we discuss the development and implementation of a decision-counseling protocol for prostate cancer screening. This protocol, which incorporates the analytic hierarchy process (AHP), is designed as a decision aid for use in facilitating decision making about whether or not to have a screening examination. We discuss several modi5cations to the standard AHP that were required to 5t the needs of the target population. The counseling protocol has been applied in randomized trials involving diverse populations. While health educators required some training to administer the decision-counseling protocol, none was needed for the patients. The results have demonstrated