Nicotine Dependence Treatment: Keeping an Eye on the Prize

In the United States and globally, nicotine dependence, particularly smoking, remains the leading cause of morbidity and mortality, and cessation of tobacco use is one of the most effective measures in preventing disease and early death. Nicotine dependence, which drives tobacco use, remains an epidemic in the United States, despite historic advances in treatment options, policy interventions, and initiatives at the state and national levels, which have all contributed to a decline in use for both adults and youth. However, there is also an historic increase in the range and type of tobacco and nicotine products which are often unregulated and understudied, and new threats to access to health care and funding for research.

While the prevalence of tobacco use in adult and youth populations is decreasing overall, the prevalence in certain segments of the population have remained flat—particularly those with lower socioeconomic status, ethnic minorities, and mental health issues. 

CURRENT TREATMENT STRATEGIES

Tobacco dependence treatment is based on the “five A’s” model (ask, advise, assess, assist, and arrange) for all patients at all clinical visits. Clinicians are encouraged to refer patients to nationally available and evidence-based free quit-lines, available through a single portal (1-800-QUITNOW) that links callers to their state quit-line. Cessation guidelines include additional recommendations for brief treatment, counseling availability, medications—all of which are addressed with increasingly practical, efficient, and time-saving procedures that are rooted in scientific evidence, and can be directly addressed by use of telephone quit-lines as a primary treatment referral option. Telephone quit-lines are effective in providing extensive access to behavioral counseling as extenders to brief counseling by clinicians, and some provide nicotine replacement therapy, sometimes at no cost to the smoker. Telephone quit-lines also generally have associated websites with a range of interactive features and resources.

Clinicians are also encouraged to refer patients to www.smokefree.gov, which provides web-based resources including social-media type peer support, behavioral strategies, medication information, and free automated text messaging for cessation. This Web Assisted Tobacco Intervention approach continues to demonstrate promising results in various clinical trials, and constantly evolving technology leads to increased access to support.

There are seven FDA-approved frontline medications, five of which include medicinal nicotine: the patch, gum, lozenge, inhaler, and spray. The two nonnicotine medications are Zyban (bupropion; GlaxoSmithKline) and Chantix (varenicline; Pfizer). With the exception of varenicline (a nicotine agonist), the CDC clearly outlined strategies for combination therapy—the combination of two nicotine replacement medicines, or the combination of one nicotine replacement therapy with bupropion. 

Thanks to evidence from a large clinical trial published in The Lancet (2016; 387: 10037: 2507-2520), varenicline recently had its black box warning removed by the FDA. The study found no significant increases in neuropsychiatric adverse events attributable to varenicline or bupropion relative to nicotine patch or placebo. Varenicline was found to be more effective than placebo, nicotine patch, and bupropion, while bupropion and nicotine patch were more effective than placebo.  

PROMISING STRATEGIES

Combining systematic screening (Asking) with clinical advice (Advice) and then referring them to evidence-based treatment (Assist) is important to have established in medical and behavioral health care systems and, increasingly, as part of the electronic health record (EHR). EHRs remind clinicians to document smoking status, deliver brief advice, prompt for prescription of cessation medications, and facilitate referrals to counseling. As technology continues to advance, such digital options will become even more available, routine, and time-saving.

New nicotine “vaping” and other noncombustible products continue to appear, often with purported claims of safety or reduced risk. Such devices do not require combustion for nicotine delivery. Instead, nicotine and other components are aerosolized for inhalation. E-cigarettes are a popular subset of the broader category of electronic nicotine delivery systems (ENDS) that also include second- and third-generation vaping devices, e-cigars, e-pipes, e-pens, and e-hookahs. 

Research shows that these products are more than just “water vapor” and pose serious risks to human bodily systems. They additionally may expose nonusers to nicotine and a wide range of toxicants through second- and third-hand vapor. Toxicants and potential toxicants arise from the nicotine, but also independently from the flavorings and other (as yet unregulated) product components. To date, e-cigarettes have not been shown to demonstrably increase cessation rates relative to other interventions. Although some experts, globally, point out that ENDS represent a much “safer” alternative to combustible cigarettes, ENDS threaten cessation and/or significant harm reduction on several fronts, and raise concerns about uptake by youth, according to the recent Surgeon General’s report published by the US Department of Health and Human Services (2016), including potential harm associated with long-term use in smokers who switch and continue using ENDS, substituting switching to ENDS (questionable risk) to quitting tobacco products completely (no risk), and dual product use. Until or unless there is FDA regulation and stronger evidence for cessation benefits and/or significant long-term population harm reduction, the potential threat of these products to public health remains.  

A goal of Healthy People 2020 is decreasing barriers to access health care. One of the objectives addresses smoking cessation: AHS-7. This objective seeks to “increase the proportion of persons who receive appropriate evidence-based clinical preventive services.” Many objectives have been directly addressed by the Affordable Care Act, particularly increasing the number of those who are insured. Repeal or substantial change to the Affordable Care Act could translate to loss of health care for many by substantially decreasing access to the treatment options currently available in medical health care and behavioral health care settings; particularly for persons with less than high school educations, who live below the poverty line, and/or who have mental health issues. These groups not only have among the highest smoking rates in the country, and have demonstrated significant disparities in terms of observed declines in smoking, but have historically had less access to health care systems because of being without insurance or being underinsured. Also within these groups are higher proportions of African Americans and Hispanics; racial/ethnic groups that have also had both higher prevalence of smoking historically (compared to whites) and a lower observed decline in smoking. Furthermore, substantial decreases in NIH funding could also threaten the advancement of scientific research to develop better treatments. 

KEEPING AN EYE ON THE PRIZE

The recent Surgeon General’s report published by the HHS noted that important strides have been made over the past several decades in reducing conventional cigarette smoking among youth and young adults, and that we must make sure this progress is not compromised by the initiation and use of new tobacco products, such as e-cigarettes. Despite decreases in overall prevalence, keeping an eye on the prize means eliminating the threat of nicotine dependence despite the range of “differently deadly” products, reductions in access to treatment, and threats to the advancement of science.