Smoking Cessation Strategies in 2017

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Smoking Cessation Strategies in 2017 Robert Schilz DO, PhD, FCCP Division of Pulmonary, Critical Care and Sleep Medicine Director of Lug Transplantation University Hospitals of Cleveland Case Western University School of Medicine

Disclosures I have no disclosures relevant to smoking cessation.

Objectives Examine current smoking trends in the United States Review special concerns of smoking and smoking cessation in the setting of psychiatric disease Discuss currently available strategies for smoking cessation Discuss the relationship between VAPE and smoking (cessation)

Current smoking trends in the United States

https://www.cdc.gov/tobacco/infographics/adult/images/adult-smoking.jpg?s_

Tobacco Use Decreasing, e-cigarettes Increasing Among Middle and High School Students United States, 2011 2014 American Lung Association Adapted from MMWR April 17, 2015 / 64(14);381-385

Special special concerns of smoking and smoking cessation in the setting of psychiatric disease

Adults with Mental Illness or Substance Use Disorder Account for 40% of All Cigarettes Smoked 1 1 Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality (Feb. 5, 2013) The NSDUH Report: Smoking and mental illness. Rockville, MD

Myths of Smoking Cessation in Psychiatric Disease The patients are not interested in quitting. They cannot quit. Quitting interferes with recovery from mental illness or addictions. Tobacco is not as harmful as other substances. Tobacco is necessary for self-medication and tobacco cessation would be too stressful. Tobacco cessation efforts might prevent treatment of other addictions. CDC Best Practices User Guide:Health Equity in Tobacco Prevention and Control 2015 Prochaska JJ NEJM 2011;365:196-198

Binding of nicotine to nach receptors in Ventral Tegmental Area and Nucleus Accumbens Augments Dopamine Based Reward/Addiction Pathways

Current Illicit Drug and Alcohol Use Among Adult Cigarette Smokers Compared with Non-Smokers Substance Abuse and Mental Health Services Administration. Results from the 2013 National Survey on Drug Use and Health: Detailed Tables, Tables 6.10B and 6.24B. Rockville, MD: Substance Abuse and Mental health Services Administration, Center for Behavioral Health Statistics and Quality, 2014

Change in mental health after smoking cessation: systematic review and meta-analysis

Difference between change in mental health outcomes (anxiety, mixed anxiety and depression, depression, stress) from baseline to longest follow-up in people who stopped smoking or continued to smoke. Gemma Taylor et al. BMJ 2014;348:bmj.g1151

Difference between change in mental health outcomes (positive affect, psychological quality of life) from baseline to longest follow-up in people who stopped smoking or continued to smoke. Gemma Taylor et al. BMJ 2014;348:bmj.g1151

Conclusions Smoking cessation is associated with reduced depression, anxiety, and stress and improved positive mood and quality of life compared with continuing to smoke. The effect size seems as large for those with psychiatric disorders as those without. The effect sizes are equal or larger than those of antidepressant treatment for mood and anxiety disorders

Varinecline, Bruproprion and Nicotine Drug Interactions Buproprion Nicotine hypertension Many DDI importantly promoting seizure activity Nicotine Buproprion hypertension (6% vs 3.1% placebo) Varinecline -partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes DDI abacavir / dolutegravir / lamivudine, dolutegravir, ethanol, nicotine, ranolazine, vandetanib, insulin, coumadin, theophylline Repeal of FDA Warning The first study included 14,131 Chantix users and an equal number of NRT users. Sixteen psychiatric hospitalizations occurred among Chantix-treated patients, and 21 occurred among NRT patients (hazard ratio [HR], 0.76). The second study compared the acute (30-day) rates of hospitalizations for neuropsychiatric adverse events among new users of Chantix (n = 19,933) or the NRT patch (n = 15,867) who started therapy from August 2006 to August 2007 in the Military Health System. Similar to the previous study, 18 psychiatric hospitalizations occurred among Chantix users, and 16 occurred among NRT users (HR, 1.13).

Morris C et al. Updated January 2009 Smoking Cessation for Persons with Mental Illnesses http://www.integration.samhsa.gov%2fsmoking_cessation_for_persons_with_mi.pdf

Smoking Cessation

Facts About Smoking Cessation Approximately 46 percent of active smokers try to quit each year. Most try to quit cold turkey. Of those, only about 5 percent succeed. Most smokers make several quit attempts before they successfully quit for good.

US Smoking Cessation Trends 2010-2015 http://www.cdc.gov

PHS Model for Treating Tobacco Use and Dependence General population Patient presents to a health care setting (clinic, hospital, work site, others) Relapse Ask screen all patients for tobacco use Chapter 2 Current users Advise to Quit Chapter 3A Assess willingness to quit Chapter 3A Yes Assist with quitting Chapter 3A Chapter 4 Arrange followup Chapter 3A Never users Primary prevention Former users No Promote motivation to quit Chapter 3B Patient now willing to quit Abstinent Prevent relapse Chapter 3C Patient remains unwilling US Public Health Service 2009

Patients Not Ready To Make A Quit Attempt Now (The 5 R s ) Relevance Encourage the patient to indicate why quitting is personally relevant. Risks Ask the patient to identify potential negative consequences of tobacco use. Rewards Ask the patient to identify potential benefits of stopping tobacco use. Roadblocks Ask the patient to identify barriers or impediments to quitting. Repetition The motivational intervention should be repeated every time an unmotivated patient has an interaction with a clinician. Tobacco users who have failed in previous quit attempts should be told that most people make repeated quit attempts before they are successful.

Smith et al. BMC Public Health (2017) 17:430 Smokers Perspective - Process

Developing a Plan for Smoking Cessation Among Patients Motivated to Quit STAR Set a quit date. Ideally, the quit date should be within 2 weeks. Tell family, friends, and coworkers about quitting, and request understanding and support. Anticipate challenges to the upcoming quit attempt, particularly during the critical first few weeks. These include nicotine withdrawal symptoms. Remove tobacco products from your environment. Prior to quitting, avoid smoking in places where you spend a lot of time (e.g., work, home, car). Make your home smoke-free. Tobacco Use and Dependence Guideline Panel. Rockville (MD): US Department of Health and Human Services; 2008 May.

Pharmacologic Therapy for Smoking Cessation: How Do We Pick? Approved Agents First-Line Long Acting (Patch) + Short Acting Lozenge, gum, inhaler, nasal spray Buproprion Second Line Buroprion + Combination NRT Varinecline + Combination NRT Third Line Buroprion + Varinecline + Combination NRT Nortriptyline Clonidine Experimental Approaches Anti-nicotine vaccines Naltrexone Cytisine

Meta-Analyses of Pharmacotherapy

Assessing Risk for Relapse Degrees of Nicotine Dependence Presence of Withdrawal Symptoms Number of Previous Failed Attempts Behavior in Early Phases of Cessation

Van Zyl-Smit RN et al. S Af Med J 2013 103(11):869-876

Fagerström Test for Nicotine Addiction

Inverse Relationship of Abstinence to Nicotine Addiction Scores Tervonen et al. BMC Public Health (2017) 17:331

Patterns of Early Abstinence in Smoking Cessation Studies Predict Cessation Success 3 Month Abstinence Rates by Latent Class 60 50 40 30 20 10 0 Early Quitters Early Intermittent Smokers Late Intermittent Smokers Relapsers Cessation Failures Study 1 Study 2 Study 3 Pooled Studies 1-3 McCarthy et al. Drug and Alcohol Dependence (2016) 165:132-142

3 Month Abstinence Rates Combining Varinecline and Buproprion in Patients with < 50% First Week Decrease in Smoking Using NRT Alone Rose and Behm Am J Psychiatry. 2014 Nov 1; 171(11): 1199 1205.

USPTF Guidelines on Counselling and Smoking Cessation Intensity/Frequency Both minimal (<20 min in 1 visit) and intensive ( 20 min plus >1 follow-up visit) physician-advice interventions effectively increase the proportion of adults who successfully quit smoking and remain abstinent for 6 mo. There is a dose response relationship between the intensity of counseling and cessation rates (i.e., more or longer sessions improve cessation rates). Multiple sessions should be provided; according to the Public Health Service guidelines, patients should receive 4 in-person counseling sessions. Cessation rates may plateau after 90 min of total counseling contact time. Duration Brief, in-person behavioral counseling sessions (<10 min) effectively increase the proportion of adults who successfully quit smoking and remain abstinent for 1 y. Although less effective than longer interventions, even minimal interventions (<3 min) have been found to increase cessation rates in some studies. Format In-person behavioral counseling sessions (individual or group counseling) Telephone counseling Tailored, print-based self-help materials *Mobile device apps Adapted from Final Recommendation Statement: Tobacco Smoking Cessation in Adults, Including Pregnant Women: Behavioral and Pharmacotherapy Interventions. U.S. Preventive Services Task Force. September 2017 *Not part of USPTF statement

Suggestion of Approach to Smoking Cessation Screen for Risk Advise to Quit Assess Willingness Willing Arrange 1) Counselling 2) Pharmacotherapy Unwilling *Assess Addiction 5 R s 1 st, 2 nd or 3 rd Line Pharmacotherapy Based on Risk *Assess Early Relapse If on NRT only, consider Buproprion + Varinecline Reassess Recent Quitters

NCCN Guidelines Version 1.2015 Smoking Cessation, 2015.

Use of ENDS Electronic Nicotine Delivery Systems (VAPING) and Smoking Cessation

The USPSTF concludes that the current evidence on the use of ENDS for conventional smoking cessation is insufficient. Evidence is lacking and conflicting, and the balance of benefits and harms cannot be determined. Given the established safety and effectiveness of behavioral and pharmacotherapy interventions, the USPSTF recommends that primary care providers direct patients who smoke to these other interventions. Final Recommendation Statement: Tobacco Smoking Cessation in Adults, Including Pregnant Women: Behavioral and Pharmacotherapy Interventions. U.S. Preventive Services Task Force. September 2017

Overview of Literature on ENDS and Smoking Cessation 820 MEDLINE publications on Smoking Cessation + Electronic Cigarettes. (Both topics exploded and combined) 3 Randomized, Controlled Trials 1 of 3 enrolled patients that we not interested in quitting (Adriaens et al. Int Environ Res Public Health 2014 11:11220-48.) Only 1 trial compared to NRT patches only.

Comparison of NRT and ENDS in Smoking Cessation Bullen et al. Lancet 382(9905):1629-1637) 2013.

Meta-analysis of RCTs on cessation smoking comparing ENDS versus ENND. Regina El Dib et al. BMJ Open 2017;7:e012680

From: Behavioral Counseling and Pharmacotherapy Interventions for Tobacco Cessation in Adults, Including Pregnant Women: A Review of Reviews for the U.S. Preventive Services Task Force Ann Intern Med. 2015;163(8):608-621. doi:10.7326/m15-0171

Quit Methods Used by US Adult Cigarette Smokers, 2014 2016 Quit Method Used No. (Weighted %) Reported using multiple quit methods 12,417 (74.7) Gave up cigarettes all at once 10,631 (65.3) Gradually cut back on cigarettes 9,682 (62.0) Substituted some regular cigarettes with e-cigarettes 5,861 (35.3) Used nicotine patch or nicotine gum 4,047 (25.4) Switched completely to e-cigarettes 3,721 (24.7) Switched to mild cigarettes 3,376 (20.4) Got help from a doctor or other health professional 2,963 (15.2) Used FDA-approved medications such as Zyban or Chantix 2,374 (12.2) Got help from a website such as Smokefree.gov 1,146 (7.1) Caraballo RS, Shafer PR, Patel D, Davis KC, McAfee TA. Quit Methods Used by US Adult Cigarette Smokers, 2014 2016. Prev Chronic Dis 2017;14:160600. DOI: http://dx.doi.org/10.5888/pcd14.160600

National Youth Tobacco Survey 2011-15: Trends in ever e-cigarette use among US high school and middle school student

Electronic Cigarettes Increased 1 Year Cigarette Smoking in UK Adolescents Baseline ever e-cigarette use strongly associated with subsequent initiation of cigarette use. (n=1726, OR 5.38 95% CI 4.02-7.22) which remained highly significant when controlling for covariates (OR 4.06) Baseline ever e-cigarette use strongly associated with subsequent escalation of cigarette use. (n=318, OR 1.91, 95% CI 1.14-3.21) which lost statistical significance when corrected for covariates (OR 1.39, 95% CI 0.97-1.82) Connor et al. J Tobacco Control, http://dx.doi.org/10.1136/tobaccocontrol-2016-053539e

Soneji et al. JAMA Pediatrics 171(3): 788-797, 2017. Initial Electronic Cigarette Use is Associated with Increased Subsequent Tobacco Initiation and > 30 Day Use in Adolescents and Young Adults (n=17389 Meta-analysis) 35 Chart Title 30 25 20 15 10 5 0 Smoking Initiation > 30 Day Cigarette Use Never ecig Ecig

Fig 2 Quit attempt rate and annual cessation rate from 2001-02 to 2014-15, USA. CPS- TUS=Current Population Survey-Tobacco Use Supplement. Shu-Hong Zhu et al. BMJ 2017;358:bmj.j3262 2017 by British Medical Journal Publishing Group

Fig 1 Quit attempt rate and annual cessation rate by e-cigarette use status, 2014-15, USA. CPS- TUS=Current Population Survey-Tobacco Use Supplement. Shu-Hong Zhu et al. BMJ 2017;358:bmj.j3262 2017 by British Medical Journal Publishing Group

Summary Post Test Examine current smoking trends in the United States Is the absolute number of smokers increasing or decreasing? Name high risk groups Review special concerns of smoking and smoking cessation in the setting of psychiatric disease Myths? Recommendations? Discuss currently available strategies for smoking cessation Counselling Behavioral Pharmacologic Discuss the relationship between VAPE and smoking (cessation) Are ENDS recommended or approved for smoking cessation? What are current trends of adolescent ENDS use?