9/28/2017. Nicotine Addiction : Past, Present and Future. How to Use this Tutorial. Something to Think About

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1 Nicotine Addiction : Past, Present and Future Robert W. Murphy PharmD, BCPS St. Vincent Evansville Date How to Use this Tutorial Introduction History Clinical pharmacology of nicotine Pharmacotherapy of nicotine elimination A brief clinical intervention The science of behavior change Practical application of strategies into your practice 2 Something to Think About Does it just take will power to stop smoking? When was nicotine established as lethal? When was cancer first reported with tobacco? Is smoking a pediatric issue? How can you help a person change his or her behavior? Would you consider taking a drug which would reliably Increase your memory? Increase your performance in tasks? Decrease your weight? 3 1

2 Objectives Review the history and epidemiology of tobacco use Review the clinical pharmacology of nicotine Review clinical use of smoking cessation products Review the science behind human behavior Learn strategies to help facilitate behavior changes to quit smoking 4 5 Guideline Recommendations Tobacco dependence is a chronic condition that often requires repeated intervention However, effective treatments exist that can produce long-term or even permanent abstinence 6 2

3 Guideline Recommendations Because effective treatments are available, every patient who uses should be offered at least one of these treatments: Patients willing to try and quit should be provided with treatments identified as effective Patients unwilling to try and quit should be provided with a brief intervention designed to increase their motivation to quit There is a strong dose-response relationship between the intensity of counseling and its effectiveness 7 Guideline Recommendations Three types of counseling have been found especially effective: Problem solving and skills training Social support within treatment Social support outside of treatment 8 Guideline Recommendations Except in the absence of contraindications one of the following pharmacotherapies should be used in all patients attempting to quit smoking Bupropion SR Nicotine Gum Nicotine Inhaler Nicotine patch Nicotine lozenge Varenicline Tobacco dependence treatments are both Clinically Effective and Cost-effective relative to other medical and disease prevention interventions 9 3

4 A Brief History of Nicotine and Smoking What would you do to smoke?

5 History of Tobacco 13 History of Tobacco 14 History of Tobacco 15 5

6 Tobacco Marketing 16 Tobacco Marketing 17 Tobacco Marketing Cigarette and smokeless tobacco companies spend billions of dollars each year to market their products: In 2014, cigarette and smokeless tobacco companies spent more than $9 billion on advertising and promotional expenses in the United States alone. Cigarette companies spent approximately $8.49 billion on cigarette advertising and promotion in 2014, down from $8.95 billion in The five major U.S. smokeless tobacco manufacturers spent $600.8 million on smokeless tobacco advertising and promotion in 2014, an increase from $503.2 million spent in 2013 The money cigarette and smokeless tobacco companies spent in 2014 on U.S. marketing amounted to : Nearly $25 million each day. More than $28 for every person (adults and children) in the United States per year (according to 2014 population estimate of 320,000,000). More than $227 per year for each U.S. adult smoker (based on 40 million adult smokers in 2014). 18 6

7 Epidemiology of Smoking Smoking Related Disease and Death 20 Smoking Related Disease and Death 21 7

8 Smoking Related Disease and Death Accounts for 30% of all cancer deaths, specifically 80-90% of all lung cancers Also associated with laryngeal, oral, pharyngeal, esophageal, kidney and bladder cancer 20% of all CV deaths are attributable to smoking Cigarette smoking accelerates atherosclerosis and promotes ischemic events Risk of mortality from ischemic heart disease is 15 x higher than in nonsmokers Reproductive disturbances fertility issues, premature birth, and lower birthweight. 22 Smoking Related Disease and Death Major cause of chronic bronchitis and emphysema. 80% of deaths are attributable to smoking Increased risk of gastric/duodenal cancer 20% of all CV deaths are attributable to smoking Smoking accounts for 15% of all stroke deaths annually. Overall RR is 1.5X with smoking Female smokers > 35y/o + use of oral contraceptives = increased risk of stroke Miscellaneous: premature facial wrinkling, increased risk of osteoporosis in both genders and increased risk of sexual dysfunction in men 23 A Decline in US smoking 24 8

9 What compounds are in a cigarette 25 Compound Quiz, Match Column A with Column B 26 Smoking Statistics 27 9

10 Smoking Statistics 28 Smoking Statistics 29 Indiana Tobacco Burden Smoking costs Hoosiers $2.93 billion in tobacco-related medical costs. Nearly $590 million of these expenditures are covered by Medicaid. For every pack of cigarettes sold in Indiana, our state spends $15.90 in health care costs and lost productivity. 11,100 Hoosiers die each year from tobacco 31 Hoosiers die each day from tobacco 1 Hoosier dies every hour from tobacco 30 10

11 Secondhand Smoke (ETS) : Fact or Fiction Surgeon General s Report, 1986 Involuntary smoking is a cause of disease, including lung cancer, in healthy nonsmokers. Simple separation of smokers/nonsmokers does not eliminate exposure to ETS Children of parents who smoke have increased frequency of respiratory illnesses 31 Secondhand Smoke (ETS) NIOSH Report, 1991 ETS poses an increased risk of lung cancer and, possibly, heart disease to people exposed in the workplace Recommends that nonsmokers should not be exposed to secondhand smoke 2 methods by which nonsmokers can be protected : complete elimination of smoking in the building or establishment of separate, enclosed smoking areas that are separately ventilated and directly exhausted to the outside 32 Health Burden of Tobacco 33 11

12 Health Burden of Tobacco 34 Health Burden of Tobacco 35 Destructive effects of Tobacco Cigarette smoking is responsible for more than 480,000 deaths per year in the United States, including more than 41,000 deaths resulting from secondhand smoke exposure. This is about one in five deaths annually, or 1,300 deaths every day It is estimated that secondhand smoke caused nearly 34,000 heart disease deaths each year during among adult nonsmokers in the United States. Secondhand smoke exposure caused more than 7,300 lung cancer deaths each year during among adult nonsmokers in the United States. Smoking causes more deaths each year than the following causes combined: Human immunodeficiency virus (HIV), Illegal drug use, Alcohol use, Motor vehicle injuries, and Firearm-related incidents 36 12

13 37 Pharmacology of Nicotine Nicotine Pharmacology 39 13

14 Nicotine Pharmacology 40 Nicotine Pharmacology 41 Nicotine Pharmacology 42 14

15 Addiction to Nicotine Nicotine Addiction 44 Nicotine Addiction 45 15

16 46 Nicotine Addiction 47 Nicotine Addiction 48 16

17 Nicotine Addiction 49 Nicotine Addiction 50 Nicotine Addiction 51 17

18 52 Pharmacotherapy of Smoking Nicotine Absorption 54 18

19 Nicotine Absorption 55 Nicotine Absorption 56 Nicotine Absorption 57 19

20 58 Bupropion SR Atypical antidepressant thought to affect levels of various brain neurotransmitters specifically dopamine and norepinephrine Clinical effects translate to decreased craving for cigarettes and decreased symptoms of nicotine withdrawal 59 Characteristics of the main double blind RCT of bupropion SR in smoking cessation Study Date Number randomiz ed Participants characteristics Setting Hurt Healthy smokers 3 centers in US Jorenby Healthy smokers Community based Gonzales Previously failed with bupropion 16 centers in US Bupropion treatment 300 mg daily 7 weeks 150 mg bid 9 weeks 150 mg bid 12 weeks 12-month cessation rate: bupropion % vs placebo % (p) 23 vs 12 (0.01) 30 vs 16 (<0.001) Discontinuati on due to adverse events %; bupropion vs placebo 8 vs 5 12 vs 4 12 vs 2 (<0.001) a 8 vs 5 Tashkin Patients with established COPD 11 centers in 150 mg bid US 12 weeks 16 vs 9 (0.05) a 7 vs 7 Tonstad Patients with established CVD 28 centers mg bid 7 22 vs 9 countries weeks (<0.001) 5 vs 6 Ahluwalia Healthy African American smokers Community based 150 mg bid 7 weeks 21 vs 14 (0.02) a Tonneson Healthy smokers 26 centers mg bid 7 21 vs 11 countries weeks (0.002) 8 vs 6 Dalsgareth Healthy Danish smokers Hospital staff 5 hospitals Aubin Healthy French smokers Community based Zellweger Healthy nurses and physicians 26 centers 12 countries 150 mg bid 7 weeks 150 mg bid 7 weeks 150 mg bid 7 weeks 18 vs 7 (0.008) a 12 vs 8 25 vs 13 (<0.001) a 10 vs 5 23 vs 22 (NS) b 9 vs

21 Bupropion SR 61 Bupropion SR

22 Varenicline (Chantix ) 64 Varenicline (Chantix ) 65 Varenicline (Chantix )- Warnings Neuropsychiatric sx s and suicide risk Changes in mood (including depression and mania) Psychosis/hallucinations/paranoia/delusions Homicidal ideation Aggression/hostility/anxiety/panic Seizures and accidental injury Enhanced effects of alcohol Allergic type reactions 66 22

23 Varenicline (Chantix ) 67 Varenicline (Chantix ) 68 Nicotine Replacement Therapy 69 23

24 Nicotine Replacement Therapy 70 Nicotine Replacement Therapy 71 Nicotine Replacement Therapy 72 24

25 Nicotine Replacement Therapy 73 Nicotine Replacement Therapy 74 Nicotine Replacement Therapy 75 25

26 Nicotine Replacement Therapy 76 Nicotine Replacement Therapy 77 Nicotine Replacement Therapy 78 26

27 Nicotine Replacement Therapy 79 Nicotine Replacement Therapy 80 Nicotine Replacement Therapy 81 27

28 Nicotine Replacement Therapy 82 Nicotine Replacement Therapy 83 Nicotine Replacement Therapy 84 28

29 Nicotine Replacement Therapy 85 Nicotine Replacement Therapy 86 Nicotine Replacement Therapy 87 29

30 Nicotine Replacement Therapy 88 Nicotine Replacement Therapy 89 Nicotine Replacement Therapy 90 30

31 Commit lozenge basics Lozenge contains 2 or 4 mg of nicotine as nicotine polacrilex resin Completely dissolves and thus releases all of its nicotine Strength based on time of first cigarette Use 2mg if patient smokes their first cigarette more than thirty (30) minutes after first arising in the morning Use 4mg if patient smokes first cigarette less than thirty (30) minutes after arising in the morning Adverse Events Most AE were mild and not serious, < 10% led to discontinuation. AE s with incidence active > placebo: 2mg/4mg: 4mg only: naus,hiccup,heartburn headache, coughing 31

32 Lozenge use instructions During the 1 st 6 weeks, take 1 lozenge every 1 to 2 hours. Use at least 9 per day. In weeks 7 to 9, take one lozenge every 2-4 hours. In weeks take 1 lozenge every 4-8 hours, gradually using less and less. Stop using Commit at the end of 12 weeks. How to Use Commit Properly Avoid food and beverage 15 minutes before and during use of Commit Place Commit in your mouth and allow the lozenge to dissolve slowly (about minutes). Move the lozenge from one side of the mouth to the other until dissolved. Use no more than 20 lozenges per day. Combination Pharmacotherapy Dual NRT therapy Long acting formulation (patch) plus short-acting formulation (gum, inhaler, nasal spray) Bupropion SR plus Nicotine Patch (FDA approved) Combination NRT significantly increased long-term ( 6 months) smoking abstinence rates compared to single NRT or no NRT (Risk ratio 1.35; 95% CI: ) 96 32

33 Meta-Analysis for Treatment Options 97 Nicotine Adverse Effects 98 Changing Behavior A Brief Intervention 33

34 Behavioral Modification 100 Behavioral Modification 101 Behavioral Modification

35 Behavioral Modification 103 Behavioral Modification 104 Behavioral Modification

36 Behavioral Modification 106 Behavioral Modification 107 Behavioral Modification

37 Behavioral Modification 109 Behavioral Modification 110 Behavioral Modification

38 Behavioral Modification 112 Behavioral Modification 113 Behavioral Modification

39 Behavioral Modification 115 Behavioral Modification 116 Behavioral Modification

40 Behavioral Modification 118 Relapse 119 Relapse Smoking cessation is a process, not a one shot deal Relapse is common to the process of quitting smoking and should not be seen as a sign of failure, but instead a rehearsal for the next quitting attempt. 65% of smokers who quit smoking relapse within three months of quitting Another 10% relapse in three to six months after quitting Many individuals quit three to four times before stopping for good The key to being successful is learning to identify the behaviors associated with smoking and learning how to change these behaviors to become smoke free

41 Understanding the process of change

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45 Tips for Quitting Smoking Don t stock up on a cigarette supply After feeling the urge to smoke a cigarette, wait and ask yourself why you need this cigarette Make a list of things you could treat yourself to if you used the money you would save from giving up cigarettes When you go to public restaurants sit in nonsmoking sections List reasons why to quit, every night before bedtime, and read this list each morning as soon as you get up Keep a diary and record each time you have the urge to smoke, and record each cigarette you give up

46 Why You should Stop Smoking It is estimated that smoking causes more deaths in the United States each year than alcohol, illicit drug use, car accidents, fires, suicide, and homicide combined Smoking is the single most preventable cause of death in this country In the US smoking accounts for approximately 1 in 6 deaths Children whose parents smoke are at a higher risk for respiratory and middle ear infections than those whose parents do not smoke Smoking is a learned behavior that can be unlearned with appropriate counseling, information, and coping skills Saving money Quitting is not easy, but it is not impossible More than 3 million Americans quit smoking every year Financial Impact of Smoking 137 Learning How to Cope Create a survival kit which can include: A. Phone number of a nonsmoking friend B. Low fat snacks or gum to keep the mouth busy C. Deck of cards to keep your hands busy D. A list of reasons why you want to quit smoking E. Put money in there that you would have spent on cigarettes 2. Other hints A. Discard any cigarettes in your house or purse B. Get rid of ashtrays, lighters, matches C. Learn and plan other ways to relieve stress (i.e., exercise, relaxation techniques) 3. Learn to view your quitting smoking as a freedom and learn to feel in control 4. Realize the possibility of relapse, and the fact that it is not a sign of failure. It is a setback, but you can learn from the temptation and learn how to avoid relapse in the future. 5. If you tend to smoke when you drive or when you drink a cup of coffee, learn to substitute behaviors. 6. Keep in mind your goals, and each day will be easier than the last. 46

47 Electronic Cigarettes 139 Electronic Cigarettes How an E-cigarette Works E-cigarettes create an aerosol by using a battery to heat up liquid that usually contains nicotine, flavorings, and other additives. Users inhale this aerosol into their lungs. E-cigarettes can also be used to deliver cannabinoids such as marijuana, and other drugs. Battery powers the device Atomizer heats the e-liquid into an aerosol Cartridge stores the e-liquid Mouthpiece allows the user to inhale the aerosol 140 Electronic Cigarettes Nicotine emission is determined in large part by three factors 1. The device s electrical power output (measured in watts or W) 2. Liquid nicotine concentrations 3. User behavior (i.e. puff number and duration) Early models delivered little nicotine to the user; however, more sophisticated devices can now match the nicotine delivery of a tobacco cigarette

48 Electronic Cigarettes 142 Electronic Cigarettes 143 Electronic Cigarettes E-cigarettes are a 2.5 billion dollar business As of 2014, e-cigarette industry spent $125 million to advertise their products. Constituents of Secondhand aerosol 1) Nicotine 2) Ultrafine Particles may exacerbate respiratory ailments 3) Low levels of toxins benzene, acrolein, formaldehyde and others. 4) Propylene glycol 5) Heavy metals chromium, nickel and tin

49 Electronic Cigarettes FDA guidance This new rule builds on groundwork that was set close to seven years ago. The FDA has regulated cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco products since June 2009, after Congress passed and the President signed the Family Smoking Prevention and Tobacco Control Act. This Act gave the agency authority to regulate the manufacturing, distribution, and marketing of tobacco products. It extends the FDA s regulatory authority to all tobacco products, including e- cigarettes which are also called electronic cigarettes or electronic nicotine delivery systems (ENDS) all cigars (including premium ones), hookah (also called waterpipe tobacco), pipe tobacco, nicotine gels, and dissolvables that did not previously fall under the FDA s authority. It requires health warnings on roll-your-own tobacco, cigarette tobacco, and certain newly regulated tobacco products and also bans free samples. In addition, because of the rule, manufacturers of newly regulated tobacco products that were not on the market as of February 15, 2007, will have to show that products meet the applicable public health standard set by the law. And those manufacturers will have to receive marketing authorization from the FDA. The new rule also restricts youth access to newly regulated tobacco products by: 1) not allowing products to be sold to those younger than 18 and requiring age verification via photo ID; and 2) not allowing tobacco products to be sold in vending machines (unless in an adult-only facility). 145 Additional Resources Indiana s Tobacco Quitline QUIT-NOW For providers and employers, new way to enroll tobacco users in the Indiana Tobacco Quitline