5,000. China 35.6 (66.9/4.2) Number of cigarettes 4,000. Japan 33.1 (52.8/13.4) 3,000. Philippines 32.4 (53.8/11.0) 2,000 1,000

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1 TRAINING OVERVIEW Rx for CHANGE Clinician-Assisted Tobacco Cessation Epidemiology of Tobacco Use module Nicotine Pharmacology & Principles of Addiction module Drug Interactions with Smoking module Assisting Patients with Quitting module Hands-on workshop Aids for Cessation module Tobacco trigger tapes Case scenarios EPIDEMIOLOGY of TOBACCO USE CIGARETTE SMOKING is the chief, single, avoidable cause of death in our society and the most important public health issue of our time. C. Everett Koop, M.D., former U.S. Surgeon General USA 20.9 (23.9/18.1) Canada 25.0 (27.0/23.0) Brazil 33.8 (38.2/29.3) WORLDWIDE ADULT TOBACCO USE PREVALENCE (Men/Women) UK 26.5 (27.0/26.0) Guinea 51.7 (59.5/43.8) France 34.5 (38.6/30.3) Namibia 50.0 (65.0/35.0) Sweden 19.0 (19.0/19.0) Yugoslavia 47.0 (52.0/42.0) Iran 15.3 (27.2/3.4) India 16.0 (29.4/2.5) Australia 19.5 (21.1/18.0) Russian Federation 36.5 (63.2/9.7) China 35.6 (66.9/4.2) Japan 33.1 (52.8/13.4) Philippines 32.4 (53.8/11.0) South Africa 26.5 (42.0/11.0) New Zealand 25.0 (25.0/25.0) Mackay & Erickson. (2002). The Tobacco Atlas. World Health Organization. Number of cigarettes TRENDS in ADULT CIGARETTE CONSUMPTION U.S., Annual adult per capita cigarette consumption and major smoking and health events 5,000 4,000 3,000 2,000 1,000 0 U.S. entry into WW I Great Depression End of WW II 1964 Surgeon General s Report Marketing of filtered cigarettes First modern reports linking smoking and cancer Nonsmokers rights movement begins Broadcast ad ban Federal cigarette tax doubles Master Settlement Agreement; California first state to enact ban on smoking in bars Cigarette price drop Year Centers for Disease Control and Prevention. (1999). MMWR 48: Per-capita updates from U.S. Department of Agriculture, provided by the American Cancer Society. 20 states have > $1 pack tax 1

2 Pounds of tobacco per capita ADULT PER-CAPITA CONSUMPTION of TOBACCO, Snuff Chewing tobacco Cigars Pipe/roll your own Cigarettes All forms of tobacco are harmful Year Adapted from NCI Smoking and Tobacco Control Monograph 8, 1997, p. 13. Data from U.S. Department of Agriculture. Reprinted with permission. Thun et al Oncogene 21: Percent TRENDS in ADULT SMOKING, by SEX U.S., Trends in cigarette current smoking among persons aged 18 or older Male Female 23.9% 18.1% Year 70% want to quit 20.9% of adults are current smokers Graph provided by the Centers for Disease Control and Prevention Current Population Survey; NHIS. Estimates since 1992 include some-day smoking. California 15.2% STATE-SPECIFIC PREVALENCE of SMOKING among ADULTS, 2005 Illinois 19.9% Kentucky 28.7% PREVALENCE of ADULT SMOKING, by RACE/ETHNICITY U.S., % American Indian/Alaska Native* 21.9% White* Nevada 23.1% Utah 11.5% Texas 20.0% Indiana 27.3% New York 20.5% Florida 21.6% 21.5% Black* 16.2% Hispanic 13.3% Asian* 0% 10% 20% 30% 40% 50% * non-hispanic. Centers for Disease Control and Prevention. (2006). MMWR 55: Centers for Disease Control and Prevention. (2006). MMWR 55: PREVALENCE of ADULT SMOKING, by EDUCATION U.S., 2005 TRENDS in TEEN SMOKING, by ETHNICITY U.S., % No high school diploma 43.2% GED diploma 24.6% High school graduate 22.5% Some college 10.7% Undergraduate degree Percent Trends in cigarette smoking among 12th graders: 30-day prevalence of use White Hispanic Black 0% 10% 20% 30% 40% 50% 7.1% Graduate degree Centers for Disease Control and Prevention. (2006). MMWR 55: Year Institute for Social Research, University of Michigan, Monitoring the Future Project 2

3 PUBLIC HEALTH versus BIG TOBACCO The biggest opponent to tobacco control efforts is the tobacco industry itself. The TOBACCO INDUSTRY For decades, the tobacco industry has publicly denied the addictive nature of nicotine and the negative health effects of tobacco. April 14, 1994: Seven top executives of major tobacco companies state, under oath, that they believe nicotine is not addictive. Tobacco industry documents suggest otherwise Documents available at In the U.S., for every $1 spent on tobacco prevention, the tobacco industry spends $28 to market its products. The cigarette is a heavily engineered product. Designed and marketed to maximize bioavailability of nicotine and addictive potential Profits over people An EFFECTIVE MARKETING STRATEGY: LIGHT CIGARETTES The difference between Marlboro and Marlboro Lights TOBACCO INDUSTRY ADVERTISING $15.15 billion spent in the U.S. in % increase over 2002 figures 35.0% increase over 2001 figures an extra row of ventilation holes Billions of dollars spent Image courtesy of Mayo Clinic Nicotine Dependence Center - Research Program / Dr. Richard D. Hurt Year The Marlboro and Marlboro Lights logos are registered trademarks of Philip Morris USA. Federal Trade Commission. (2005). Cigarette Report for ANNUAL U.S. DEATHS ATTRIBUTABLE to SMOKING, ANNUAL SMOKING-ATTRIBUTABLE ECONOMIC COSTS U.S., Cardiovascular diseases Lung cancer Respiratory diseases Second-hand smoke* Cancers other than lung Other 137, , ,454 38,112 34,693 1,828 Percentage of all smokingattributable deaths* 32% 28% 23% 9% 8% <1% Medical expenditures (1998) Annual lost productivity costs ( ) Ambulatory care, $27.2 billion Men, $55.4 billion Hospital care, $17.1 billion Prescription drugs, $6.4 billion Societal costs: $7.18 per pack Nursing home, $19.4 billion Other care, $5.4 billion Women, $26.5 billion TOTAL: 437,902 deaths annually * In 2005, it was estimated that nearly 50,000 persons died due to second-hand smoke exposure. Centers for Disease Control and Prevention. (2005). MMWR 54: Billions of dollars Centers for Disease Control and Prevention. (2002). MMWR 51:

4 COMPOUNDS in TOBACCO SMOKE An estimated 4,800 compounds in tobacco smoke, including 11 proven human carcinogens Gases Carbon monoxide Hydrogen cyanide Ammonia Benzene Formaldehyde Particles Nicotine Nitrosamines Lead Cadmium Polonium-210 Nicotine does NOT cause the ill health effects of tobacco REPORT of the SURGEON GENERAL: HEALTH CONSEQUENCES OF SMOKING FOUR MAJOR CONCLUSIONS: Smoking harms nearly every organ of the body, causing many diseases and reducing the health of smokers in general. Quitting smoking has immediate as well as long-term benefits, reducing risks for diseases caused by smoking and improving health in general. Smoking cigarettes with lower machine-measured yields of tar and nicotine provides no clear benefit to health. The list of diseases caused by smoking has been expanded. U.S. Department of Health and Human Services. (2004). The Health Consequences of Smoking: A Report of the Surgeon General. HEALTH CONSEQUENCES of SMOKING Cancers Acute myeloid leukemia Bladder and kidney Cervical Esophageal Gastric Laryngeal Lung Oral cavity and pharyngeal Pancreatic Pulmonary diseases Acute (e.g., pneumonia) Chronic (e.g., COPD) Cardiovascular diseases Abdominal aortic aneurysm Coronary heart disease Cerebrovascular disease Peripheral arterial disease Reproductive effects Reduced fertility in women Poor pregnancy outcomes (e.g., low birth weight, preterm delivery) Infant mortality Other effects: cataract, osteoporosis, periodontitis, poor surgical outcomes U.S. Department of Health and Human Services. (2004). The Health Consequences of Smoking: A Report of the Surgeon General REPORT of the SURGEON GENERAL: INVOLUNTARY EXPOSURE to TOBACCO SMOKE Second-hand smoke causes premature death and disease There is no in nonsmokers (children and adults) safe level of Children: second-hand Increased risk for sudden infant death syndrome smoke. (SIDS), acute respiratory infections, ear problems, and more severe asthma Respiratory symptoms and slowed lung growth if parents smoke Adults: Immediate adverse effects on cardiovascular system Increased risk for coronary heart disease and lung cancer Millions of Americans are exposed to smoke in their homes/workplaces Indoor spaces: eliminating smoking fully protects nonsmokers Separating smoking areas, cleaning the air, and ventilation are ineffective USDHHS. (2006). The Health Consequences of Involuntary Exposure to Tobacco Smoke: Report of the Surgeon General. SMOKE-FREE WORKPLACE LAWS Smoke-free offices, restaurants, and bars: California, Colorado, Connecticut, Delaware, Hawaii, Maine, Massachusetts, New Jersey, New York, Rhode Island, Vermont, Washington Smoke-free offices and restaurants: Arkansas, District of Columbia (bars in 2007), Florida, Georgia, Idaho, Louisiana, Montana (bars in 2009), Nevada, North Dakota, Utah (bars in 2009) Smoke-free offices: Maryland, South Dakota Data current as of November 9, Circulation improves, walking becomes easier QUITTING: HEALTH BENEFITS Lung function increases up to 30% Excess risk of CHD decreases to half that of a continuing smoker Lung cancer death rate drops to half that of a continuing smoker Risk of cancer of mouth, throat, esophagus, bladder, kidney, pancreas decrease Time Since Quit Date 2 weeks to 3 months 1 year 10 years 1 to 9 months 5 years after 15 years Lung cilia regain normal function Ability to clear lungs of mucus increases Coughing, fatigue, shortness of breath decrease Risk of stroke is reduced to that of people who have never smoked Risk of CHD is similar to that of people who have never smoked 4

5 FEV 1 (% of value at age 25) BENEFICIAL EFFECTS of QUITTING: PULMONARY EFFECTS AT ANY AGE, there are benefits of quitting Disability Death Smoked regularly and susceptible to effects of smoke Age (years) Never smoked or not susceptible to smoke Stopped smoking at 45 (mild COPD) Stopped smoking at 65 (severe COPD) COPD = chronic obstructive pulmonary disease Reduction in cumulative risk of death from lung cancer in men Cumulative risk (%) Age in years Reprinted with permission. Fletcher & Peto. (1977). BMJ 1(6077): Reprinted with permission. Peto et al. (2000). BMJ 321(7257): Years of life gained Prospective study of 34,439 male British doctors Mortality was monitored for 50 years ( ) SMOKING CESSATION: REDUCED RISK of DEATH Age at cessation (years) On average, cigarette smokers die approximately 10 years younger than do nonsmokers. Among those who continue smoking, at least half will die due to a tobacco-related disease. Doll et al. (2004). BMJ 328(7455): Packs per day FINANCIAL IMPACT of SMOKING Buying cigarettes every day for 50 $4.26 per pack Money banked monthly, earning 1.5% interest $114,243 $228,486 $342, Hundreds of thousands of dollars lost EPIDEMIOLOGY of TOBACCO USE: SUMMARY About one in five adults are current smokers; smoking prevalence varies by sociodemographic characteristics. Nearly half a million U.S. deaths are attributable to smoking annually. Smoking costs the U.S. $157.7 billion per year. Lifetime financial costs of smoking can exceed $300,000 for a heavy smoker. At any age, there are benefits to quitting smoking. The biggest opponent to tobacco control efforts is the tobacco industry itself. NICOTINE PHARMACOLOGY and PRINCIPLES of ADDICTION 5

6 NICOTINE ADDICTION U.S. Surgeon General s Report (1988) Cigarettes and other forms of tobacco are addicting. Nicotine is the drug in tobacco that causes addiction. The pharmacologic and behavioral processes that determine tobacco addiction are similar to those that determine addiction to drugs such as heroin and cocaine. CHEMISTRY of NICOTINE H Pyrrolidine ring N Pyridine ring N CH 3 Nicotiana tabacum Natural liquid alkaloid Colorless, volatile base pk a = 8.0 U.S. Department of Health and Human Services. (1988). The Health Consequences of Smoking: Nicotine Addiction. A Report of the Surgeon General. PHARMACOLOGY Pharmacokinetics Effects of the body on the drug Absorption Distribution Metabolism Excretion Pharmacodynamics Effects of the drug on the body NICOTINE ABSORPTION Absorption is ph dependent In acidic media Ionized poorly absorbed across membranes In alkaline media Nonionized well absorbed across membranes At physiologic ph ( ), ~31% of nicotine is unionized At physiologic ph, nicotine is readily absorbed. NICOTINE ABSORPTION: BUCCAL (ORAL) MUCOSA The ph inside the mouth is 7.0. Acidic media (limited absorption) Cigarettes Alkaline media (significant absorption) Pipes, cigars, spit tobacco, oral nicotine products NICOTINE ABSORPTION: SKIN and GASTROINTESTINAL TRACT Nicotine is readily absorbed through intact skin. Nicotine is well absorbed in the small intestine but has low bioavailability (30%) due to firstpass hepatic metabolism. Beverages can alter ph, affect absorption. 6

7 NICOTINE ABSORPTION: LUNG Nicotine is distilled from burning tobacco and carried in tar droplets. Nicotine is rapidly absorbed across respiratory epithelium. Lung ph = 7.4 Large alveolar surface area Extensive capillary system in lung Plasma nicotine (ng/ml) NICOTINE DISTRIBUTION Nicotine reaches the brain within 11 seconds Venous Arterial Minutes after light-up of cigarette Henningfield et al. (1993). Drug Alcohol Depend 33: NICOTINE METABOLISM N 70 80% cotinine H 10 20% excreted N unchanged in urine CH 3 ~ 10% other metabolites Metabolized and excreted in urine Adapted and reprinted with permission. Benowitz et al. (1994). J Pharmacol Exp Ther 268: NICOTINE EXCRETION Half-life Nicotine t ½ = 2 hr Cotinine t ½ = 19 hr Excretion Occurs through kidneys (ph dependent; with acidic ph) Through breast milk NICOTINE PHARMACODYNAMICS Nicotine binds to receptors in the brain and other sites in the body. Cardiovascular system Gastrointestinal system Other: Neuromuscular junction Sensory receptors Other organs Central nervous system Exocrine glands Adrenal medulla Peripheral nervous system NICOTINE PHARMACODYNAMICS (cont d) Central nervous system Pleasure Arousal, enhanced vigilance Improved task performance Anxiety relief Other Appetite suppression Increased metabolic rate Skeletal muscle relaxation Cardiovascular system Heart rate Cardiac output Blood pressure Coronary vasoconstriction Cutaneous vasoconstriction Nicotine has predominantly stimulant effects. 7

8 NEUROCHEMICAL and RELATED EFFECTS of NICOTINE WHAT IS ADDICTION? N I C O T I N E Dopamine Norepinephrine Acetylcholine Glutamate Serotonin β-endorphin GABA Pleasure, reward Arousal, appetite suppression Arousal, cognitive enhancement Learning, memory enhancement Mood modulation, appetite suppression Reduction of anxiety and tension Reduction of anxiety and tension Compulsive drug use, without medical purpose, in the face of negative consequences Alan I. Leshner, Ph.D. Former Director, National Institute on Drug Abuse National Institutes of Health Benowitz. (1999). Nicotine Tob Res 1(Suppl):S159 S163. BIOLOGY of NICOTINE ADDICTION: ROLE of DOPAMINE Prefrontal cortex DOPAMINE REWARD PATHWAY Nicotine stimulates dopamine release Nicotine addiction is not just a bad habit. Dopamine release Pleasurable feelings Repeat administration Discontinuation leads to withdrawal symptoms. Tolerance develops Nucleus accumbens Ventral tegmental area Stimulation of nicotine receptors Nicotine enters brain CHRONIC ADMINISTRATION of NICOTINE: EFFECTS on the BRAIN High Low Human smokers have increased nicotine receptors in the prefrontal cortex. Nonsmoker Smoker Image courtesy of George Washington University / Dr. David C. Perry Perry et al. (1999). J Pharmacol Exp Ther 289: Depression Insomnia Irritability/frustration/anger Anxiety Difficulty concentrating Restlessness Increased appetite/weight gain Decreased heart rate Cravings* NICOTINE PHARMACODYNAMICS: WITHDRAWAL EFFECTS * Not considered a withdrawal symptom by DSM-IV criteria. Most symptoms peak hr after quitting and subside within 2 4 weeks. HANDOUT American Psychiatric Association. (1994). DSM-IV. Hughes et al. (1991). Arch Gen Psychiatry 48: Hughes & Hatsukami. (1998). Tob Control 7:

9 NICOTINE ADDICTION CYCLE NICOTINE ADDICTION Tobacco users maintain a minimum serum nicotine concentration in order to Prevent withdrawal symptoms Maintain pleasure/arousal Modulate mood Users self-titrate nicotine intake by Smoking/dipping more frequently Smoking more intensely Obstructing vents on low-nicotine brand cigarettes Reprinted with permission. Benowitz. (1992). Med Clin N Am 2: ASSESSING NICOTINE DEPENDENCE Fagerström Test for Nicotine Dependence (FTND) Developed in 1978 (8 items); revised in 1991 (6 items) Most common research measure of nicotine dependence; sometimes used in clinical practice Responses coded such that higher scores indicate higher levels of dependence Scores range from 0 to 10; score of greater than 5 indicates substantial dependence HANDOUT Heatherton et al. (1991). British Journal of Addiction 86: Environment FACTORS CONTRIBUTING to TOBACCO USE Tobacco advertising Conditioned stimuli Social interactions Tobacco Use Pharmacology Alleviation of withdrawal symptoms Weight control Pleasure Physiology Genetic predisposition Coexisting medical conditions TOBACCO DEPENDENCE: A 2-PART PROBLEM Physiological The addiction to nicotine Tobacco Dependence Treatment Medications for cessation Behavioral The habit of using tobacco Treatment Behavior change program Treatment should address the physiological and the behavioral aspects of dependence. NICOTINE PHARMACOLOGY and ADDICTION: SUMMARY Tobacco products are effective delivery systems for the drug nicotine. Nicotine is a highly addictive drug that induces a constellation of pharmacologic effects. Nicotine activates the dopamine reward pathway in the brain, which reinforces continued tobacco use. Tobacco users who are dependent on nicotine selfregulate tobacco intake to maintain pleasurable effects and prevent withdrawal. 9

10 NICOTINE PHARMACOLOGY and ADDICTION: SUMMARY (cont d) Nicotine dependence is a form of chronic brain disease. Tobacco use is a complex disorder involving the interplay of the following: DRUG INTERACTIONS with SMOKING Pharmacology of nicotine (pharmacokinetics and pharmacodynamics) Environmental factors Physiologic factors Treatment of tobacco use and dependence requires a multifaceted treatment approach. PHARMACOKINETIC DRUG INTERACTIONS with SMOKING Drugs that may have a decreased effect due to induction of CYP1A2: Caffeine Fluvoxamine Olanzapine Tacrine Theophylline Absorption of inhaled insulin is 2- to 5-fold higher in smokers than in nonsmokers Use is contraindicated in current smokers and patients who quit less < 6 months prior to treatment Smoking cessation will reverse these effects. HANDOUT PHARMACODYNAMIC DRUG INTERACTIONS with SMOKING Smokers who use combined hormonal contraceptives have an increased risk of serious cardiovascular adverse effects: Stroke Myocardial infarction Thromboembolism This interaction does not decrease the efficacy of hormonal contraceptives. Women who are 35 years of age or older AND smoke at least 15 cigarettes per day are at significantly elevated risk. DRUG INTERACTIONS with SMOKING: SUMMARY Clinicians should be aware of their patients smoking status: Clinically significant interactions result not from nicotine but from the combustion products of tobacco smoke. ASSISTING PATIENTS with QUITTING These tobacco smoke constituents (e.g., polycyclic aromatic hydrocarbons; PAHs) may enhance the metabolism of other drugs, resulting in a reduced pharmacologic response. Smoking might adversely affect the clinical response to the treatment of a wide variety of conditions. 10

11 CLINICAL PRACTICE GUIDELINE for TREATING TOBACCO USE and DEPENDENCE Released June 2000 Sponsored by the Agency for Healthcare Research and Quality of the U.S. Public Heath Service with Centers for Disease Control and Prevention National Cancer Institute National Institute for Drug Addiction National Heart, Lung, & Blood Institute Robert Wood Johnson Foundation Estimated abstinence at 5+ months EFFECTS of CLINICIAN INTERVENTIONS n = 29 studies (0.9,1.3) No clinician Compared to smokers who receive no assistance from a clinician, smokers who receive such assistance are times as likely to quit successfully for 5 or more months. Self-help material 1.7 (1.3,2.1) Nonphysician clinician Type of Clinician 2.2 (1.5,3.2) Physician clinician Fiore et al. (2000). Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: USDHHS, PHS. The CLINICIAN s ROLE in PROMOTING CESSATION Tobacco users expect to be encouraged to quit by health professionals. Screening for tobacco use and providing tobacco cessation counseling are positively associated with patient satisfaction (Barzilai et al., 2001). Failure to address tobacco use tacitly implies that quitting is not important. The 5 A s ASK ADVISE ASSESS ASSIST ARRANGE HANDOUT Barzilai et al. (2001). Prev Med 33: Fiore et al. (2000). Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: USDHHS, PHS. The 5 A s (cont d) Ask ASK about tobacco use Do you ever smoke or use any type of tobacco? I take time to ask all of my patients about tobacco use because it s important. Medication X often is used for conditions linked with or caused by smoking. Do you, or does someone in your household smoke? Condition X often is caused or worsened by smoking. Do you, or does someone in your household smoke? The 5 A s (cont d) ADVISE tobacco users to quit (clear, strong, personalized, sensitive) It s important that you quit as soon as possible, and I can help you. I realize that quitting is difficult. It is the most important thing you can do to protect your health now and in the future. I have training to help my patients quit, and when you are ready, I will work with you to design a specialized treatment plan. 11

12 The 5 A s (cont d) Assess ASSESS readiness to make a quit attempt Assist ASSIST with the quit attempt Not ready to quit: provide motivation (the 5 R s) Ready to quit: design a treatment plan Recently quit: relapse prevention The 5 A s (cont d) Arrange ARRANGE follow-up care Number of sessions 0 to 1 2 to 3 4 to 8 More than 8 Estimated quit rate* 12.4% 16.3% 20.9% 24.7% * 5 months (or more) postcessation PROVIDE ASSISTANCE THROUGHOUT THE QUIT ATTEMPT Fiore et al. (2000). Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: USDHHS, PHS. The 5 A s: REVIEW The (DIFFICULT) DECISION to QUIT ASK ADVISE ASSESS ASSIST ARRANGE about tobacco USE tobacco users to QUIT READINESS to make a quit attempt with the QUIT ATTEMPT FOLLOW-UP care Faced with change, most people are not ready to act. Change is a process, not a single step. Typically, it takes multiple attempts. HOW CAN I LIVE WITHOUT TOBACCO? HELPING SMOKERS QUIT IS a CLINICIAN S RESPONSIBILITY TOBACCO USERS DON T PLAN TO FAIL. MOST FAIL TO PLAN. Clinicians have a professional obligation to address tobacco use and can have an important role in helping patients plan for their quit attempts. THE DECISION TO QUIT LIES IN THE HANDS OF EACH PATIENT. ASSESSING READINESS to QUIT Patients differ in their readiness to quit. STAGE 1: Not ready to quit in the next month STAGE 2: Ready to quit in the next month STAGE 3: Recent quitter, quit within past 6 months STAGE 4: Former tobacco user, quit > 6 months ago Assessing a patient s readiness to quit enables clinicians to deliver relevant, appropriate counseling messages. 12

13 ASSESSING READINESS to QUIT (cont d) For most patients, quitting is a cyclical process, and their readiness to quit (or stay quit) will change over time. IS a PATIENT READY to QUIT? Does the patient now use tobacco? Yes No Relapse Former tobacco user Not thinking about it Not ready to quit Is the patient now ready to quit? No Yes Did the patient once use tobacco? Yes No Recent quitter Ready to quit Thinking about it, not ready Assess readiness to quit (or to stay quit) at each patient contact. Promote motivation Provide treatment The 5 A s Prevent relapse* Encourage continued abstinence *Relapse prevention interventions not necessary if patient has not used tobacco for many years and is not at risk for re-initiation. Fiore et al. (2000). Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: USDHHS, PHS. ASSESSING READINESS to QUIT (cont d) STAGE 1: Not ready to quit Not thinking about quitting in the next month Some patients are aware of the need to quit. Patients struggle with ambivalence about change. Patients are not ready to change, yet. Pros of continued tobacco use outweigh the cons. GOAL: Start thinking about quitting. DOs STAGE 1: NOT READY to QUIT Counseling Strategies Strongly advise to quit Provide information Ask noninvasive questions; identify reasons for tobacco use Envelope Raise awareness of health consequences/concerns Demonstrate empathy, foster communication Leave decision up to patient DON Ts Persuade Cheerlead Tell patient how bad tobacco is, in a judgmental manner Provide a treatment plan STAGE 1: NOT READY to QUIT Counseling Strategies (cont d) STAGE 1: NOT READY to QUIT A Demonstration The 5 R s Methods for increasing motivation: Relevance Risks Rewards Roadblocks Repetition Tailored, motivational messages CASE SCENARIO: MS. STEWART You are a clinician providing care to Ms. Stewart, a 55-year-old patient with emphysema. She uses two different inhalers to treat her emphysema. Fiore et al. (2000). Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: USDHHS, PHS. VIDEO #1 13

14 STAGE 1: NOT READY to QUIT Case Scenario Synopsis Ask about tobacco use Link inquiry to knowledge of disease Assess readiness to quit Aware of need to quit; not ready yet Advise to quit Discuss implications for disease progression STAGE 1: NOT READY to QUIT Case Scenario Synopsis (cont d) The clinician has Established a relationship Established herself as a resource Planted a seed to move patient forward Opened a door to facilitate further counseling I will help you, when you are ready ASSESSING READINESS to QUIT (cont d) STAGE 2: Ready to quit Ready to quit in the next month Patients are aware of the need to, and the benefits of, making the behavioral change. STAGE 2: READY to QUIT Three Key Elements of Counseling Assess tobacco use history Discuss key issues Facilitate quitting process Patients are getting ready to take action. GOAL: Achieve cessation. STAGE 2: READY to QUIT Assess Tobacco Use History Praise the patient s readiness Assess tobacco use history Current use: type(s) of tobacco, brand, amount Past use: duration, recent changes Past quit attempts: Number, date, length Methods used, compliance, duration Reasons for relapse STAGE 2: READY to QUIT Discuss Key Issues Reasons/motivation to quit (or avoid relapse) Confidence in ability to quit (or avoid relapse) Triggers for tobacco use What situations lead to temptations to use tobacco? What led to relapse in the past? Routines/situations associated with tobacco use When drinking coffee While driving in the car When bored or stressed While watching television While at a bar with friends After meals During breaks at work While on the telephone While with specific friends or family members who use tobacco 14

15 STAGE 2: READY to QUIT Discuss Key Issues (cont d) Stress-Related Tobacco Use THE MYTHS Smoking gets rid of all my stress. I can t relax without a cigarette. THE FACTS There will always be stress in one s life. There are many ways to relax without a cigarette. Smokers confuse the relief of withdrawal with the feeling of relaxation. STRESS MANAGEMENT SUGGESTIONS: Deep breathing, shifting focus, taking a break. STAGE 2: READY to QUIT Discuss Key Issues (cont d) Social Support for Quitting ADVISE PATIENTS TO DO THE FOLLOWING: Ask family, friends, and coworkers for support, for example, not to smoke around them and not to leave cigarettes out Talk with their health care provider Get individual, group, or telephone counseling Patients who receive social support and encouragement are more successful in quitting. HERMAN is reprinted with permission from LaughingStock Licensing Inc., Ottawa, Canada All rights reserved. Most smokers gain fewer than 10 pounds, but there is a wide range. STAGE 2: READY to QUIT Discuss Key Issues (cont d) Concerns about Weight Gain Discourage strict dieting while quitting Recommend physical activity Encourage healthful diet, planning of meals, and inclusion of fruits Suggest increasing water intake or chewing sugarless gum Recommend selection of nonfood rewards Maintain patient on pharmacotherapy shown to delay weight gain Refer patient to specialist or program STAGE 2: READY to QUIT Discuss Key Issues (cont d) Concerns about Withdrawal Symptoms Most pass within 2 4 weeks after quitting Cravings can last longer, up to several months or years Often can be ameliorated with cognitive or behavioral coping strategies Refer to Withdrawal Symptoms Information Sheet Symptom, cause, duration, relief Most symptoms peak hours after quitting and subside within 2 4 weeks. HANDOUT Discuss methods for quitting Discuss pros and cons of available methods Pharmacotherapy: a treatment, not a crutch! Importance of behavioral counseling Set a quit date STAGE 2: READY to QUIT Facilitate Quitting Process Recommend Tobacco Use Log HANDOUT Helps patients to understand when and why they use tobacco Identifies activities or situations that trigger tobacco use Can be used to develop coping strategies to overcome the temptation to use tobacco 15

16 STAGE 2: READY to QUIT Facilitate Quitting Process (cont d) Tobacco Use Log: Instructions for use Continue regular tobacco use for 3 or more days Each time any form of tobacco is used, log the following information: Time of day Activity or situation during use Importance rating (scale of 1 3) STAGE 2: READY to QUIT Facilitate Quitting Process (cont d) Discuss coping strategies Cognitive coping strategies Focus on retraining the way a patient thinks Behavioral coping strategies HANDOUT Involve specific actions to reduce risk for relapse Review log to identify situational triggers for tobacco use; develop patient-specific coping strategies STAGE 2: READY to QUIT Facilitate Quitting Process (cont d) Cognitive Coping Strategies Review commitment to quit Distractive thinking Positive self-talk Relaxation through imagery Mental rehearsal and visualization STAGE 2: READY to QUIT Facilitate Quitting Process (cont d) Cognitive Coping Strategies: Examples Thinking about cigarettes doesn t mean you have to smoke one: Just because you think about something doesn t mean you have to do it! Tell yourself, It s just a thought, or I am in control. Say the word STOP! out loud, or visualize a stop sign. When you have a craving, remind yourself: The urge for tobacco will only go away if I don t use it. As soon as you get up in the morning, look in the mirror and say to yourself: I am proud that I made it through another day without tobacco. STAGE 2: READY to QUIT Facilitate Quitting Process (cont d) Behavioral Coping Strategies Control your environment Tobacco-free home and workplace Remove cues to tobacco use; actively avoid trigger situations Modify behaviors that you associate with tobacco: when, what, where, how, with whom Substitutes for smoking Water, sugar-free chewing gum or hard candies (oral substitutes) Take a walk, diaphragmatic breathing, self-massage Actively work to reduce stress, obtain social support, and alleviate withdrawal symptoms STAGE 2: READY to QUIT Facilitate Quitting Process (cont d) Provide medication counseling Promote compliance Discuss proper use, with demonstration Discuss concept of slip versus relapse Let a slip slide. Offer to assist throughout quit attempt Follow-up contact #1: first week after quitting Follow-up contact #2: in the first month Additional follow-up contacts as needed Congratulate the patient! 16

17 ASSESSING READINESS to QUIT (cont d) STAGE 3: Recent quitter Actively trying to quit for good Patients have quit using tobacco sometime in the past 6 months and are taking steps to increase their success. Withdrawal symptoms occur. Patients are at risk for relapse. GOAL: Remain tobacco-free for at least 6 months. STAGE 3: RECENT QUITTERS Evaluate the Quit Attempt Status of attempt Ask about social support Identify ongoing temptations and triggers for relapse (negative affect, smokers, eating, alcohol, cravings, stress) Encourage healthy behaviors to replace tobacco use Slips and relapse Has the patient used tobacco at all even a puff? Medication compliance, plans for termination Is the regimen being followed? Are withdrawal symptoms being alleviated? How and when should pharmacotherapy be terminated? Congratulate success! Encourage continued abstinence Discuss benefits of quitting, problems encountered, successes achieved, and potential barriers to continued abstinence Ask about strong or prolonged withdrawal symptoms (change dose, combine or extend use of medications) Promote smoke-free environments Social support STAGE 3: RECENT QUITTERS Facilitate Quitting Process Relapse Prevention Discuss ongoing sources of support Schedule additional follow-up as needed; refer to support groups ASSESSING READINESS to QUIT (cont d) STAGE 4: Former tobacco user Tobacco-free for 6 months Patients remain vulnerable to relapse. Ongoing relapse prevention is needed. GOAL: Remain tobacco-free for life. STAGE 4: FORMER TOBACCO USERS READINESS to QUIT: A REVIEW Assess status of quit attempt Slips and relapse Medication compliance, plans for termination Has pharmacotherapy been terminated? Not ready to quit Quit date - 30 days + 6 months Recent quitter Former tobacco user Continue to offer tips for relapse prevention Encourage healthy behaviors Congratulate continued success Continue to assist throughout the quit attempt. Promote motivation The 5 R s Behavioral counseling Pharmacotherapy Relapse prevention Ready to quit Behavioral counseling Pharmacotherapy The 5 A s Behavioral counseling Relapse prevention 17

18 COMPREHENSIVE COUNSELING: SUMMARY Routinely identify tobacco users (ASK) Strongly ADVISE patients to quit ASSESS readiness to quit at each contact Tailor intervention messages (ASSIST) Be a good listener Minimal intervention in absence of time for more intensive intervention ARRANGE follow-up Use the referral process, if needed BRIEF COUNSELING: ASK, ADVISE, REFER Brief interventions have been shown to be effective In the absence of time or expertise: Ask, advise, and refer to other resources, such as local programs or the toll-free quitline QUIT-NOW This brief intervention can be achieved in 30 seconds. WHAT IF a patient asks you about your use of tobacco? The RESPONSIBILITY of HEALTH PROFESSIONALS It is inconsistent to provide health care and at the same time remain silent (or inactive) about a major health risk. TOBACCO CESSATION is an important component of THERAPY. DR. GRO HARLEM BRUNTLAND, FORMER DIRECTOR-GENERAL of the WHO: If we do not act decisively, a hundred years from now our grandchildren and their children will look back and seriously question how people claiming to be committed to public health and social justice allowed the tobacco epidemic to unfold unchecked. AIDS for CESSATION & CASE SCENARIO OVERVIEW USDHHS. (2001). Women and Smoking: A Report of the Surgeon General. Washington, DC: PHS. 18

19 METHODS for QUITTING Nonpharmacologic Pharmacologic Combination therapy is preferred. NONPHARMACOLOGIC METHODS Cold turkey: Just do it! Unassisted tapering (fading) Reduced frequency of use Lower nicotine cigarettes Special filters or holders Assisted tapering QuitKey NONPHARMACOLOGIC METHODS (cont d) SCHEDULED GRADUAL REDUCTION of SMOKING Formal cessation programs Self-help programs Individual counseling Group programs Telephone counseling QUITNOW Web-based counseling Aversion therapy Acupuncture therapy Hypnotherapy Massage therapy Gradual reduction of the total number of cigarettes smoked per day Computerized unit facilitates reduction: QuitKey Tapering curve developed based on patient s smoking level 19 24% abstinent at 1 year Includes telephone counseling support QuitKey SMOKING CESSATION PROGRAM QuitKey SMOKING CESSATION PROGRAM Stage 1 (7 days) Push the SMOKE button every time you smoke, to record smoking habits Turn unit on every morning and off every night Stage 2 (14 34 days) Smoke only when you hear the tone or see the SMOKE SIGNAL; tapers smoking over time Press the SMOKE button every time you smoke Turn unit on every morning and off every night 19

20 SCHEDULED GRADUAL REDUCTION (cont d) Who is a candidate for scheduled gradual reduction? Anyone who wants to quit smoking Particularly useful in persons for whom medications might not be a first-line choice, such as pregnant women or teens Spit tobacco users (18.4% abstinent after 1 year) Ordering information or ($59.95) PHARMACOTHERAPY All patients attempting to quit should be encouraged to use effective pharmacotherapies for smoking cessation except in the presence of special circumstances. Fiore et al. (2000). Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: USDHHS, PHS. PHARMACOLOGIC METHODS: FIRST-LINE THERAPIES Three general classes of FDA-approved drugs for smoking cessation: Nicotine replacement therapy (NRT) Nicotine gum, patch, lozenge, nasal spray, inhaler Psychotropics Sustained-release bupropion Partial nicotinic receptor agonist Varenicline Currently, no medications have an FDA indication for use in spit tobacco cessation. Rx nicotine gum 1984 FDA APPROVALS: SMOKING CESSATION Rx transdermal nicotine patch 1991 Rx nicotine inhaler; Rx bupropion SR OTC nicotine gum & patch; Rx nicotine nasal spray OTC nicotine lozenge 2006 Rx varenicline NRT: RATIONALE for USE Reduces physical withdrawal from nicotine Allows patient to focus on behavioral and psychological aspects of tobacco cessation NRT APPROXIMATELY DOUBLES QUIT RATES. NRT: PRODUCTS Polacrilex gum Nasal spray Nicorette (OTC) Nicotrol NS (Rx) Generic nicotine gum (OTC) Lozenge Inhaler Commit (OTC) Nicotrol (Rx) Generic nicotine lozenge (OTC) Transdermal patch Nicoderm CQ (OTC) Generic nicotine patches (OTC, Rx) 20

21 PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS NRT: PRECAUTIONS Plasma nicotine (mcg/l) Cigarette Moist snuff Cigarette Moist snuff Nasal spray Inhaler Lozenge (2mg) Gum (2mg) Patients with underlying cardiovascular disease Recent myocardial infarction (within past 2 weeks) Serious arrhythmias Serious or worsening angina Patch 0 1/0/ /10/ /20/1900 1/30/1900 2/9/ /19/ /29/ Time (minutes) NRT products may be appropriate for these patients if they are under medical supervision. NRT: PRECAUTIONS (cont d) Patients with other underlying conditions Active temporomandibular joint disease (gum only) Pregnancy Lactation NRT products may be appropriate for these patients if they are under medical supervision. NRT: OTHER CONSIDERATIONS NRT is not FDA-approved for use in children or adolescents Nonprescription sales (patch, gum, lozenge) are restricted to adults 18 years of age NRT use in minors requires a prescription Patients should stop using all forms of tobacco upon initiation of the NRT regimen NICOTINE GUM Nicorette (GlaxoSmithKline); generics Resin complex Nicotine Polacrilin Sugar-free chewing gum base Contains buffering agents to enhance buccal absorption of nicotine Available: 2 mg, 4 mg; regular, FreshMint, Fruit Chill, mint, & orange flavor NICOTINE GUM: DOSING Dosage based on current smoking patterns: If patient smokes Recommended strength 25 cigarettes/day 4 mg <25 cigarettes/day 2 mg 21

22 NICOTINE GUM: DOSING (cont d) NICOTINE GUM: DIRECTIONS for USE Chew each piece very slowly several times Recommended Usage Schedule for Nicotine Gum Weeks 1 6 Weeks 7 9 Weeks piece q 1 2 h 1 piece q 2 4 h 1 piece q 4 8 h DO NOT USE MORE THAN 24 PIECES PER DAY. Stop chewing at first sign of peppery, minty, or citrus taste or slight tingling in mouth (~15 chews, but varies) Park gum between cheek and gum (to allow absorption of nicotine across buccal mucosa) Resume slow chewing when taste or tingle fades When taste or tingle returns, stop and park gum in different place in mouth Repeat chew/park steps until most of the nicotine is gone (taste or tingle does not return; generally 30 minutes) NICOTINE GUM: CHEWING TECHNIQUE SUMMARY Chew slowly NICOTINE GUM: ADDITIONAL PATIENT EDUCATION To improve chances of quitting, use at least nine pieces of gum daily Chew again when peppery taste or tingle fades Stop chewing at first sign of peppery taste or tingling sensation The effectiveness of nicotine gum may be reduced by some foods and beverages: Coffee Juices Wine Soft drinks Park between cheek & gum Do NOT eat or drink for 15 minutes BEFORE or while using nicotine gum. NICOTINE GUM: ADD L PATIENT EDUCATION (cont d) Chewing gum will not provide same rapid satisfaction that smoking provides Chewing gum too rapidly can cause excessive release of nicotine, resulting in Lightheadedness Nausea/vomiting Irritation of throat and mouth Hiccups Indigestion NICOTINE GUM: ADD L PATIENT EDUCATION (cont d) Side effects of nicotine gum include Mouth soreness Hiccups Dyspepsia Jaw muscle ache Nicotine gum may stick to dental work Discontinue use if excessive sticking or damage to dental work occurs 22

23 NICOTINE GUM: SUMMARY ADVANTAGES Gum use may satisfy oral cravings. Gum use may delay weight gain. Patients can titrate therapy to manage withdrawal symptoms. DISADVANTAGES Gum chewing may not be socially acceptable. Gum is difficult to use with dentures. Patients must use proper chewing technique to minimize adverse effects. NICOTINE LOZENGE Commit (GlaxoSmithKline); generics Nicotine polacrilex formulation Delivers ~25% more nicotine than equivalent gum dose Sugar-free, mint or cherry flavor (boxed or POP-PAC) Contains buffering agents to enhance buccal absorption of nicotine Available: 2 mg, 4 mg NICOTINE LOZENGE: DOSING Dosage is based on the time to first cigarette (TTFC) as an indicator of nicotine addiction Use Commit Lozenge 2 mg: If you smoke your first cigarette more than 30 minutes after waking up Use Commit Lozenge 4 mg: If you smoke your first cigarette of the day within 30 minutes of waking up NICOTINE LOZENGE: DOSING (cont d) Recommended Usage Schedule for Commit Lozenge Weeks 1 6 Weeks 7 9 Weeks lozenge q 1 2 h 1 lozenge q 2 4 h 1 lozenge q 4 8 h DO NOT USE MORE THAN 20 LOZENGES PER DAY. NICOTINE LOZENGE: DIRECTIONS for USE Use according to recommended dosing schedule Place in mouth and allow to dissolve slowly (nicotine release may cause warm, tingling sensation) Do not chew or swallow lozenge. Occasionally rotate to different areas of the mouth. Lozenge will dissolve completely in about minutes. NICOTINE LOZENGE: ADDITIONAL PATIENT EDUCATION To improve chances of quitting, use at least nine lozenges daily during the first 6 weeks The lozenge will not provide the same rapid satisfaction that smoking provides The effectiveness of the nicotine lozenge may be reduced by some foods and beverages: Coffee Juices Wine Soft drinks Do NOT eat or drink for 15 minutes BEFORE or while using the nicotine lozenge. 23

24 NICOTINE LOZENGE: ADD L PATIENT EDUCATION (cont d) NICOTINE LOZENGE: SUMMARY Side effects of the nicotine lozenge include Nausea Hiccups Cough Heartburn Headache Flatulence Insomnia ADVANTAGES Lozenge use may satisfy oral cravings. The lozenge is easy to use and conceal. Patients can titrate therapy to manage withdrawal symptoms. DISADVANTAGES Gastrointestinal side effects (nausea, hiccups, and heartburn) may be bothersome. TRANSDERMAL NICOTINE PATCH Nicoderm CQ (GlaxoSmithKline); generic TRANSDERMAL NICOTINE PATCH: PREPARATION COMPARISON Nicotine is well absorbed across the skin Delivery to systemic circulation avoids hepatic firstpass metabolism Plasma nicotine levels are lower and fluctuate less than with smoking Product Nicotine delivery Availability Nicoderm CQ 24 hours OTC Generic 24 hours Rx/OTC Strengths 7-mg patch 14-mg patch 21-mg patch 7-mg patch 14-mg patch 21-mg patch TRANSDERMAL NICOTINE PATCH: DOSING TRANSDERMAL NICOTINE PATCH: DIRECTIONS for USE Product Nicoderm CQ Generic (formerly Habitrol) Light Smoker 10 cigarettes/day Step 2 (14 mg x 6 weeks) Step 3 (7 mg x 2 weeks) 10 cigarettes/day Step 2 (14 mg x 6 weeks) Step 3 (7 mg x 2 weeks) Heavy Smoker >10 cigarettes/day Step 1 (21 mg x 6 weeks) Step 2 (14 mg x 2 weeks) Step 3 (7 mg x 2 weeks) >10 cigarettes/day Step 1 (21 mg x 4 weeks) Step 2 (14 mg x 2 weeks) Step 3 (7 mg x 2 weeks) Choose an area of skin on the upper body or upper outer part of the arm Make sure skin is clean, dry, hairless, and not irritated Apply patch to different area each day Do not use same area again for at least 1 week 24

25 TRANSDERMAL NICOTINE PATCH: DIRECTIONS for USE (cont d) Remove patch from protective pouch TRANSDERMAL NICOTINE PATCH: DIRECTIONS for USE (cont d) Peel off half of the backing from patch TRANSDERMAL NICOTINE PATCH: DIRECTIONS for USE (cont d) Apply adhesive side of patch to skin Peel off remaining protective covering Press firmly with palm of hand for 10 seconds Make sure patch sticks well to skin, especially around edges TRANSDERMAL NICOTINE PATCH: DIRECTIONS for USE (cont d) Wash hands: Nicotine on hands can get into eyes or nose and cause stinging or redness Do not leave patch on skin for more than 24 hours doing so may lead to skin irritation Adhesive remaining on skin may be removed with rubbing alcohol or acetone Dispose of used patch by folding it onto itself, completely covering adhesive area TRANSDERMAL NICOTINE PATCH: ADDITIONAL PATIENT EDUCATION Water will not harm the nicotine patch if it is applied correctly; patients may bathe, swim, shower, or exercise while wearing the patch Do not cut patches to adjust dose Nicotine may evaporate from cut edges Patch may be less effective Keep new and used patches out of the reach of children and pets Remove patch before MRI procedures TRANSDERMAL NICOTINE PATCH: ADD L PATIENT EDUCATION (cont d) Side effects to expect in first hour: Mild itching Burning Tingling Additional possible side effects: Vivid dreams or sleep disturbances Headache 25

26 TRANSDERMAL NICOTINE PATCH: ADD L PATIENT EDUCATION (cont d) After patch removal, skin may appear red for 24 hours If skin stays red more than 4 days or if it swells or a rash appears, contact health care provider do not apply new patch Local skin reactions (redness, burning, itching) Usually caused by adhesive Up to 50% of patients experience this reaction Fewer than 5% of patients discontinue therapy Avoid use in patients with dermatologic conditions (e.g., psoriasis, eczema, atopic dermatitis) TRANSDERMAL NICOTINE PATCH: SUMMARY ADVANTAGES DISADVANTAGES The patch provides consistent nicotine levels. The patch is easy to use and conceal. Fewer compliance issues are associated with patch use. Patients cannot titrate the dose. Allergic reactions to the adhesive may occur. Patients with dermatologic conditions should not use the patch. NICOTINE NASAL SPRAY Nicotrol NS (Pfizer) Aqueous solution of nicotine in a 10-ml spray bottle Each metered dose actuation delivers 50 µl spray 0.5 mg nicotine ~100 doses/bottle Rapid absorption across nasal mucosa NICOTINE NASAL SPRAY: DOSING & ADMINISTRATION One dose = 1 mg nicotine (2 sprays, one 0.5 mg spray in each nostril) Start with 1 2 doses per hour Increase prn to maximum dosage of 5 doses per hour or 40 mg (80 sprays; ~½ bottle) daily For best results, patients should use at least 8 doses daily for the first 6 8 weeks Termination: Gradual tapering over an additional 4 6 weeks NICOTINE NASAL SPRAY: DIRECTIONS for USE Press in circles on sides of bottle and pull to remove cap NICOTINE NASAL SPRAY: DIRECTIONS for USE (cont d) Prime the pump (before first use) Obtain facial tissue or paper towel Hold bottle and press on bottom with thumb Pump into tissue until fine spray is observed (6 8 times) If pump is not used for 24 hours, prime the pump 1 2 times 26

27 NICOTINE NASAL SPRAY: DIRECTIONS for USE (cont d) Blow nose (if not clear) Tilt head back slightly and insert tip of bottle into nostril as far as comfortable Breathe through mouth, and spray once in each nostril Do not sniff or inhale while spraying NICOTINE NASAL SPRAY: DIRECTIONS for USE (cont d) If nose runs, gently sniff to keep nasal spray in nose Wait 2 3 minutes before blowing nose Wait 5 minutes before driving or operating heavy machinery (spray may cause tearing, coughing, and sneezing) Avoid contact with skin, eyes, and mouth If contact occurs, rinse with water immediately Nicotine is absorbed through skin and mucous membranes NICOTINE NASAL SPRAY: ADDITIONAL PATIENT EDUCATION NICOTINE NASAL SPRAY: SUMMARY What to expect (first week): Hot peppery feeling in back of throat or nose Sneezing Coughing Watery eyes Runny nose Side effects should lessen over a few days Regular use during the first week will help in development of tolerance to the irritant effects of the spray If side effects do not decrease after a week, contact health care provider ADVANTAGES Patients can easily titrate therapy to rapidly manage withdrawal symptoms. DISADVANTAGES Nasal/throat irritation may be bothersome. Nasal spray has higher dependence potential. Patients with chronic nasal disorders or severe reactive airway disease should not use the spray. NICOTINE INHALER Nicotrol Inhaler (Pfizer) Nicotine inhalation system consists of Mouthpiece Cartridge with porous plug containing 10 mg nicotine Delivers 4 mg nicotine vapor, absorbed across buccal mucosa May satisfy hand-to-mouth ritual of smoking NICOTINE INHALER: DOSING Start with 6 cartridges/day Increase prn to maximum of 16 cartridges/day Use for minimum of 3 weeks, maximum of 12 weeks Gradual dosage reduction: if needed over additional 6 12 weeks 27

28 NICOTINE INHALER: SCHEMATIC DIAGRAM Aluminum laminate sealing material Sharp point that breaks the seal Air/nicotine mixture out NICOTINE INHALER: DIRECTIONS for USE Align marks on the mouthpiece Sharp point that breaks the seal Mouthpiece Air in Nicotine cartridge Porous plug impregnated with nicotine Reprinted with permission from Schneider et al. (2001). Clinical Pharmacokinetics 40: Adis International, Inc. NICOTINE INHALER: DIRECTIONS for USE (cont d) Pull and separate mouthpiece into two parts NICOTINE INHALER: DIRECTIONS for USE (cont d) Press nicotine cartridge firmly into bottom of mouthpiece until seal breaks NICOTINE INHALER: DIRECTIONS for USE (cont d) Put top on mouthpiece and align marks to close Press down firmly to break top seal of cartridge Twist top to misalign marks and secure unit NICOTINE INHALER: DIRECTIONS for USE (cont d) During inhalation, nicotine is vaporized and absorbed across oropharyngeal mucosa Inhale into back of throat or puff in short breaths Nicotine in cartridges is depleted after about 20 minutes of active puffing Cartridge does not have to be used all at once Open cartridge retains potency for 24 hours Mouthpiece is reusable; clean regularly with mild detergent 28

29 NICOTINE INHALER: ADDITIONAL PATIENT EDUCATION Patients may experience mild irritation of the mouth or throat, and an unpleasant taste or cough when first using the inhaler Patients will adapt to these effects in a short time Other (less common) side effects include Rhinitis Dyspepsia Hiccups Headache NICOTINE INHALER: ADD L PATIENT EDUCATION (cont d) The inhaler may not be as effective in very cold (<59 F) temperatures delivery of nicotine vapor may be compromised Use the inhaler longer and more often at first to help control cravings (best results are achieved with frequent continuous puffing over 20 minutes) Effectiveness of the nicotine inhaler may be reduced by some foods and beverages Do NOT eat or drink for 15 minutes BEFORE or while using the nicotine inhaler. ADVANTAGES NICOTINE INHALER: SUMMARY Patients can easily titrate therapy to manage withdrawal symptoms. The inhaler mimics the hand-to-mouth ritual of smoking. DISADVANTAGES The initial throat or mouth irritation can be bothersome. Cartridges should not be stored in very warm conditions or used in very cold conditions. Patients with underlying bronchospastic disease must use the inhaler with caution. BUPROPION SR Zyban (GlaxoSmithKline); generic Nonnicotine cessation aid Sustained-release antidepressant Oral formulation BUPROPION: MECHANISM of ACTION Atypical antidepressant thought to affect levels of various brain neurotransmitters Dopamine Norepinephrine Clinical effects craving for cigarettes symptoms of nicotine withdrawal BUPROPION: PHARMACOKINETICS Absorption Bioavailability: 5 20% Metabolism Undergoes extensive hepatic metabolism (CYP2B6) Elimination Urine (87%) and feces (10%) Half-life Bupropion (21 hours); metabolites (20 37 hours) 29

30 BUPROPION: CONTRAINDICATIONS Patients with a seizure disorder Patients taking Wellbutrin, Wellbutrin SR, Wellbutrin XL MAO inhibitors in preceding 14 days Patients with a current or prior diagnosis of anorexia or bulimia nervosa Patients undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines) BUPROPION: WARNINGS and PRECAUTIONS Bupropion should be used with extreme caution in the following populations: Patients with a history of seizure Patients with a history of cranial trauma Patients taking medications that lower the seizure threshold (antipsychotics, antidepressants, theophylline, systemic steroids) Patients with severe hepatic cirrhosis BUPROPION: USE in PREGNANCY Category C drug Use only if clearly indicated Attempt nondrug treatment first BUPROPION SR: DOSING Patients should begin therapy 1 to 2 weeks PRIOR to their quit date to ensure that therapeutic plasma levels of the drug are achieved. Initial treatment 150 mg po q AM x 3 days Then 150 mg po bid Duration, 7 12 weeks BUPROPION: ADVERSE EFFECTS Common side effects include the following: Insomnia (avoid bedtime dosing) Dry mouth Less common but reported effects: Tremor Skin rash BUPROPION: ADDITIONAL PATIENT EDUCATION Dose tapering not necessary when discontinuing treatment If no significant progress toward abstinence by seventh week, therapy is unlikely to be effective Discontinue treatment Reevaluate and restart at later date 30

31 ADVANTAGES BUPROPION SR: SUMMARY Bupropion is an oral formulation with twice-a-day dosing. Bupropion might be beneficial for patients with depression. DISADVANTAGES The seizure risk is increased. Several contraindications and precautions preclude use. VARENICLINE Chantix (Pfizer) Nonnicotine cessation aid Partial nicotinic receptor agonist Oral formulation VARENICLINE: MECHANISM of ACTION Binds with high affinity and selectivity at α 4 β 2 neuronal nicotinic acetylcholine receptors Stimulates low-level agonist activity Competitively inhibits binding of nicotine Clinical effects symptoms of nicotine withdrawal Blocks dopaminergic stimulation responsible for reinforcement & reward associated with smoking Absorption VARENICLINE: PHARMACOKINETICS Virtually complete after oral administration; not affected by food Metabolism Undergoes minimal metabolism Elimination Primarily renal through glomerular filtration and active tubular secretion; 92% excreted unchanged in urine Half-life 24 hours VARENICLINE : USE in PREGNANCY and LACTATION Category C drug Use only if potential benefit justifies potential risk Attempt nondrug treatment first Unknown if drug excreted in human breast milk VARENICLINE: DOSING Patients should begin therapy 1 week PRIOR to their quit date. The dose is gradually increased to minimize treatment-related nausea and insomnia. Initial dose titration Treatment Day Day 1 to day 3 Day 4 to day 7 Day 8 to end of treatment* Dose 0.5 mg qd 0.5 mg bid 1 mg bid * Up to 12 weeks 31