“CIGARETTE SMOKING… 2... · World Health Organization Report on the Global Tobacco Epidemic...

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Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.

Rx for CHANGEClinician-Assisted Tobacco Cessation

TRAINING OVERVIEW

Epidemiology of Tobacco Use

Forms of Tobacco Nicotine Pharmacology & Principles of Addiction

Drug Interactions with Smoking Assisting Patients with Quitting

Aids for Cessation

Tobacco Trigger Tapes

Role Playing with Case Scenarios and Video Counseling Sessions

EPIDEMIOLOGY of TOBACCO USE 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

“CIGARETTE SMOKING…

All forms of tobacco are harmful.

World Health Organization Report on the Global Tobacco Epidemic (2008).

WORLDWIDE ADULT TOBACCO USE PREVALENCE (Men/Women)

USA21.5/17.3

UK/Northern Ireland

27.0/25.0

China66.0/3.1

Russian Federation60.4/15.5

Japan43.3/12.0

India32.7/1.4Brazil

20.3/12.8

South Africa36.0/10.2

Iran24.1/4.3

Philippines57.5/12.3

France33.3/26.5

TRENDS in ADULT CIGARETTE CONSUMPTION—U.S., 1900–2006

Annual adult per capita cigarette consumption and major smoking and health events

Centers for Disease Control and Prevention (CDC). (1999). MMWR 48:986–993.Per-capita updates from U.S. Department of Agriculture, provided by the American Cancer Society.

0

1,000

2,000

3,000

4,000

5,000

1900 1910 1920 1930 1940 1950 1960 1970 1980 1990 2000

1964 SurgeonGeneral’s Report

Great Depression

End of WW II

First modern reports linking smoking and cancer Federal cigarette

tax doubles

MasterSettlementAgreement; California first state to enact ban on smoking in bars

Broadcastad ban

Cigarette price drop

Nonsmokers’ rights movement

beginsNu

mb

er o

f ci

gar

ette

s

Year

U.S. entry into WW I

20 states have > $1

pack tax

Marketing of filtered cigarettes

2


Chaloupka FJ. (2010). The economics of tobacco taxation. Chicago, IL: ImpacTEEN, University of Illinois at Chicago.

$1.50

$2.00

$2.50

$3.00

$3.50

$4.00

$4.50

15950

17950

19950

21950

23950

25950

27950

29950

1970 1975 1980 1985 1990 1995 2000 2005 Pri

ce p

er p

ack

(O

ct 2

009

do

llar

s)

Sal

es (

mill

ion

pac

ks)

Year

Sales Price

CIGARETTE PRICES and CIGARETTE SALES, 1970–2009

TRENDS in ADULT SMOKING, by SEX—U.S., 1955–2010

Trends in cigarette current smoking among persons aged 18 or older

Graph provided by the Centers for Disease Control and Prevention. 1955 Current Population Survey; 1965–2010 NHIS. Estimates since 1992 include some-day smoking.

Per

cen

t

68.8% want to quit52.4% tried to quit in the past year

0

10

20

30

40

50

60

1955 1960 1965 1970 1975 1980 1985 1990 1995 2000 2005 2010

Male

Female 21.5%17.3%

19.3% of adults are current

smokers

Year

STATE-SPECIFIC PREVALENCE of SMOKING among ADULTS, 2010

* Has smoked ≥ 100 cigarettes during lifetime and currently smokes either every day or some days.Centers for Disease Control and Prevention (CDC). (2011). MMWR 60:1207–1212.

< 13.0%13.0 – 15.9%16.0 – 18.9%19.0 – 21.9%≥ 22.0%

Prevalence of current* smoking (2010)

PREVALENCE of ADULT SMOKING, by RACE/ETHNICITY—U.S., 2010

Centers for Disease Control and Prevention (CDC). (2011). MMWR 60:1207–1212.

0 10 20 30 40

9.2%

25.9%

20.6%

21.0%

12.5%

31.4%

Percent

Asian

American Indian/Alaska Native

Black

White

Hispanic

Multiple races

PREVALENCE of ADULT SMOKING, by EDUCATION—U.S., 2010

0 10 20 30 40 50

Percent

Undergraduate degree

No high school diploma

GED diploma

High school graduate

Some college

9.9%

Graduate degree

25.1%

23.8%

23.2%

6.3%

45.2%


TRENDS in TEEN SMOKING, by ETHNICITY—U.S., 1977–2010

Trends in cigarette smoking among 12th graders: 30-day prevalence of use

0

10

20

30

40

50

1977 1982 1987 1992 1997 2002 2007Year

Institute for Social Research, University of Michigan, Monitoring the Future Projectwww.monitoringthefuture.org

Pe

rce

nt

White

Hispanic

Black

3


PUBLIC HEALTH versus “BIG TOBACCO”

The biggest opponent to tobacco control efforts is the tobacco

industry itself.

Nationally, the tobacco industry is outspending our state tobacco control funding.

For every $1 spent by the states, the tobacco industry spends $23 to market its products.

TOBACCO INDUSTRY MARKETING

$12.49 billion spent in the U.S. in 2006 $34.2 million a day 85.6% increase over 1998 figures

0

5

10

15

1970 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006Bil

lio

ns

of

do

llar

s sp

ent

Year

Federal Trade Commission (FTC). (2009). Cigarette Report for 2006.

New marketing restrictions

The TOBACCO INDUSTRY For decades, the tobacco industry 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: http://www.jeffreywigand.com/7ceos.php

Tobacco industry documents indicate otherwise Documents available at http://legacy.library.ucsf.edu

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…

an extra row of ventilation holes

Image courtesy of Mayo Clinic Nicotine Dependence Center - Research Program / Dr. Richard D. Hurt

The Marlboro and Marlboro Lights logos are registered trademarks of Philip Morris USA.

1932

4


19361990

SMOKING in MOVIES Cigarette smoking is pervasive in movies

Evident in at least ¾ of box-office hits Average, 10.9 smoking incidents per hour

Superman II (1980)

There is a dose-response, causal relationship between exposure to smoking in movies and youth smoking initiation

70% of adults support assigning an “R” rating to movies with smoking.

National Cancer Institute. (2008). The Role of the Media in Promoting and Reducing Tobacco Use.

For more information on smoking in movies, go to http://smokefreemovies.ucsf.edu

Charlesworth and Glantz. (2005). Pediatrics 116:1516–1528.

COMPOUNDS in TOBACCO SMOKE

Carbon monoxide Hydrogen cyanide Ammonia Benzene Formaldehyde

Nicotine Nitrosamines Lead Cadmium Polonium-210

An estimated 4,800 compounds in tobacco smoke, including 11 proven human carcinogens

Gases Particles

Nicotine is the addictive component of tobacco products, but it does NOT cause the ill health effects of tobacco use.

ANNUAL U.S. DEATHS ATTRIBUTABLE to SMOKING, 2000–2004

29%28%23%11%

8%<1%

Cardiovascular diseases 128,497Lung cancer 125,522Respiratory diseases 103,338Second-hand smoke 49,400Cancers other than lung 35,326Other 1,512

Percent of all smoking-attributable deaths

TOTAL: 443,595 deaths annually


ANNUAL SMOKING-ATTRIBUTABLE ECONOMIC COSTS

0 50 100 150 200

Health-care expenditures

Societal costs: $10.28 per pack of cigarettes smoked

Lost productivity costs

Total economic burden of smoking, per year

Billions of US dollars


Total Medicare program costs

Total federal-state Medicaid program costs

$96.7 billion

$97.6 billion

$30.9 billion

$18.9 billion

$194 billion

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2004 REPORT of the SURGEON GENERAL:HEALTH CONSEQUENCES OF SMOKING

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 (USDHHS). (2004).

The Health Consequences of Smoking: A Report of the Surgeon General.

FOUR MAJOR CONCLUSIONS:

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 (USDHHS). (2004).

The Health Consequences of Smoking: A Report of the Surgeon General.

HEALTH CONSEQUENCES of SMOKELESS TOBACCO USE

Periodontal effects Gingival recession Bone attachment loss Dental caries

Oral leukoplakia

Cancer Oral cancer Pharyngeal cancer Oral Leukoplakia

Image courtesy of Dr. Sol Silverman -University of California San Francisco HERMAN ® is reprinted with permission from

LaughingStock Licensing Inc., Ottawa, CanadaAll rights reserved.

U.S. Department of Health and Human Services (USDHHS). (2006).The Health Consequences of Involuntary Exposure to Tobacco Smoke: Report of the Surgeon General.

There is no safe level of second-hand

smoke.

Second-hand smoke causes premature death and disease in nonsmokers (children and adults)

Children: Increased risk for sudden infant death syndrome

(SIDS), acute respiratory infections, ear problems, and more severe asthma

2006 REPORT of the SURGEON GENERAL: INVOLUNTARY EXPOSURE to TOBACCO SMOKE

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

SMOKE-FREE WORKPLACE LAWS

Data current as of October 21, 2010.

Smoke-free offices, restaurants, and bars

Smoke-free restaurants and barsSmoke-free offices and restaurants

Smoke-free offices Smoke-free restaurantsNo statewide law

6


QUITTING: HEALTH BENEFITS

Lung cilia regain normal function

Ability to clear lungs of mucus increases

Coughing, fatigue, shortness of breath decrease

Excess risk of CHD decreases to half that of a

continuing smokerRisk of stroke is reduced to that of people who have never smoked

Lung cancer death rate drops to half that of a

continuing smoker

Risk of cancer of mouth, throat, esophagus,

bladder, kidney, pancreas decrease

Risk of CHD is similar to that of people who have never smoked

2 weeks to

3 months

1 to 9 months

1year

5years

10years

after15 years

Time Since Quit Date

Circulation improves, walking becomes easier

Lung function increases up to 30%

BENEFICIAL EFFECTS of QUITTING: PULMONARY EFFECTS

Reprinted with permission. Fletcher & Peto. (1977). BMJ 1(6077):1645–1648.

Disability

Death

Smokedregularly and

susceptible to effects of smoke

Never smoked or not susceptible to smoke

Stopped smoking at 45 (mild COPD)

Stopped smoking at 65 (severe COPD)

25

FE

V1

(% o

f va

lue

at a

ge

25)

25

50

75

100

0

50 75

Age (years)

COPD = chronic obstructive pulmonary disease

AT ANY AGE, there are benefits of quitting.

Reduction in cumulative risk of death from lung cancer in men

Reprinted with permission. Peto et al. (2000). BMJ 321(7257):323–329.

Cu

mu

lati

ve r

isk

(%)

Age in years

0

5

10

15

30 40 50 60

Yea

rs o

f lif

e g

aine

d

Age at cessation (years)

Prospective study of 34,439 male British doctors Mortality was monitored for 50 years (1951–2001)

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.

SMOKING CESSATION: REDUCED RISK of DEATH

Doll et al. (2004). BMJ 328(7455):1519–1527.

FINANCIAL IMPACT of SMOKING

Packsper day

Buying cigarettes every day for 50 years @ $5.95 per packMoney banked monthly, earning 2% interest

Dollars lost, in thousands

$755,177

$503,451

$251,725

0 200 400 600

$186,649

$373,298

$559,947

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. $193 billion per year. Lifetime financial costs of smoking approaches one million US dollars for a heavy smoker.

At any age, there are benefits to quitting smoking.

The biggest opponent to tobacco control efforts is the tobacco industry.

7


FORMS of TOBACCO

FORMS of TOBACCO Cigarettes

Smokeless tobacco (chewing tobacco, oral snuff)

Pipes

Cigars

Clove cigarettes

Bidis

Hookah (waterpipe smoking)

Electronic cigarettes (“e-cigarettes”)*

Image courtesy of the Centers for Disease Control and Prevention / Rick Ward

*e-cigarettes are devices that deliver nicotine and are not a form of tobacco.

AMERICAN CIGARETTES Most common form of tobacco used in U.S. Sold in packs (20 cigarettes/pack) Total nicotine content, per cigarette:

- Average 13.5 mg (range, 11.9 to 14.5 mg) Machine-measured nicotine yield:

Smoker’s nicotine yield, per cigarette:- Approximately 1 to 2 mg

Marlboro and Marlboro Light are registered trademarks of Philip Morris, Inc.

Type of cigarette Yield per cigarette

Full-flavor (regular) 1.1 mg

Light 0.8 mg

Ultra-light 0.4 mg

Average (all brands) 0.9 mg

SMOKELESS TOBACCO

Chewing tobacco Looseleaf Plug Twist

Snuff Moist Dry

The Copenhagen and Skoal logos are registered trademarks of U.S. Smokeless Tobacco Company, and Red Man is a registered trademark of Swedish Match.

SMOKELESS FORMS of TOBACCO

Estimated 8.6 million users in the U.S. in 2009 Males (6.7%) more likely than females (0.3%) to be current users Prevalence highest among

Young adults aged 18-25 years Residents of the Midwest and Southern U.S. Residents of nonmetropolitan areas

Significant health risks Numerous carcinogens Nicotine exposure comparable to that of smokers, leading to

Physical dependence Withdrawal symptoms after abstinence

NICOTINE CONTENT in SMOKELESS TOBACCO PRODUCTS

Dose Product pHTotal free nicotine (mg/g)

LowHawken Wintergreen 5.2 – 5.7 0.01 – 0.02

Skoal Bandits Wintergreen 6.9 – 7.1 0.5 – 1.0

Medium Skoal Long Cut Straight 7.5 – 7.6 2.4 – 3.7

HighKodiak Wintergreen 8.2 – 8.4 5.8 – 6.5

Copenhagen 7.6 – 8.6 3.1 – 9.4

Data from Hatsukami et al. (2007). Am J Prev Med 33(6S):S368–78.

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HEALTH CONSEQUENCES of SMOKELESS TOBACCO USE

Periodontal effects Gingival recession Bone attachment loss Dental caries

Oral leukoplakia

Cancer Oral cancer Pharyngeal cancer Oral Leukoplakia

Image courtesy of Dr. Sol Silverman -University of California San Francisco

PIPE TOBACCO

Prevalence of pipe smoking in the U.S. is less than 1%

Pipe smokers have an increased risk of death due to:

Cancer (lung, oral cavity, esophagus, larynx)

Chronic obstructive pulmonary disease

Risk of smoking tobacco-related death:cigarettes > pipes ≈ cigars

CIGARS

Estimated 13.3 million cigar smokers in the U.S. in 2009

Tobacco content of cigars varies greatly

One cigar can deliver enough nicotine to establish and maintain dependence

Cigar smoking is not a safe alternative to cigarette smoking

CLOVE CIGARETTES (also known as KRETEKS)

Mixture of tobacco and cloves

Imported from Indonesia

In 2010, an estimated 4.6% of 12th

graders in the U.S. reported smoking kreteks in the past year

Two times the tar and nicotine content of standard cigarettes

BIDIS

Imported from India

Resemble marijuana joints

Available in candy flavors

In 2010, an estimated 1.4% of 12th graders in the U.S. reported smoking bidis in the past year

Deliver 3-fold higher levels of carbon monoxide and nicotine and 5-fold higher levels of tar when compared to standard cigarettes

Image courtesy of the Centers for Disease Control and Prevention / Dr. Clifford H. Watson

HOOKAH (WATERPIPE SMOKING) Also known as

Shisha, Narghile, Goza, Hubble bubble

Tobacco flavored with fruit pulp, honey, and molasses

Increasingly popular among young adults in coffee houses, bars, and lounges An estimated 7-10% of U.S. college

students currently smoke hookah

Nicotine, tar and carbon monoxide levels comparable to or higher than those in cigarette smoke

Image courtesy of Mr. Sami Romman / www.hookah-shisha.com

9


ELECTRONIC CIGARETTES Battery operated devices that deliver vaporized nicotine

Cartridges contain nicotine, flavoring agents, and other chemicals

Battery warms cartridge; user inhales nicotine vapor or ‘smoke’

Available on-line and in shopping malls

Not labeled with health warnings

Preliminary FDA testing found some cartridges contain carcinogens and impurities (e.g., diethylene glycol)

No data to support claims that these products are a safe alternative to smoking

POTENTIALLY REDUCED-EXPOSURE PRODUCTS (PREPs)

Tobacco formulations altered to minimize exposure to harmful chemicals in tobacco Cigarette-like delivery devices

Eclipse, Heatbar

Oral noncombustible tobacco products Ariva, Marlboro Snus, Stonewall, Camel Snus

No evidence to prove that PREPs reduce the risk of developing tobacco-related disease

FORMS of TOBACCO: SUMMARY

Cigarettes are, by far, the most common form of tobacco used in the U.S.

Other forms of tobacco and nicotine delivery devices exist, and some are increasing in popularity.

All forms of tobacco are harmful.

The safety/efficacy of e-cigarettes is not established.

Attention to all forms of tobacco is needed.

NICOTINE PHARMACOLOGY and PRINCIPLES of ADDICTION

NICOTINE ADDICTIONU.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.

U.S. Department of Health and Human Services. (1988). The Health Consequences of Smoking: Nicotine Addiction. A Report of the Surgeon General.

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Nicotiana tabacumNatural liquid alkaloid

Colorless, volatile base pKa = 8.0

N

CH3N

H

Pyridine ring

Pyrrolidine ring

CHEMISTRY of NICOTINE PHARMACOLOGY

Effects of the body on the drug Absorption Distribution Metabolism Excretion

Effects of the drug on the body

Pharmacokinetics

Pharmacodynamics

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 (7.4), ~31% of nicotine is

nonionized

At physiologic pH,nicotine is readily absorbed.

NICOTINE ABSORPTION: BUCCAL (ORAL) MUCOSAThe pH inside the mouth is 7.0.

Acidic media(limited absorption)

Cigarettes

Alkaline media(significant absorption)

Pipes, cigars,spit tobacco,

oral nicotine products

Beverages can alter pH, affect absorption.

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 (20-45%) due to first-pass hepatic metabolism.

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

Approximately 1 mg of nicotine is absorbed from each cigarette.

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NICOTINE DISTRIBUTION

Henningfield et al. (1993). Drug Alcohol Depend 33:23–29.

0

10

20

30

40

50

60

70

80

0 1 2 3 4 5 6 7 8 9 10

Minutes after light-up of cigarette

Pla

sma

nico

tine

(ng

/ml) Arterial

Venous

Nicotine reaches the brain within 10–20 seconds.Metabolizedand excreted

in urine

NICOTINE METABOLISM

CH3N

H 10–20% excreted

unchangedin urine

Adapted and reprinted with permission. Benowitz et al. (1994). J Pharmacol Exp Ther 268:296–303.

70–80% cotinine

~ 10% other metabolites

N

NICOTINE EXCRETION

Half-life Nicotine t½ = 2 hr Cotinine t½ = 16 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.

Other:Neuromuscular junctionSensory receptorsOther organs

Central nervous system

Exocrine glands

Adrenal medulla

Peripheral nervous system

Gastrointestinal system

Cardiovascular system

Nicotine has predominantly stimulatory effects.

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

NEUROCHEMICAL and RELATED EFFECTS of NICOTINE

Dopamine

Norepinephrine

Acetylcholine

Glutamate

Serotonin

-Endorphin

GABA

N

I

C

O

T

I

N

E

Pleasure, appetite suppression

Arousal, appetite suppression

Arousal, cognitive enhancement

Learning, memory enhancement

Mood modulation, appetite suppression

Reduction of anxiety and tension

Reduction of anxiety and tension

Benowitz. (2008). Clin Pharmacol Ther 83:531–541.

12


WHAT IS ADDICTION?

”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

BIOLOGY of NICOTINE ADDICTION: ROLE of DOPAMINENicotine

stimulates dopamine release

Repeat administration

Tolerance develops

Discontinuation leads towithdrawal symptoms.Pleasurable feelings

Nicotine addiction is not just a bad habit.


Nicotine entersbrain

Stimulation of nicotine receptors

Dopamine release

DOPAMINE REWARD PATHWAYPrefrontal

cortex

Nucleus accumbens

Ventral tegmental

area

CHRONIC ADMINISTRATION of NICOTINE: EFFECTS on the BRAIN

Perry et al. (1999). J Pharmacol Exp Ther 289:1545–1552.

Nonsmoker Smoker

Human smokers have increased nicotine receptors in the prefrontal cortex.

High

Low

Image courtesy of George Washington University / Dr. David C. Perry

Irritability/frustration/anger

Anxiety

Difficulty concentrating

Restlessness/impatience

Depressed mood/depression

Insomnia

Impaired performance

Increased appetite/weight gain

Cravings

NICOTINE PHARMACODYNAMICS: WITHDRAWAL EFFECTS

Hughes. (2007). Nicotine Tob Res 9:315–327.

Most symptoms manifest within the first 1–2 days,

peak within the first week, and subside within

2–4 weeks.

HANDOUT

NICOTINE ADDICTION CYCLE

Reprinted with permission. Benowitz. (1992). Med Clin N Am 2:415–437.

13


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


ASSESSINGNICOTINE 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

Heatherton et al. (1991). British Journal of Addiction 86:1119–1127.

HANDOUT

CLOSE TO HOME © 2000 John McPherson. Reprinted with permission of UNIVERSAL PRESS SYNDICATE.

All rights reserved.

FACTORS CONTRIBUTING toTOBACCO USE

Physiology Age, sex Genetic predisposition Coexisting medical

conditions

Environment Tobacco advertising Conditioned stimuli Social interactions

Pharmacology Alleviation of withdrawal

symptoms Weight control Pleasure, mood modulation

Tobacco Use

TOBACCO DEPENDENCE:A 2-PART PROBLEM

Tobacco Dependence

Treatment should address the physiological and the behavioral aspects of dependence.

Physiological Behavioral

Treatment Treatment

The addiction to nicotine

Medications for cessation

The habit of using tobacco

Behavior change program

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 self-regulate tobacco intake to maintain pleasurable effects and prevent withdrawal.

14


NICOTINE PHARMACOLOGY and ADDICTION: SUMMARY (cont’d)

Nicotine dependence is a chronic disorder.

Tobacco use is complex, involving the interplay of the following:

Pharmacology of nicotine (pharmacokinetics and pharmacodynamics)

Environmental factors

Physiologic factors

Treatment of tobacco use and dependence requires a multifaceted treatment approach.

DRUG INTERACTIONS with SMOKING

PHARMACOKINETIC DRUG INTERACTIONS with SMOKING

Drugs that may have a decreased effect due to induction of CYP1A2:

Bendamustine Olanzapine Caffeine Ropinirole Clozapine Tacrine Erlotinib Theophylline Fluvoxamine Irinotecan (clearance increased and systemic exposure decreased,

due to increased glucuronidation of its active metabolite)

Smoking cessation will reverse these effects.

HANDOUT

PHARMACOKINETIC DRUG INTERACTIONS with SMOKING, cont’d

Drug that might have an increased effect and efficacy due to induction of CYP1A2:

Clopidogrel

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 the combustion products of

tobacco smoke, not from nicotine.

Constituents in tobacco smoke (e.g., polycyclic aromatic hydrocarbons; PAHs) may enhance the metabolism of other drugs, resulting in an altered pharmacologic response.

Smoking might adversely affect the clinical response to the treatment of a wide variety of conditions.

Drug interactions with smoking should be considered when patients start smoking, quit smoking, or markedly alter their levels of smoking.

15


ASSISTING PATIENTS with QUITTING

Update released May 2008

Sponsored by the U.S. Department of Health and Human Services, Public Heath Service with: Agency for Healthcare Research and Quality National Heart, Lung, & Blood Institute National Institute on Drug Abuse Centers for Disease Control and Prevention National Cancer Institute

www.surgeongeneral.gov/tobacco/

CLINICAL PRACTICE GUIDELINE for TREATING TOBACCO USE and DEPENDENCE

HANDOUT

EFFECTS of CLINICIAN INTERVENTIONS

0

10

20

30

No clinician Self-helpmaterial

Nonphysicianclinician

Physicianclinician

Type of Clinician

Esti

mat

ed a

bsti

nenc

e at

5+

mon

ths

1.0 1.11.7

2.2

n = 29 studies

Fiore et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: USDHHS, PHS, May 2008.

With help from a clinician, the odds of quitting approximately doubles.

Compared to patients who receive no assistance from a clinician, patients who receive assistance are 1.7–2.2 times as likely to quit successfully for 5 or more months.

Esti

mat

ed a

bsti

nen

ce r

ate

at 5

+ m

onth

s

0

10

20

30

None One Two Three or more

Number of Clinician Types

1.0

1.8(1.5,2.2)

2.5(1.9,3.4)

2.4(2.1,3.4)

n = 37 studies

NUMBER of CLINICIAN TYPES CAN MAKE a DIFFERENCE, too

Compared to smokers who receive assistance from no clinicians, smokers who receive assistance from two or more clinician types are 2.4–2.5 times as likely to quit successfully for 5 or more months.


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).

Barzilai et al. (2001). Prev Med 33:595–599.

Failure to address tobacco use tacitly implies that quitting is not important.

WHY SHOULD CLINICIANS ADDRESS TOBACCO?

ASK

ADVISE

ASSESS

ASSIST

ARRANGE

The 5 A’s

HANDOUT


16


The 5 A’s (cont’d)

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.”

“Condition X often is caused or worsened by smoking. Do you, or does someone in your household smoke?”

“Medication X often is used for conditions linked with or caused by smoking. Do you, or does someone in your household smoke?”

ASK tobacco users to quit (clear, strong, personalized) “It’s important that you quit as soon as possible, and I can help

you.”

“Cutting down while you are ill is not enough.”

“Occasional or light smoking is still harmful.”

“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.”

ADVISE



Assess readiness to make a quit attemptASSESS

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

ASSIST

Arrange follow-up careARRANGE


Number of sessions Estimated quit rate*

0 to 1 12.4%2 to 3 16.3%4 to 8 20.9%

More than 8 24.7%* 5 months (or more) postcessation

Provide assistance throughout the quit attempt.Fiore et al. (2008). Treating Tobacco Use and Dependence: 2008 Update.

Clinical Practice Guideline. Rockville, MD: USDHHS, PHS, May 2008.

The 5 A’s: REVIEW

ASK about tobacco USE

ADVISE tobacco users to QUIT

ASSESS READINESS to make a quit attempt

ASSIST with the QUIT ATTEMPT

ARRANGE 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?

The (DIFFICULT) DECISION to QUIT

17


HELPING PATIENTS QUIT IS a CLINICIAN’S RESPONSIBILITY

THE DECISION TO QUIT LIES IN THE HANDS OF EACH PATIENT.

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.

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 READINESS to QUIT

Patients differ in their readiness to quit.

Assessing a patient’s readiness to quit enables clinicians to deliver relevant, appropriate counseling messages.

Former tobacco

user

Recent quitter

Ready to quit

Not ready to quit

Relapse

Not thinking about it

Thinking about it, not ready

For most patients, quitting is a cyclical process, and their readiness to quit (or stay quit) will change over time.

Assess readiness to quit (or to stay quit) at each patient

contact.

ASSESSING READINESS to QUIT (cont’d) IS a PATIENT READY to QUIT?

Does the patient now use tobacco?

Is the patient now ready to quit?

Provide treatmentThe 5 A’s

Enhance motivation

Yes

YesNo

Did the patient once use tobacco?

Prevent relapse*

Encourage continued abstinence

Yes

No

No

*Relapse prevention interventions not necessary if patient has not used tobacco for many years and is not at risk for re-initiation.


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.

ASSESSING READINESS to QUIT (cont’d)

STAGE 1: NOT READY to QUITCounseling Strategies

DON’T Persuade

“Cheerlead”

Tell patient how bad tobacco is, in a judgmental manner

Provide a treatment plan

DO Strongly advise to quit

Provide information Ask noninvasive questions;

identify reasons for tobacco use

Raise awareness of health consequences/concerns

Demonstrate empathy, foster communication

Leave decision up to patient

18


Consider asking:

“Do you ever plan to quit?”

“What might be some of the benefits of quitting now, instead of later?”

“What would have to change for you to decide to quit sooner?”

STAGE 1: NOT READY to QUITCounseling Strategies (cont’d)

If YESIf NO

Advise patients to quit, and offer to assist (if or when they change their mind).

Most patients will agree: there is no “good” time to quit, and there are benefits to quitting sooner as opposed to later.

Responses will reveal some of the barriers to quitting.

The 5 R’s—Methods for enhancing motivation:

Relevance

Risks

Rewards

Roadblocks

Repetition

Tailored, motivational messages

STAGE 1: NOT READY to QUITCounseling Strategies (cont’d)


STAGE 1: NOT READY to QUITA Demonstration

CASE SCENARIO:Ms. Lilly Vitale

You are a clinician providing care to Ms. Vitale, a young woman with early-stage emphysema.

VIDEO # V6a

Ready to quit in the next month Patients are aware of the need to, and the benefits

of, making the behavioral change.

Patients are getting ready to take action.

STAGE 2: Ready to quit

GOAL: Achieve cessation.


Assess tobacco use history

Discuss key issues

Facilitate quitting process

Practical counseling (problem solving/skills training)

Social support delivered as part of treatment

STAGE 2: READY to QUITThree Key Elements of Counseling

STAGE 2: READY to QUITAssess Tobacco Use History

Praise the patient’s readiness Assess tobacco use history

Current use: type(s) of tobacco, amount Past use: duration, recent changes Past quit attempts:

Number, date, length Methods used, compliance, duration Reasons for relapse

19


Reasons/motivation to quit Confidence in ability to quit 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

STAGE 2: READY to QUITDiscuss Key Issues

When drinking coffee While driving in the car When bored or stressed While watching television While at a bar with friends

After meals or after sex During breaks at work While on the telephone While with specific friends or family

members who use tobacco

“Smoking gets rid of all my stress.”

“I can’t relax without a cigarette.”

There will always be stress in one’s life.

There are many ways to relax without a cigarette.

THE MYTHS

STRESS MANAGEMENT SUGGESTIONS:Deep breathing, shifting focus, taking a break.

Smokers confuse the relief of withdrawal with the feeling of relaxation.

STAGE 2: READY to QUITDiscuss Key Issues (cont’d)

THE FACTS

Stress-Related Tobacco Use

HERMAN ® is reprinted with permission from LaughingStock Licensing Inc., Ottawa, Canada


Most smokers gain fewer than 10 pounds, but there is a wide range.

Discourage strict dieting while quitting Encourage healthful diet and meal planning Suggest increasing water intake or chewing sugarless gum Recommend selection of nonfood rewards

When fear of weight gain is a barrier to quitting Consider pharmacotherapy with evidence of delaying weight

gain (bupropion SR or 4-mg nicotine gum or lozenge)

Assist patient with weight maintenance or refer patient to specialist or program


Concerns about Weight Gain

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 HANDOUT


Concerns about Withdrawal Symptoms

Most symptoms manifest within the

first 1–2 days, peak within the first week, and

subside within 2–4 weeks.

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 Recommend Tobacco Use Log

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

STAGE 2: READY to QUITFacilitate Quitting Process

HANDOUT

20


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)

Review log to identify situational triggers for tobacco use; develop patient-specific coping strategies

STAGE 2: READY to QUITFacilitate Quitting Process (cont’d)

Tobacco Use Log: Instructions for use Discuss coping strategies

Cognitive coping strategies Focus on retraining the way a patient thinks

Behavioral coping strategies

Involve specific actions to reduce risk for relapse


HANDOUT

Review commitment to quit

Distractive thinking

Positive self-talk

Relaxation through imagery

Mental rehearsal and visualization

Cognitive Coping Strategies


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.”

Cognitive Coping Strategies: Examples


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

Behavioral Coping Strategies


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!


21


STAGE 2: READY to QUITA Demonstration

CASE SCENARIO:Ms. Staal

You are a clinician providing care to Ms. Staal, a 44-year old woman in the emergency room with pulmonary distress.

VIDEO # V17a

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.

STAGE 3: Recent quitter

GOAL: Remain tobacco-free for at least 6 months.




STAGE 3: RECENT QUITTERSEvaluate 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 adherence, 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 provided as part of treatment Schedule additional follow-up as needed

STAGE 3: RECENT QUITTERSFacilitate Quitting Process

Relapse Prevention

STAGE 3: RECENT QUITTERA Demonstration

CASE SCENARIO:Mr. Angelo Fleury

You are a clinician providing follow-up care to Mr. Angelo Fleury, who recently quit and is experiencing difficulty sleeping and coping with job-related stress.

VIDEO # V25b

22


Tobacco-free for 6 months Patients remain vulnerable to relapse.

Ongoing relapse prevention is needed.

STAGE 4: Former tobacco user

GOAL: Remain tobacco-free for life.




STAGE 4: FORMER TOBACCO USERS

Assess status of quit attempt

Slips and relapse

Medication compliance, plans for termination Has pharmacotherapy been terminated?

Continue to offer tips for relapse prevention

Encourage healthy behaviors

Congratulate continued success

Continue to assist throughout the quit attempt.

READINESS to QUIT: A REVIEW

Recent quitterNot ready to quit Former tobacco user

Quit date

Ready to quit

- 30 days + 6 months

Enhance motivation

The 5 R’s

Behavioral counseling

Pharmacotherapy

The 5 A’s


Relapse prevention


Pharmacotherapy

Relapse prevention

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

COMPREHENSIVE COUNSELING: SUMMARY

ASK about tobacco USE

ADVISE tobacco users to QUIT

REFER to other resources

ASSIST

ARRANGE

BRIEF COUNSELING: ASK, ADVISE, REFER

Patient receives assistance from other resources, with

follow-up counseling arranged

23


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 group programs or the toll-free quitline1-800-QUIT-NOW

BRIEF COUNSELING: ASK, ADVISE, REFER (cont’d)

This brief intervention can be

achieved in less than 1 minute.

WHAT ARE “TOBACCO QUITLINES”?

Tobacco cessation counseling, provided at no cost via telephone to all Americans

Staffed by trained specialists Up to 4–6 personalized sessions (varies by state) Some state quitlines offer pharmacotherapy at no

cost (or reduced cost) Up to 30% success rate for patients who complete

sessions

Most health-care providers, and most patients, are not familiar with tobacco quitlines.

Counselor or Intake Specialist Answers Caller is routed to language-appropriate staff

Brief Questionnaire Contact and demographic information Smoking behavior (e.g., cigarettes per day) Choice of services

WHEN a PATIENT CALLS the QUITLINE

Services provided Referral to local programs Quitting literature mailed within 24 hrs Individualized telephone counseling

Confidential Professional, trained counselors

WHEN a PATIENT CALLS the QUITLINE (cont’d)

Quitlines have broad reach and are recommended as an effective strategy in the 2008 Clinical Practice Guideline.

Address tobacco use with all patients.

At a minimum,make a commitment to incorporate brief tobacco interventions as part of routine patient care.

Ask, Advise, and Refer.

MAKE a COMMITMENT… WHAT IF…

a patient asks you about your use of tobacco?

24


Courtesy of Mell Lazarus and Creators Syndicate. Copyright 2000, Mell Lazarus.

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 ofTHERAPY.

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.”

USDHHS. (2001). Women and Smoking: A Report of the Surgeon General. Washington, DC: PHS.

AIDS for CESSATION

METHODS for QUITTING

Nonpharmacologic Counseling and other non-drug approaches

Pharmacologic FDA-approved medications

Counseling and medications are both effective, but the combination of counseling and

medication is more effective than either alone.Fiore et al. (2008). Treating Tobacco Use and Dependence: 2008 Update.

Clinical Practice Guideline. Rockville, MD: USDHHS, PHS, May 2008.

NONPHARMACOLOGIC METHODS

Cold turkey: Just do it!

Unassisted tapering (fading) Reduced frequency of use Lower nicotine cigarettes Special filters or holders

Assisted tapering QuitKey (PICS, Inc.)

Computer developed taper based on patient’s smoking level

Includes telephone counseling support

25


NONPHARMACOLOGIC METHODS (cont’d)

Formal cessation programs Self-help programs Individual counseling Group programs Telephone counseling

1-800-QUITNOW 1-800-786-8669

Web-based counseling www.smokefree.gov www.quitnet.com www.becomeanex.org

Acupuncture therapy

Hypnotherapy

Massage therapy

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

PHARMACOTHERAPY


Medications significantly improve success rates.* Includes pregnant women, smokeless tobacco users, light smokers, and adolescents.

“Clinicians should encourage all patients attempting to quit to use effective medications for tobacco dependence treatment, except where contraindicated or for specific populations* for which there is insufficient evidence of effectiveness.”

PHARMACOTHERAPY: USE in PREGNANCY

The Clinical Practice Guideline makes no recommendation regarding use of medications in pregnant smokers Insufficient evidence of effectiveness

Category C: varenicline, bupropion SR

Category D: prescription formulations of NRT

“Because of the serious risks of smoking to the pregnant smoker and the fetus, whenever possible pregnant smokers should be offered person-to-person psychosocial interventions that exceed minimal advice to quit.” (p. 165)


PHARMACOTHERAPY: OTHER SPECIAL POPULATIONS

Pharmacotherapy is not recommended for: Smokeless tobacco users

No FDA indication for smokeless tobacco cessation

Individuals smoking fewer than 10 cigarettes per day

Adolescents Nonprescription sales (patch, gum, lozenge) are restricted to

adults ≥18 years of age NRT use in minors requires a prescription


Recommended treatment is behavioral counseling.

NRT: RATIONALE for USE

Reduces physical withdrawal from nicotine

Eliminates the immediate, reinforcing effects of nicotine that is rapidly absorbed via tobacco smoke

Allows patient to focus on behavioral and psychological aspects of tobacco cessation

NRT products approximately doubles quit rates.

26


Polacrilex gum Nicorette (OTC) Generic nicotine gum (OTC)

Lozenge Nicorette Lozenge (OTC) Nicorette Mini Lozenge (OTC) Generic nicotine lozenge (OTC)

Transdermal patch NicoDerm CQ (OTC) Generic nicotine patches (OTC, Rx)

Nasal spray Nicotrol NS (Rx)

Inhaler Nicotrol (Rx)

NRT: PRODUCTS

Patients should stop using all forms of tobacco upon initiation of the NRT regimen.

PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS

0

5

10

15

20

25

1/0/1900 1/10/1900 1/20/1900 1/30/1900 2/9/1900 2/19/1900 2/29/1900

Pla

sma

nic

oti

ne

(mcg

/l)

Cigarette

Moist snuff

Nasal spray

Inhaler

Lozenge (2mg)

Gum (2mg)

Patch

0 10 20 30 40 50 60

Time (minutes)

Cigarette

Moist snuff

NRT: PRECAUTIONS

Patients with underlying cardiovascular disease Recent myocardial infarction (within past 2

weeks)

Serious arrhythmias Serious or worsening angina

NRT products may be appropriate for these patients if they are under medical supervision.

Resin complex Nicotine Polacrilin

Sugar-free chewing gum base

Contains buffering agents to enhance buccal absorption of nicotine

Available: 2 mg, 4 mg; original, cinnamon, fruit, mint (various), and orange flavors

NICOTINE GUMNicorette (GlaxoSmithKline); generics

NICOTINE GUM: DOSING Dosage is based on the “time to first cigarette” (TTFC) as an indicator of nicotine dependence

Use the 2 mg gum:If you smoke your first cigarette more than 30 minutes after waking

Use the 4 mg gum:If you smoke your first cigarette of the day within 30 minutes of waking

NICOTINE GUM: DOSING (cont’d)

Recommended Usage Schedule for Nicotine Gum

Weeks 1–6 Weeks 7–9 Weeks 10–12

1 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.

27


NICOTINE GUM:DIRECTIONS for USE

Chew each piece very slowly several times

Stop chewing at first sign of peppery 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

Park between cheek & gum

Stop chewing at first sign of peppery taste or tingling sensation

Chew slowly

Chew again when peppery taste or tingle fades

NICOTINE GUM: ADDITIONAL PATIENT EDUCATION

To improve chances of quitting, use at least nine pieces of gum daily

The effectiveness of nicotine gum 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 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 and 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

NICOTINE GUM: SUMMARYDISADVANTAGES Need for frequent dosing can

compromise compliance.

Might be problematic for patients with significant dental work.

Patients must use proper chewing technique to minimize adverse effects.

Gum chewing might not be socially acceptable.

ADVANTAGES Might satisfy oral

cravings.

Might delay weight gain (4-mg strength).

Patients can titrate therapy to manage withdrawal symptoms.

A variety of flavors are available.

28


NICOTINE LOZENGENicorette Lozenge and Nicorette Mini Lozenge (GlaxoSmithKline); generics

Nicotine polacrilex formulation Delivers ~25% more nicotine

than equivalent gum dose

Sugar-free mint, cherry flavors

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 dependence

Use the 2 mg lozenge:If you smoke your first cigarette more than 30 minutes after waking

Use the 4 mg lozenge:If you smoke your first cigarette of the day within 30 minutes of waking

NICOTINE LOZENGE: DOSING (cont’d)

Recommended Usage Schedule for theNicotine Lozenge

Weeks 1–6 Weeks 7–9 Weeks 10–12

1 lozengeq 1–2 h

1 lozengeq 2–4 h

1 lozengeq 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.

Standard lozenges will dissolve completely in about 2030 minutes; Nicorette Mini lozenge will dissolve in 10 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.

NICOTINE LOZENGE:ADD’L PATIENT EDUCATION (cont’d)

Side effects of the nicotine lozenge include Nausea Hiccups

Cough Heartburn Headache

Flatulence Insomnia

29


NICOTINE LOZENGE: SUMMARYDISADVANTAGES Need for frequent dosing

can compromise compliance

Gastrointestinal side effects (nausea, hiccups, and heartburn) may be bothersome.

ADVANTAGES Might satisfy oral cravings.

Might delay weight gain (4-mg strength).

Easy to use and conceal.

Patients can titrate therapy to manage withdrawal symptoms.

Several flavors are available.

TRANSDERMAL NICOTINE PATCHNicoDerm CQ (GlaxoSmithKline); generic

Nicotine is well absorbed across the skin

Delivery to systemic circulation avoids hepatic first-pass metabolism

Plasma nicotine levels are lower and fluctuate less than with smoking

TRANSDERMAL NICOTINE PATCH:PREPARATION COMPARISON

Product NicoDerm CQ Generic

Nicotine delivery

24 hours 24 hours

Availability OTC Rx/OTC

Patch strengths 7 mg14 mg21 mg

7 mg14 mg21 mg

TRANSDERMAL NICOTINE PATCH: DOSING

Product Light Smoker Heavy Smoker

NicoDerm CQ 10 cigarettes/day

Step 2 (14 mg x 6 weeks)


>10 cigarettes/day




Generic

(formerly Habitrol)

10 cigarettes/day



>10 cigarettes/day




TRANSDERMAL NICOTINE PATCH:DIRECTIONS for USE

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

TRANSDERMAL NICOTINE PATCH:DIRECTIONS for USE (cont’d)

Remove patch from protective pouch Peel off half of the backing from patch

30



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


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

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

DISADVANTAGES

Patients cannot titrate the dose to acutely manage withdrawal symptoms.

Allergic reactions to the adhesive may occur.

Patients with dermatologic conditions should not use the patch.

ADVANTAGES

Provides consistent nicotine levels.

Easy to use and conceal.

Once daily dosing associated with fewer compliance problems.

31


NICOTINE NASAL SPRAYNicotrol NS (Pfizer)

Aqueous solution of nicotine in a 10-ml spray bottle

Each metered dose actuation delivers 50 mcL 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) Re-prime (1-2 sprays) if spray not used for

24 hours

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

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

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NICOTINE NASAL SPRAY:SUMMARY

DISADVANTAGES Need for frequent dosing

can compromise compliance. Nasal/throat irritation may

be bothersome. Higher dependence

potential. Patients with chronic nasal

disorders or severe reactive airway disease should not use the spray.

ADVANTAGES Patients can easily

titrate therapy to rapidly manage withdrawal symptoms.

NICOTINE INHALERNicotrol Inhaler (Pfizer)

Nicotine inhalation system consists of: Mouthpiece Cartridge with porous plug

containing 10 mg nicotine and 1 mg menthol

Delivers 4 mg nicotine vapor, absorbed across buccal mucosa

NICOTINE INHALER: DOSING

Start with at least 6 cartridges/day during the first 3-6 weeks of treatment

Increase prn to maximum of 16 cartridges/day

In general, use 1 cartridge every 1-2 hours

Recommended duration of therapy is 3 months

Gradually reduce daily dosage over the following 6–12 weeks

Air in

Aluminum laminatesealing material

Porous plug impregnated with nicotine

Mouthpiece

Nicotine cartridge

Air/nicotine mixture out

Sharp point that breaks the seal

Sharp point that breaks the seal

NICOTINE INHALER:SCHEMATIC DIAGRAM

Reprinted with permission from Schneider et al. (2001). Clinical Pharmacokinetics 40:661–684. Adis International, Inc.

NICOTINE INHALER:DIRECTIONS for USE

Align marks on the mouthpiece

NICOTINE INHALER:DIRECTIONS for USE (cont’d)

Pull and separate mouthpiece into two parts

33



Press nicotine cartridge firmly into bottom of mouthpiece until seal breaks


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

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


NICOTINE INHALER:ADDITIONAL PATIENT EDUCATION

Side effects associated with the nicotine inhaler include: Mild irritation of the mouth or throat

Cough

Headache

Rhinitis

Dyspepsia

Severity generally rated as mild, and frequency of symptoms declined with continued use

NICOTINE INHALER:ADD’L PATIENT EDUCATION (cont’d)

The inhaler may not be as effective in very cold (<59F) 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.

NICOTINE INHALER: SUMMARYDISADVANTAGES Need for frequent dosing can

compromise compliance. 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.

ADVANTAGES Patients can easily titrate

therapy to manage withdrawal symptoms.

The inhaler mimics the hand-to-mouth ritual of smoking.

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BUPROPION SRZyban (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)

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)

Neuropsychiatric symptoms and suicide risk

Changes in mood (depression and mania)

Psychosis/hallucinations/paranoia/delusions

Homicidal ideation/hostility

Agitation/anxiety/panic

Suicidal ideation or attempts

Completed suicide

BUPROPION:WARNINGS and PRECAUTIONS

Patients should stop bupropion and contact a health care provider immediately if agitation, hostility, depressed mood or changes in

thinking or behavior (including suicidal ideation) are observed

BUPROPION:WARNINGS and PRECAUTIONS (cont’d)

Bupropion should be used with 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

Patients with depressive or psychiatric disorders

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BUPROPION SR: DOSING

Initial treatment 150 mg po q AM x 3 days

Then… 150 mg po bid Duration, 7–12 weeks

Patients should begin therapy 1 to 2 weeks PRIOR to their quit date to ensure that therapeutic plasma

levels of the drug are achieved.

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

BUPROPION SR: SUMMARYDISADVANTAGES The seizure risk is

increased.

Several contraindications and precautions preclude use in some patients.

ADVANTAGES Easy to use oral

formulation.

Twice daily dosing might reduce compliance problems.

Might delay weight gain

Bupropion might be beneficial for patients with depression.

VARENICLINE Chantix (Pfizer)

Nonnicotine cessation aid

Partial nicotinic receptor agonist

Oral formulation

VARENICLINE:MECHANISM of ACTION

Binds with high affinity and selectivity at 42neuronal 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

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VARENICLINE:PHARMACOKINETICS

Absorption

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

Neuropsychiatric Symptoms and Suicidality

Changes in mood (depression and mania)

Psychosis/hallucinations/paranoia/delusions

Homicidal ideation/hostility

Agitation/anxiety/panic

Suicidal ideation or attempts

Completed suicide

VARENICLINE:WARNINGS and PRECAUTIONS

Patients should stop varenicline and contact a health care provider immediately if agitation, hostility, depressed mood or changes in

thinking or behavior (including suicidal ideation) are observed

VARENICLINE:WARNINGS and PRECAUTIONS (cont’d)

Cardiovascular adverse events in patients with existing cardiovascular disease

Hypersensitivity reactions

Serious skin reactions

Accidental injury

Nausea

VARENICLINE: DOSINGPatients should begin therapy 1 week PRIOR to theirquit date. The dose is gradually increased to minimize

treatment-related nausea and insomnia.

Treatment Day Dose

Day 1 to day 3 0.5 mg qd

Day 4 to day 7 0.5 mg bid

Day 8 to end of treatment* 1 mg bid

Initial dose titration

* Up to 12 weeks

VARENICLINE:ADVERSE EFFECTS

Common (≥5% and 2-fold higher than placebo) Nausea Sleep disturbances (insomnia, abnormal dreams) Constipation Flatulence Vomiting

VARENICLINE: ADDITIONAL PATIENT EDUCATION

Doses should be taken after eating, with a full glass of water

Nausea and insomnia are usually temporary side effects

If symptoms persist, notify your health care provider

May experience vivid, unusual or strange dreams during treatment

Use caution driving or operating machinery until effects of quitting smoking with varenicline are known

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VARENICLINE: ADDITIONAL PATIENT EDUCATION (cont’d)

Stop taking varenicline and contact a health-care provider immediately if agitation, depressed mood, suicidal thoughts or changes in behavior are noted

Stop taking varenicline at the first sign of rash with mucosal lesions and contact a health-care provider immediately

Discontinue varenicline and seek immediate medical care if swelling of the face, mouth (lip, gum, tongue) and neck are noted

VARENICLINE: SUMMARYDISADVANTAGES May induce nausea in up to

one third of patients.

Post-marketing surveillance data indicate potential for neuropsychiatric symptoms.

ADVANTAGES Easy to use oral

formulation.

Twice daily dosing might reduce compliance problems.

Offers a new mechanism of action for persons who have failed other agents.

PHARMACOLOGIC METHODS: SECOND-LINE THERAPIES

Clonidine (Catapres transdermal or oral)

Nortriptyline (Pamelor oral)

HERBAL DRUGS for SMOKING CESSATION

Lobeline Derived from leaves of Indian

tobacco plant (Lobelia inflata)

Partial nicotinic agonist

No scientifically rigorous trials with long-term follow-up

No evidence to support use for smoking cessation

Illustration courtesy of Missouri Botanical Garden ©1995-2005. http://www.illustratedgarden.org/

LONG-TERM (6 month) QUIT RATES for AVAILABLE CESSATION MEDICATIONS

0

5

10

15

20

25

30

Nicotine gum Nicotinepatch

Nicotinelozenge

Nicotinenasal spray

Nicotineinhaler

Bupropion Varenicline

Active drug

Placebo

Data adapted from Cahill et al. (2008). Cochrane Database Syst Rev; Stead et al. (2008). Cochrane Database Syst Rev; Hughes et al. (2007). Cochrane Database Syst Rev

Per

cen

t q

uit 18.0

15.8

11.3

9.9

16.1

8.1

23.9

11.8

17.1

9.1

19.0

10.3 11.2

20.2

COMBINATION PHARMACOTHERAPY

Combination NRT

Long-acting formulation (patch)

Produces relatively constant levels of nicotine

PLUS

Short-acting formulation (gum, inhaler, nasal spray)

Allows for acute dose titration as needed for nicotine withdrawal symptoms

Bupropion SR + Nicotine Patch

Regimens with enough evidence to be ‘recommended’ first-line

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COMPLIANCE IS KEY to QUITTING

Promote compliance with prescribed regimens.

Use according to dosing schedule, NOT as needed.

Consider telling the patient: “When you use a cessation product it is important to read all

the directions thoroughly before using the product. The products work best in alleviating withdrawal symptoms when used correctly, and according to the recommended dosing schedule.”

Gum Lozenge Patch Inhaler Nasal sprayBupropion

SR Varenicline

Trade $4.41 $4.95 $3.52 $7.68 $4.43 $7.46 $6.20Generic $2.25 $2.61 $1.87 $3.62

$0

$1

$2

$3

$4

$5

$6

$7

$8

$9

COMPARATIVE DAILY COSTS of PHARMACOTHERAPY

$/da

y

Average $/pack of cigarettes, $5.58

SUMMARY To maximize success, interventions should include counseling

and one or more medications

Clinicians should encourage the use of effective medications by all patients attempting to quit smoking Exceptions include medical contraindications or use in specific

populations for which there is insufficient evidence of effectiveness

First-line medications that reliably increase long-term smoking cessation rates include: Bupropion SR Nicotine replacement therapy (gum, inhaler, lozenge, patch, nasal spray)

Varenicline

Use of effective combinations of medications should be considered

“CIGARETTE SMOKING… 2... · World Health Organization Report on the Global Tobacco Epidemic...

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