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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
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Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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%
Centers for Disease Control and Prevention (CDC). (2011). MMWR 60:1207–1212.
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
Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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
Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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
Centers for Disease Control and Prevention (CDC). (2008). MMWR 57:1226–1228.
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
Centers for Disease Control and Prevention (CDC). (2008). MMWR 57:1226–1228.
Total Medicare program costs
Total federal-state Medicaid program costs
$96.7 billion
$97.6 billion
$30.9 billion
$18.9 billion
$194 billion
5
Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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
Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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
Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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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Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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
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Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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.
10
Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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.
11
Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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
Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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.
Benowitz. (2008). Clin Pharmacol Ther 83:531–541.
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
Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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
Benowitz. (2008). Clin Pharmacol Ther 83:531–541.
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
Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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
Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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.
Fiore et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: USDHHS, PHS, May 2008.
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
Fiore et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: USDHHS, PHS, May 2008.
16
Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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
The 5 A’s (cont’d)
The 5 A’s (cont’d)
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
The 5 A’s (cont’d)
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
Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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.
Fiore et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: USDHHS, PHS, May 2008.
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
Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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)
Fiore et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: USDHHS, PHS, May 2008.
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.
ASSESSING READINESS to QUIT (cont’d)
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
Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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
All rights reserved.
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
STAGE 2: READY to QUITDiscuss Key Issues (cont’d)
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
STAGE 2: READY to QUITDiscuss Key Issues (cont’d)
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
Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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
STAGE 2: READY to QUITFacilitate Quitting Process (cont’d)
HANDOUT
Review commitment to quit
Distractive thinking
Positive self-talk
Relaxation through imagery
Mental rehearsal and visualization
Cognitive Coping Strategies
STAGE 2: READY to QUITFacilitate Quitting Process (cont’d)
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
STAGE 2: READY to QUITFacilitate Quitting Process (cont’d)
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
STAGE 2: READY to QUITFacilitate 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!
STAGE 2: READY to QUITFacilitate Quitting Process (cont’d)
21
Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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.
ASSESSING READINESS to QUIT (cont’d)
HERMAN ® is reprinted with permission from LaughingStock Licensing Inc., Ottawa, Canada
All rights reserved.
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
Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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.
ASSESSING READINESS to QUIT (cont’d)
HERMAN ® is reprinted with permission from LaughingStock Licensing Inc., Ottawa, Canada
All rights reserved.
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
Behavioral counseling
Relapse prevention
Behavioral counseling
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
Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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
Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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
Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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
Fiore et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: USDHHS, PHS, May 2008.
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)
Fiore et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: USDHHS, PHS, May 2008.
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
Fiore et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: USDHHS, PHS, May 2008.
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
Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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
Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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
Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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
Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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)
Step 3 (7 mg x 2 weeks)
>10 cigarettes/day
Step 1 (21 mg x 6 weeks)
Step 2 (14 mg x 2 weeks)
Step 3 (7 mg x 2 weeks)
Generic
(formerly Habitrol)
10 cigarettes/day
Step 2 (14 mg x 6 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)
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
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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
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.
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Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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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Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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
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Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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
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:DIRECTIONS for USE (cont’d)
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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Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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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Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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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Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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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Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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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Copyright © 1999-2012 The Regents of the University of California. All rights reserved. Updated February 2012.
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