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Copyright © 1999-2015 The Regents of the University of California. All rights reserved. Updated December 2014.
Rx for CHANGEClinician-Assisted Tobacco Cessation
August 2021CSAM Review Course & Exam
Preparation Track
Smita Das, MD, PhD, MPHClinical Associate Professor, Stanford University School of Medicine, Stanford, CA
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Conflict of Interest Disclosure
I have nothing to relevant disclose, and I will not be discussing “off label” use of drugs or devices in this
presentation.
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Objectives
Explain the relevance and importance of tobacco cessation treatment in addiction settings.
1Review smoking+mental illness epidemiology, medication interactions, nicotine, dual diagnosis and withdrawalsymptoms.
2Provide brief skills for clinicians using behavioral techniques for smoking cessation, including the 5 A's and pharmacologic cessation aids in psychiatry.
3Be able to access RxforChange, a web based curriculum to disseminate tobacco treatment training for health care professionals, including specific training for psychiatric settings.
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For even more slides, handouts and resources (free of charge), visit RxForChange.ucsf.edu
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EPIDEMIOLOGY of TOBACCO USE
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Copyright © 1999-2015 The Regents of the University of California. All rights reserved. Updated December 2014.
FACTORS CONTRIBUTING toTOBACCO USE
Individualn Sociodemographicsn Genetic predispositionn Coexisting medical
conditions
Environmentn Tobacco advertisingn Conditioned stimulin Social interactions
Pharmacologyn Alleviation of withdrawal
symptomsn Weight controln Pleasure, mood modulationTobacco
Use
Focus in on psychiatric populations…
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Smoking, Substance Use Disorders (SUD) and Mental Illness
n 20% of the population uses a tobacco productn Cigarettes (13.7%), cigars (3.9%), e-cigarettes (3.2%)
n Individuals with mental illness and/or SUD n 2-4 fold higher rates of smokingn Consume 44-46% of cigarettes sold in the USn Account for 200,000 of the 480,000 premature deaths annually n Die on average 25 years earlier (treatable conditions related to
tobacco use)n Smoking accounts for more morbidity than alcohol and all
other drugs combined, even among individuals with SUD
https://www.cdc.gov/mmwr/volumes/68/wr/mm6845a2.htm Grant, et al, Arch Gen Psych, 2004 Colton, Manderscheid, Prev Chronic Disease 2006Lasser, et al, JAMA, 2000 Schroeder, Morris, Ann Review Pub Health, 2010Surgeon General’s Report, 2014
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Social: ENABLING ENVIRONMENTS
Pub. 1951
1951
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SELF-MEDICATION BELIEFS
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Copyright © 1999-2015 The Regents of the University of California. All rights reserved. Updated December 2014.
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Department of Health, Education, and Welfare National Institute of Mental Health
Washington, DC August 4, 1980
I am writing to request a donation of cigarettes for long-term psychiatric patients…because of recent changes in the DHHS regulations, Saint Elizabeth Hospital can no longer purchase cigarettes for them.
I am therefore requesting a donation of approximately 5,000 cigarettes a week (8 per day for each of the 100 patients without funds).
Slide from Judith J. Prochaska, PhD, MPH
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LD 463 - An Act to Exempt Substance Abuse and Psychiatric Patients from the Prohibition against Smoking in Hospitals
Slide from Judith J. Prochaska, PhD, MPH
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ANNUAL U.S. DEATHS ATTRIBUTABLE to SMOKING, 2005–2009
33%27%23%
9%7%
<1%
Cardiovascular & metabolic diseases 160,600Lung cancer 130,659Pulmonary diseases 113,100Second-hand smoke 41,280Cancers other than lung 36,000Other 1,633
Percent of all smoking-attributable deaths
TOTAL: >480,000 deaths annuallyU.S. Department of Health and Human Services (USDHHS). (2014).
The Health Consequences of Smoking—50 Years of Progress: A Report of the Surgeon General.
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Copyright © 1999-2015 The Regents of the University of California. All rights reserved. Updated December 2014.
QUITTING: HEALTH BENEFITS
Lung cilia regain normal functionAbility to clear lungs of mucus increasesCoughing, 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 smokerRisk 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 months1 to 9
months
1year
5years
10years
after15 years
Time Since Quit DateCirculation improves,
walking becomes easierLung function increases
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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
FEV1
(% o
f val
ue a
t age
25)
Forc
ed E
xpira
tory
Vol
ume
25
50
75
100
050 75
Age (years)
COPD = chronic obstructive pulmonary disease
AT ANY AGE, there are benefits of quitting.
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EPIDEMIOLOGY of TOBACCO USE: SUMMARY
n Nearly one in five adults are current smokers; smoking prevalence varies by sociodemographic characteristics.
n Nearly half a million U.S. deaths are attributable to smoking annually.
n Smoking costs the U.S. an estimated $288.9 billion annually.
n For the individual, a smoking a pack-a-day costs $2,256 annually, plus associated health-care costs.
n At any age, there are benefits to quitting smoking.
n The biggest opponent to tobacco control efforts is the tobacco industry.
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FORMS of TOBACCO
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Copyright © 1999-2015 The Regents of the University of California. All rights reserved. Updated December 2014.
FORMS of TOBACCO n Cigarettesn Smokeless tobacco (chewing tobacco, oral snuff)n Pipesn Cigarsn Clove cigarettesn Bidisn Hookah (waterpipe smoking)n Electronic cigarettes (“e-cigarettes”)…
Image courtesy of the Centers for Disease Control and Prevention / Rick Ward
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n Generally similar in appearance to cigarettes, cigars, pipes, or pens
n Battery-operated devices that create a vapor for inhalationn Simulates smoking but does not involve
combustion of tobaccon Also known as
n E-cigaretten E-hookah, Hookah pen n Vapes, Vape pen, Vape pipen Electronic nicotine delivery system (ENDS)
ELECTRONIC CIGARETTES
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n Power source: Rechargeable/disposable battery
n Cartridge containing liquid solutionn Propylene glycoln Glycerinn Flavorings (tobacco, fruit, chocolate, mint, cola, candy, etc.)n Nicotine (0-36 mg/mL); Nicotine yield varies based on the
experience level of the usern Testing 32 cartridges, 9 showed differences between
labelled and detected nicotine concentrations larger than 20%; trace nicotine in three products labelled as nicotine-free (Goniewicz et al: NTR, 2013 and International Journal of Drug Policy, 2015)
n Electronic atomizer/vaporizern Heating element vaporizes liquid at temperatures 65-120 °C
ELECTRONIC CIGARETTES: Components
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n Propylene glycol may cause respiratory irritation and increase the risk for asthma
n Glycerin may cause lipoid pneumonia on inhalationn Nicotine is highly addictive and can be harmful
n Refill cartridges with high concentrations of nicotine are a poisoning risk, especially in children
n Carcinogenic substances are found in some aerosolsn Use of e-cigarettes leads to emission of propylene glycol,
particles, nicotine, and carcinogens into indoor airn Long-term safety of second hand exposure to e-cigarette aerosols is
unknown
Electronic cigarettes are not proven to be safe.
ELECTRONIC CIGARETTES: Potential health risks
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Copyright © 1999-2015 The Regents of the University of California. All rights reserved. Updated December 2014.
E-cigarettes: Youthn LA HS student study: Ever users compared with nonusers more likely
initiate combustible tobacco use over next year n 1/5 e-cigarette using adolescents use device to smoke cannabis oiln "Nicotine acts as a gateway drug on the brain, and this effect is likely to
occur whether the exposure is from smoking tobacco, passive tobacco smoke, or e-cigarettes" and concern that behavior is outpacing science (Kandel and Kandel NEJM 2014)
Morean et al., 2015 Pediatrics Rigotti, Jama 2015
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Use routinely for cessation? Not based on current evidencen One Cochrane review investigating e-
cigarette for cessationn Combined, 2 studies suggest e-cigarette vs placebo
does have an effect on cessation BUT low gradeevidence (“Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate”)
n No difference in e-cigarette versus NRTn 2019 study in NEJM: 886 smokers randomized to e-
cigs or NRT; 1 year abstinence was 18.0% in e-cig compared to 9.9% NRT.
Bullen et al, Lancet 2013; Caponnetto et la, Plos One 2013; McRobbie, Cochrane Database 2015; Hajek P, et al. N Engl J Med. 2019
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National Academies of Sciences, Engineering, and Medicine : Public Health Consequences of E-Cigarettes
There is conclusive evidence that:n E-cigarette use increases airborne concentrations of particulate matter and
nicotinen Exposure to nicotine from e-cigarettes is highly variablen Most e-cigarette products contain and emit numerous potentially toxic
substances… other than nicotine, the number, quantity, and characteristics of potentially toxic substances emitted from e-cigarettes are highly variable
n E-cigarette devices can explode and cause burns and projectile injuries. Such risk is significantly increased when batteries are of poor quality, stored improperly, or modified by users.
n Intentional or accidental exposure to e-liquids…can result in adverse health effects including…seizures, anoxic brain injury, vomiting, and lactic acidosis.
n Intentionally or unintentionally drinking or injecting e-liquids can be fatal. n Completely substituting e-cigarettes for combustible tobacco cigarettes reduces users’
exposure to toxicants and carcinogens present in combustible tobacco cigarettes.
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Recommendationsn Newly regulated: FDA proposed to subject e-cigarettes to
regulatory oversight like other tobacco productsn FDA safety reports by consumers and health care professionals
have reported pneumonia, congestive heart failure, seizures, and hypertension in connection with use of these products
n >20 countries have banned e-cigarettesn AHA Summary Statement:
n Clinicians should not recommend e-cigarettes as primary cessation aidsn Also if patient has tried evidence based methods, it “is reasonable to
support the attempt.”n If a smoker is using e-cigarettes, consider quit date
n While harm reduction is still being researched, concern about youth, new users is very concerning
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Copyright © 1999-2015 The Regents of the University of California. All rights reserved. Updated December 2014.
FORMS of TOBACCO: SUMMARY
n Cigarettes are, by far, the most common form of tobacco used in the U.S.
n Other forms of tobacco and nicotine delivery devices exist, and some are increasing in popularity.
n All forms of tobacco are harmful.
n The safety/efficacy of e-cigarettes is not established.
n Attention to all forms of tobacco is needed.
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NICOTINE PHARMACOLOGY and PRINCIPLES of ADDICTION
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NICOTINE DISTRIBUTION/METABOLISM
Henningfield et al. (1993). Drug Alcohol Depend 33:23–29.
01020304050607080
0 1 2 3 4 5 6 7 8 9 10Minutes after light-up of cigarette
Plas
ma
nico
tine
(ng/
ml) Arterial
Venous
Nicotine reaches the brain within 10–20 seconds.
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NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
â Dopamine
â Norepinephrine
â Acetylcholine
â Glutamate
â Serotonin
â b-Endorphin
â GABA
NI
C
OT
IN
E
â Pleasure, appetite suppression
â Arousal, appetite suppression
â Arousal, cognitive enhancement
â Learning, memory enhancement
â Mood modulation, appetite suppression
â Reduction of anxiety and tension
â Reduction of anxiety and tension
Benowitz. (2008). Clin Pharmacol Ther 83:531–541.
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Copyright © 1999-2015 The Regents of the University of California. All rights reserved. Updated December 2014.
n Irritability/frustration/angernAnxietynDifficulty concentratingnRestlessness/impatiencenDepressed mood/depressionn Insomnian Impaired performancen Increased appetite/weight gainnCravings
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.
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NICOTINE ADDICTION CYCLE
Reprinted with permission. Benowitz. (1992). Med Clin N Am 2:415–437.
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ASSESSINGNICOTINE DEPENDENCE
Fagerström Test for Nicotine Dependence (FTND)n Developed in 1978 (8 items); revised in 1991 (6 items)
n Most common research measure of nicotine dependence; sometimes used in clinical practice
n Responses coded such that higher scores indicate higher levels of dependence
n 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.
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PHARMACOKINETIC DRUG INTERACTIONS with SMOKING
Drugs that may have a decreased effect due to induction of CYP1A2:§ Bendamustine § Haloperidol § Tasimelteon§ Caffeine § Olanzapine § Theophylline§ Clozapine § Riociguat§ Erlotinib § Ropinirole§ Fluvoxamine § Tacrine§ Irinotecan (clearance increased and systemic exposure decreased,
due to increased glucuronidation of its active metabolite)n HANDOUT ON RxForChange website
Smoking cessation will reverse these effects.
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Copyright © 1999-2015 The Regents of the University of California. All rights reserved. Updated December 2014.
NICOTINE PHARMACOLOGY and ADDICTION: SUMMARY
n Tobacco products are effective delivery systems for the drug nicotine.
n Nicotine is a highly addictive drug that induces a constellation of pharmacologic effects, including activation of the dopamine reward pathway in the brain.
n Clinically significant interactions result the combustion products of tobacco smoke, not from nicotine. Drug interactions should be considered clinically.
n Tobacco use is complex, involving the interplay of a wide range of factors.
n Treatment of tobacco use and dependence requires a multifaceted treatment approach.
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ASSISTING PATIENTS with QUITTING
CLINICAL PRACTICE GUIDELINE for TREATING TOBACCO USE and DEPENDENCE
Sponsored by the U.S. Department of Health and Human Services, Public Heath Service with:
n Agency for Healthcare Research and Qualityn National Heart, Lung, & Blood Instituten National Institute on Drug Abusen Centers for Disease Control and Preventionn National Cancer Institute
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EFFECTS of CLINICIAN INTERVENTIONS
0
10
20
30
No clinician Self-helpmaterial
Nonphysicianclinician
Physicianclinician
Type of Clinician
Estim
ated
abs
tinen
ce a
t 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.
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Esti
mat
ed a
bsti
nenc
e ra
te
at 5
+ m
onth
s0
10
20
30
None One Two Three or more
Number of Clinician Types
1.0
1.82.5 2.4
n = 37 studies
The 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.
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Copyright © 1999-2015 The Regents of the University of California. All rights reserved. Updated December 2014.
IS a PATIENT READY to QUIT?Does the patient now use tobacco?
Is the patient now ready to quit?
Provide treatmentThe 5 A’s
Promote 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. Clinical Practice Guideline.Rockville, MD: USDHHS, PHS.
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The 5 R’s—Methods for enhancing motivation:
n Relevancen Risksn Rewardsn Roadblocksn Repetition
Tailored, motivational messages
STAGE 1: NOT READY to QUITCounseling Strategies
Fiore et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: USDHHS, PHS, May 2008.
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The 5 A’sASK about tobacco USE
ADVISE tobacco users to QUIT
ASSESS READINESS to make a quit attempt
ASSIST with the QUIT ATTEMPT
ARRANGE FOLLOW-UP care
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The 5 A’s (cont’d)
about tobacco usen “Do you ever smoke or use other types of tobacco or
nicotine, such as e-cigarettes?”
n “I take time to ask all of my patients about tobacco use—because it’s important.”
tobacco users to quit (clear, strong, personalized)
n “It’s important that you quit as soon as possible, and I can help you.”
ASK
ADVISE
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Copyright © 1999-2015 The Regents of the University of California. All rights reserved. Updated December 2014.
The 5 A’s (cont’d)
readiness to make a quit attemptASSESS
with the quit attemptn Not ready to quit: enhance motivation (the 5 R’s)n Ready to quit: design a treatment plann Recently quit: relapse prevention
ASSIST
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STAGE 2: READY to QUITAssess Tobacco Use History/Key Issues
n Assess tobacco use historyn Current use: type(s) of tobacco, brand, amountn Past use: duration, recent changesn Past quit attempts (when, aids used, reason for relapse)
n DSM Criterian Triggers, Stressn Weight
n On average, quitters gain 9 to 11 pounds, but there is a wide rangen Social Supportn Withdrawal: Most symptoms manifest within the first 1–2
days, peak within the first week, and subside within 2–4 weeks
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n Set a quit daten Coping Strategies: Cognitive and Behavioraln Provide medication counseling
n Promote compliance; Discuss proper use, with demonstration
n Discuss concept of “slip” versus relapsen Congratulate the patient! n Arrange Follow Up
Example: Follow-up contact #1: first week after quittingFollow-up contact #2: in the first monthAdditional follow-up contacts as needed
STAGE 2: READY to QUITFacilitate Quitting Process
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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.
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Copyright © 1999-2015 The Regents of the University of California. All rights reserved. Updated December 2014.
n Brief interventions have been shown to be effective
n In the absence of time or expertise:n 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.
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AIDS for CESSATION
Counseling and medications are both effective, but the combination of counseling and
medication is more effective than either alone.
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PHARMACOTHERAPY: 7 FDA Approved Treatments: NRT, Bupropion, Varenicline
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.”
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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
Plas
ma
nico
tine
(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 products approximately double quit rates.48
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Copyright © 1999-2015 The Regents of the University of California. All rights reserved. Updated December 2014.
TRANSDERMAL NICOTINE PATCH
DISADVANTAGESn Patients cannot titrate the
dose.n Allergic reactions to
adhesive may occur.
n Taking patch off to sleep may lead to morning nicotine cravings.
ADVANTAGESnThe patch provides consistent nicotine levels.
nThe patch is easy to use and conceal.
nFewer compliance issues are associated with the patch.
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TRANSDERMAL NICOTINE PATCH:DIRECTIONS for USE
n Choose an area of skin on the upper body or upper outer part of the arm
n Make sure skin is clean, dry, hairless, and not irritated
n Apply patch to different area each day
n Do not use same area again for at least 1 week
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NICOTINE GUM & LOZENGEDISADVANTAGESn Gastrointestinal side
effects may be bothersome
n Gum may be socially unacceptable and difficult to use with dentures
n Patients must use proper chewing technique to minimize adverse effects
ADVANTAGESn Patients can titrate
therapy to manage withdrawal symptoms
n May satisfy oral cravings
n May delay weight gain
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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
Do not eat or drink 15 min before or after use
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Copyright © 1999-2015 The Regents of the University of California. All rights reserved. Updated December 2014.
NICOTINE INHALERNicotrol Inhaler (Pfizer)
n Nicotine inhalation system consists of:n Mouthpiecen Cartridge with porous plug
containing 10 mg nicotine and 1 mg menthol
n Delivers 4 mg nicotine vapor, absorbed across buccal mucosa
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NICOTINE INHALER
DISADVANTAGESn Initial throat or mouth
irritation can be bothersome.
n Cartridges should not be stored in very warm conditions or used in very cold conditions.
n Patients with underlying bronchospastic disease must use the inhaler with caution.
ADVANTAGESnPatients can easily titrate therapy to manage withdrawal symptoms.
nThe inhaler mimics hand-to-mouth ritual of smoking.
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NICOTINE NASAL SPRAY
DISADVANTAGESn Nasal/throat irritation
may be bothersomen Dependence can resultn Patients must wait 5
min before driving or operating heavy machinery
ADVANTAGESn Most rapidly absorbed form of nicotine replacement
n Patients can easily titrate therapy to rapidly manage withdrawal symptoms
n Demonstrated use with smokers with schizophrenia
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BUPROPION SR:MECHANISM OF ACTION
n Atypical antidepressant, acts on dopamine and norepinephrinen Clinical effects
n ¯ craving for cigarettesn ¯ symptoms of nicotine withdrawal
Initial treatmentn 150 mg po q AM x 3 days
Then, if tolerated…n 150 mg po bid x 7–12 weeks
If 300 mg is not well tolerated…n Reduce dose to 150 mg and reassure that 150 mg dose is still
efficacious (Swan et al., 2003)
Patients should begin therapy one week PRIOR to quitting to assure therapeutic plasma levels of drug are achieved when patient is no longer smoking.
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Copyright © 1999-2015 The Regents of the University of California. All rights reserved. Updated December 2014.
BUPROPION SRDISADVANTAGESn Bupropion SR should be
avoided in patients with an increased risk for seizures
n Side effect profile:n Common: dry mouth, anxiety,
insomnia (avoid bedtime dosing)
n Less Common: tremor, skin rash
ADVANTAGESn Bupropion SR is easy to use.
n Bupropion SR can be used with NRT.
n Bupropion SR may be beneficial in patients with depression.
Effective for treating smoking regardless of depression history (Cox, 2004) and may decrease the negative symptoms in schizophrenia (George 2002, Evins 2005).
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VARENICLINE:MECHANISM of ACTION
n Binds with high affinity and selectivity at a4b2neuronal nicotinic acetylcholine receptorsn Stimulates low-level agonist activity
n Competitively inhibits binding of nicotine
n Clinical effectsn ¯ symptoms of nicotine withdrawal
n Blocks dopaminergic stimulation responsible for reinforcement & reward associated with smoking
Treatment Day Dose
Days 1–3 0.5 mg daily
Days 4–7 0.5 mg bid
Day 8 – Week 121 mg bid
Initial dose titration
Patients should begin therapy 1 week PRIOR to theirquit date. The dose is gradually increased to minimize treatment-related nausea and insomnia
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VARENICLINE: SUMMARYDISADVANTAGES
n Common side effects:n Nausea (in up to 33% of pts)n Sleep disturbances (insomnia,
abnormal dreams)n Constipationn Flatulencen Vomiting
n Black Box Warnings
ADVANTAGESn Varenicline is an oral
formulation with twice-a-day dosing.
n Varenicline offers a new mechanism of action for persons who previously failed using other medications.
n Strong efficacy data
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COMPARATIVE DAILY COSTS of PHARMACOTHERAPY
Cost per day, in U.S. dollars0 2 4 6 8
Clonidine
Nortriptyline
Patch
Bupr opion SR
Gum
Nasal spr ay
Chantix
Cigarettes (1 PPD)
Lozenge
Inh aler
$3.75 generic $5.00 in CA $5.88
$3.67$4.00
$3.48 (generic)$2.84 (generic)
$6.07
$1.13 (generic).91¢ (generic)
$2.62 (generic)
Varenicline
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Copyright © 1999-2015 The Regents of the University of California. All rights reserved. Updated December 2014.
LONG-TERM (³6 month) QUIT RATES for AVAILABLE CESSATION MEDICATIONS
0
5
10
15
20
25
30
Nicotine gum Nicotinepatch
Nicotinelozenge
Nicotinenasal spray
Nicotineinhaler
Bupropion Varenicline
Active drugPlacebo
Data adapted from Cahill et al. (2012). Cochrane Database Syst Rev; Stead et al. (2012). Cochrane Database Syst Rev; Hughes et al. (2014). Cochrane Database Syst Rev
Perc
ent q
uit
16.3 15.9
10.0 9.8
18.9
8.4
23.9
11.8
17.1
9.1
19.7
11.5 12.0
28.0
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COMBINATION PHARMACOTHERAPY
n Combination NRTLong-acting formulation (patch)
n Produces relatively constant levels of nicotine
PLUSShort-acting formulation (gum, inhaler, nasal spray)
n Allows for acute dose titration as needed for nicotine withdrawal symptoms
n Bupropion SR + Nicotine Patch
Regimens with enough evidence to be ‘recommended’ first-line
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A note on pregnant smokern 10-20% of women in US smoke when pregnantn NRT is class D and varenicline and bupropion are class Cn But smoking causes stillbirth, SIDS, placental abruption, preterm labor and is associated
with other pregnancy complicationsn Nicotine can affect fetus but smoking has more exposures than nicotine itselfn Psychosocial interventions are twice as effective as usual caren U.S. Preventive Services Task Force 2015 review summary:
n Not enough data to make recommendations about medications
n In a few studies, 2 year follow up found survival with no adverse outcomes of children higher for NRT versus placebo
n Preterm birth, C section and birthweight may be higher in some study NRT groupsn NRT may have a short-term effect on fetal breathing movements heart rate variability
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SUMMARYn To maximize success, interventions should include counseling
and one or more medicationsn Clinicians should encourage the use of effective medications by
all patients attempting to quit smokingn Exceptions include medical contraindications or use in specific
populations for which there is insufficient evidence of effectiveness
n First-line medications that reliably increase long-term smoking cessation rates include:n Bupropion SRn Nicotine replacement therapy (gum, lozenge, patch, nasal spray, inhaler)
n Varenicline
n Use of effective combinations of medications should be considered
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Copyright © 1999-2015 The Regents of the University of California. All rights reserved. Updated December 2014.
Clinical Implications
� Every encounter counts Rxforchange.ucsf.edu
� You are uniquely positioned to address the tobacco epidemic
� Reduce morbidity� Reduce mortality� Improve Quality of Life and other health outcomes
� Questions? Comments: [email protected]
Tobacco use disorders
Increased (worse outcomes among
those who SUD/homelessness)
Imperative to offer advice and help to
quit smoking+
Improve policies
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