smoking cessation chapter tc · smoking cessation 165 class drug dose adverseeffects...

Psychiatric Disorders

Chapter 10Smoking CessationPeter Selby, MBBS, CCFP

Tobacco use kills approximately 48 000 Canadians annually, primarily fromcardiac disease, lung cancer and respiratory diseases such as COPD.1 Thetoxicity of cigarette smoke is due to the inhalation of about 4000 chemicalsincluding 50–60 carcinogens.2 Cigarettes are highly addictive because ofthe rapid delivery of nicotine to the mesolimbic reward pathways in thebrain and development of tolerance. The short half-life of nicotine (60–90minutes) forces repeated administration to maintain nicotine levels.3 Otherpsychoactive compounds in smoke include MAO-A and MAO-B inhibitors.4The polyaromatic hydrocarbons (PAHs) are inducers of CYP1A1, 1A2 and2E1 enzymes that have clinical implications when smokers quit.5

Goals of Therapy6■ The ultimate goal is to help smokers achieve complete and sustained

remission from tobacco use and nicotine dependence■ An intermediate goal is to help them achieve complete and sustained

remission from cigarette smoking and/or other forms of tobacco productssuch as chewing tobacco

■ To help smokers understand that:– smoking cessation is a process not a singular event; helping smokers

stay engaged in the process of behaviour change is a major objective oftherapy

– the best odds of quitting are achieved when behavioural andpharmacologic interventions are used to complement each other

– reduction in smoking by 50% in those unable or unwilling to quit iscontroversial because there is no long-term health benefit.7 However,reduction is associated with subsequent successful quitting8

Investigations■ Figure 1 provides a general assessment questionnaire■ Measures of physical dependence include the Fagerström Test of Nicotine

Dependence.9 A shorter version is the Heaviness of Smoking Index, whichassesses the level of tobacco dependence based on questions such as:“How early in the day do you smoke your first cigarette?” and “How manycigarettes do you smoke per day?”10 The earlier a person smokes the firstcigarette of the day and the more cigarettes smoked per day, the higher thelevel of dependence.

Therapeutic Choices. Copyright © 2011 Canadian Pharmacists Association. All rights reserved.

154 Psychiatric Disorders

Figure 1: Tobacco-smoking History Questionnaire


Chapter 10: Smoking Cessation 155■ Motivation can be assessed along a continuum by asking the following

2 questions:– “Given everything going on in your life right now, on a scale of 1 to 10,

where 10 is the most important thing to do right now, how important is itfor you to quit smoking altogether?”

– “Given everything going on in your life right now, on a scale of 1 to10, where 10 is the most confident you have felt about anything, howconfident do you feel you will be able to quit smoking altogether?”

Therapeutic ChoicesThis chapter will focus on smokers who want to quit in the next 30 days.Figure 2 provides an algorithm for smoking cessation strategies based onreadiness to quit and level of nicotine dependence.

Nonpharmacologic ChoicesMost smokers try to quit on several occasions and success rates for individualattempts are generally low. Many methods for quitting smoking have beenadvocated; however, few have been demonstrated to be effective. This typeof evidence generally requires randomized controlled trials with a minimumfollow-up assessment of self-reported quit rates at 6 months along withsupportive objective evidence, e.g., measurement of exhaled carbon monoxideor cotinine levels in urine, saliva or serum.6 Though widely promoted, there isno evidence for the efficacy of hypnosis or acupuncture.

The 5 evidence-based steps required to successfully quit include thefollowing:6■ setting a target quit date■ getting professional help■ enlisting social support■ using medication to quit smoking■ using problem-solving methods of counselling to quit and remain smoke

free.

There is a dose-response relationship between counselling and quit success.6Estimated abstinence rates increase from 13.4% with minimal counsellingcontact time (<3 minutes) to an average of 22% with contact time >10minutes. Optimal total contact time is 91–300 minutes, yielding abstinencerates of approximately 28%.6 Smokers who are attempting to quit should becounselled at least once prior to their quit date, the week following their quitdate and weekly thereafter as necessary to optimize therapy and to identify andmanage early relapse.6 Formats that have been shown to be effective includeface-to-face (individual or group) counselling as well as contact by telephone,mail and Internet, e.g., www.smokershelpline.ca, www.stopsmokingcentre.netand www.pregnets.ca for pregnant smokers.



Figure 2: Management of Smoking Cessation


Chapter 10: Smoking Cessation 157Pharmacologic ChoicesThe addition of pharmacotherapy increases the odds of quitting (see Table 1)and should be offered to all patients who smoke more than 10 cigarettes perday and wish to quit. Exceptions are those with a known contraindication todrug therapy or populations less likely to benefit from pharmacotherapy suchas adolescents in whom pharmacotherapy has not been shown to provideadditional benefit over behavioural approaches.6 Pharmacotherapy can bedivided into first-line and second-line medications.6 First-line medicationsinclude all forms of nicotine replacement therapy, bupropion andvarenicline (an alpha4beta2-nicotinic receptor partial agonist with quit rateshigher than previously existing therapies, at 2 mg/day; see Table 1).11,12,13 Dueto reports of neuropsychiatric side effects, the varenicline product monographincludes a boxed warning advocating caution and close monitoring in allpatients for the development of changes in mood or thoughts of harm toself or others. For patients with a history of past or current psychiatricillness, varenicline should be used with extreme caution, and diligentmonitoring by a health professional is recommended to monitor for new orworsening symptoms. Agitation-type reactions have also been reported withantidepressants including bupropion, and monitoring is recommended formood or behavioural changes or thoughts of harm to self or others in patientstaking bupropion for smoking cessation.

Second-line pharmacotherapies have evidence of efficacy but are notofficially indicated for smoking cessation. These include nortriptyline andclonidine.14,15,16,17 Nortriptyline can be used in otherwise healthy individualswith minimal risk for overdose or cardiac disease when first-line therapiesare either unaffordable or have not worked. Clonidine may be used inthose with coexisting hypertension, where appropriate. However, posturalhypotension can be problematic and the drug must be tapered to preventrebound hypertension.

Table 1: Estimated 6-Month Abstinence Rates6,18

Intervention Estimated Abstinence Rate at 6 Monthsa,b,c

Nicotine gum 19%

Nicotine patch 23.7%

Nicotine inhaler 24.8%

Nicotine lozenge 19.9%

Bupropion 24.2%

Bupropion plus nicotine patch 28.9%

Nicotine patch plus as-needed inhaler, gum orlozenge

29.7%(average)

Varenicline 1 mg BID 33.2%

Varenicline 0.5 mg BID 25.4%a Average quit rates following usual course of therapy.b Longer duration of therapy may result in slightly higher abstinence rates.c Abstinence rates for placebo average around 13%.



Choice of medication should depend on patient preference and absence ofcontraindications (such as recent myocardial infarction or stroke for nicotinereplacement therapy). Monotherapy is the norm. Combination therapy suchas the nicotine patch combined with either as-needed nicotine dosage forms(gum, inhaler or lozenge) or bupropion is associated with higher 6-monthabstinence rates than monotherapy.6,18 However, cost may be a limiting factorand combination therapy should be reserved for those in whom quittingimmediately is essential. Varenicline has not been studied in combinationwith other medications and is contraindicated in combination with nicotinereplacement therapy. Nicotine nasal spray and sublingual tablets are notavailable in Canada.

Choices during Pregnancy and BreastfeedingSmoking and Pregnancy

Smoking before, during and after pregnancy is associated with negativeoutcomes for both mother and baby.19,20,21,22,23,24 Nicotine readily crosses theplacenta and is concentrated on the fetal side. Moreover, carbon monoxide andother teratogens and carcinogens in cigarette smoke also cross the placenta.Adverse effects such as intrauterine growth retardation, increased risk ofsudden infant death syndrome (SIDS) and potential behavioural and metaboliceffects manifesting in childhood make tobacco smoke one of the mostdamaging teratogens, with permanent and significant morbidity and mortality.Smoking is also associated with a reduction in the amount of breast milk.

Most women who smoke will attempt to quit when they discover theyare pregnant, but the majority will ultimately continue to smoke. Factorsassociated with successful quit attempts include: first pregnancy; firsttrimester; low level of tobacco dependence; sharing a household withnonsmokers; higher education; not suffering from depression. The relapserate postpartum is about 60% at 6 months, and reflects the chronic relapsingnature of tobacco addiction.

Pregnancy is seen as a “teachable moment” in terms of smoking cessation.Quitting at anytime during pregnancy is associated with improved birthoutcomes. Routine screening for tobacco use is recommended for all pregnantwomen, as well as interventions to help smokers quit. There are no knownrisks to stopping “cold turkey” while pregnant, and quitting should not bedelayed until the postpartum period because the motivation to stop smokingdiminishes once the pregnancy is completed. There is reluctance to usepharmacotherapy in pregnancy due to the known and unknown adverseeffects of available treatment. The risk/benefit equation for smoking cessationpharmacotherapy in pregnancy depends on whether there is additional benefitover behavioural measures. With NRT it is unlikely there is any additionalrisk incurred from using the lowest effective dose of nicotine, considering itwill be delivered via less dangerous routes. Any potential harm from usingNRT must be weighed against that caused by continued smoking.

Management Prior to Conception

Reduction in smoking prevalence in women of childbearing age canpotentially improve maternal and fetal health.25 Whenever feasible, both


Chapter 10: Smoking Cessation 159potential parents should be given assistance to quit smoking, as women whosepartners smoke are less likely to quit.

Sperm cells are rendered abnormal (altered morphology, number and motility)by tobacco smoke.25 DNA-adducts and benzopyrene (a carcinogen fromtobacco smoke) are incorporated into the gamete, with the major contributionfrom sperm. Men should quit smoking for at least 3 months prior to attemptedconception, to allow sufficient time for replacement of the abnormal sperm.Since smoking is a major reversible cause of infertility, all couples shouldbe given assistance to quit smoking prior to undergoing fertility treatment.Smoking cessation pharmacotherapy can be used during this period withoutconcern for teratogenic effects.

Management during Pregnancy and Postpartum Period

Screen all pregnant women for smoking status and exposure to second-handsmoke at the first appointment and periodically during the pregnancy. Allshould be advised and assisted to completely stop smoking completely as soonas possible.26,27 Behavioural treatment, either in person (individual/group)or telephone-based, is recommended. Avoid pharmacotherapy unless thewoman is unable to quit using behavioural measures alone. There is nogood evidence for the efficacy or safety of NRT, bupropion or varenicline inpregnancy.28,29, One underpowered RCT of the nicotine patch in pregnancyfound no difference in quit rates compared to placebo, but a trend to increasedbirth weight in the offspring.30

Given the teratogenic nature of tobacco, the practitioner and the pregnantpatient face a dilemma when she is unable to quit smoking. When possible,such women should be referred to an expert in smoking cessation in pregnancy,and a teratology information centre such as Motherisk should be consulted.Offer the lowest effective dose of short-acting nicotine (gum), to eliminateexposure to smoke and minimize the amount of nicotine exposure to thefetus.31 This may be continued for 8–12 weeks with the goal of maintainingabstinence. There is no agreement on the maximum number of pieces perday. Reserve the transdermal patch for heavily dependent smokers and thosewho do not respond to the gum, and recommend removal after 16 hours, e.g.,at bedtime, to reduce fetal nicotine exposure.6,32 Bupropion may be used,especially in those women with an additional diagnosis of depression, as longas there are no contraindications. Use of bupropion during pregnancy has notbeen associated with a higher risk of congenital malformations.33 Vareniclinehas not been studied in human pregnancy.

Smoking and Breastfeeding

Smoking reduces the production and quality of breast milk.34 However,the amount of nicotine exposure is minimal and overall the benefits ofbreastfeeding outweigh the risks of continued smoking. NRT and bupropionmay be used if the benefits outweigh the potential risks. There are nopublished data on the safety of varenicline or its transmission to breast milk.

Continued breastfeeding is associated with delayed relapse in women whohave quit smoking.35 If women smoke and also breastfeed, educate them aboutthe risks to the baby from second-hand smoke, and advise them to smoke



outdoors and not to smoke just before or during breastfeeding. Changingclothes and hand-washing also reduce the “off-gassing” of toxins aftersmoking a cigarette.

Therapeutic Tips■ Encourage smokers who have slips while on medication to continue

medication for at least 4 weeks and use behavioural interventions to helpthem to stop smoking.36

■ If smokers using the patch complain of unmanageable cravings andsmoke cigarettes, add nicotine gum, lozenge or inhaler as a breakthroughmedication.6

■ It is important to monitor for low mood and emergence of depression insmokers who quit, regardless of the method used to quit.37

■ Address potential weight gain following smoking cessation before quitting,and offer practical advice to help smokers avoid gaining weight (healthydiet and exercise, avoidance of high-sugar products which patients cravewhen they quit smoking).38,39

■ Create a therapeutic relationship in which the patient can report back at thefirst signs of a relapse to abort it as soon as possible.

■ Be aware of the effect of smoking on hepatic metabolism. Induction ofCYP1A2 by cigarette smoking can increase the clearance and potentiallynecessitate higher doses of drugs such as caffeine, clozapine, diazepam,estrogens, fluvoxamine, methadone, nifedipine, olanzapine, rasagiline,theophylline, trifluoperazine or warfarin. Conversely a reduction of thedose may be required if the patient quits smoking. Patients should be madeaware of the potentially increased effects (and side effects) of caffeinewhen they quit smoking.

■ For adolescents, school-based programs that provide complex interventionswith elements of cognitive behavioural therapy (CBT) matched to stages ofchange show promise.40,41


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Table 2: Pharmacologic Agents Used for Smoking Cessation

Class Drug Dose Adverse Effects Drug Interactionsa Comments Costb

NicotineReplacement,immediate-release

nicotine inhalerNicorette Inhaler

First 6–12 wk: 1 cartridge, asneededEncourage patient to use atleast 6 cartridges/day for the first3–6 wkMaximum 12/dayTapering: gradual reduction inuse over next 6–12 wk, stoppingwhen reduced to 1–2/day

Mild local irritation(cough, throat irritation,stomatitis, rhinitis)that may declinewith continued use;headache, nausea,dyspepsia.

No known significant druginteractions.

Not a true inhaler—eachcartridge lasts for about 20min of puffing and delivers4 mg of nicotine, of whichapproximately 2 mg isabsorbed buccally.“Hand-mouth” activityfrom using the inhaler ispreferred by some quitterswhile others find it to bea trigger. Useful in thosewith poor oral health ordentures and in those whocannot chew gum. Coldtemperatures can decreasethe absorption rate. Ifspending time in coldenvironments, store inhalerin a warm place such as aninner clothing pocket.

$$

nicotine bitartratedihydratelozengeThrive

Initial strength: 1 mg if <20cigarettes per day, 2 mg if ≥20cigarettes per dayDosing frequency: see nicotinepolacrilex lozenges; maximum15/day for 2 mg strength, 25/dayfor 1 mg strength

Hiccoughs, GIdisturbances, jawpain and orodentalproblems.

Avoid use of acidic beveragesand foods (coffee, fruit juices,soft drinks, alcohol) whilechewing and 15 min before(decreases absorption).

Lozenges should beallowed to slowly dissolveand moved from one sideof the mouth to the otherperiodically.

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(cont’d)

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162Psychiatric

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Table 2: Pharmacologic Agents Used for Smoking Cessation (cont’d)


nicotinepolacrilexlozengeNicoretteLozenge

Nicotine: Use initial strength of2 mg if first cigarette of the day>30 min after waking, 4 mg if≤30 minWeeks 1–6: 1 lozenge Q1–2HPRN (maximum 15/day)Weeks 7–9: 1 lozenge Q2–4HPRNWeeks 10–12: 1 lozenge Q4–8HPRNDiscontinue when dose has beenreduced to 1–2 lozenges/dayUse beyond 6 mo generally notrecommended

See nicotine bitartratedihydrate lozenge.



$$

nicotinepolacrilex gumNicorette Gum,Thrive

Stopping abruptly: 10–12pieces/day (initial dose of 2 mgfor lighter smokers, 4 mg forheavier smokers—consultindividual product insert)Maximum 20 pieces/day, forup to 6 moStopping gradually in thosenot ready to quit: use lowesteffective dose of gum to relieveacute cravings, to prolonginterval between cigarettes.Goal is to reduce smoking by50% within 4 mo, and quit within6 mo. Maximum 20 pieces/day,for no more than 12 moTapering: 1 piece/day each wk,as withdrawal symptoms allow.



Instruct patient to bite downonce or twice then parkgum between the teeth andgums for about 1 min. Use4 mg in heavily dependentsmokers. May be used fortemporary abstinence, e.g.,to comply with smokingrestrictions on airplanes.

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Chapter

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163Class Drug Dose Adverse Effects Drug Interactionsa Comments Costb

NicotineReplacement,sustained-release

nicotinetransdermalpatchHabitrol,Nicoderm,Nicorette Patch,generics

Habitrol:>20 cigarettes/day: 1 patch(21 mg/24 h) daily × 3–4 wk≤20 cigarettes/day: 1 patch(14 mg/24 h) daily × 3–4 wkTapering: reduce strength ofpatch (i.e., from 21 to 14 to7 mg/24 h) every 3–4 wkNicoderm:21 mg/24 h × 6 wk then14 mg/24 h × 2 wk then7 mg/24 h × 2 wkIf patient has cardiovasculardisease, weighs less than 45 kgor smokes <½ pack/day beginwith 14 mg/24 h × 6 wk then ↓ to7 mg/24 h × 2 wkNicorette: 15 mg patch daily x6 wk. If desired, ↓ to 10 mg dailyx 2 wk then 5 mg daily x 2 wkbefore discontinuing. Maximum10 wk.

Skin sensitivityand irritation (mostcommon); abnormaldreams; insomnia;nausea, dyspepsia.

No known significant druginteractions.

Start patch on the quitdate. Advise not to smokecigarettes while usingthe patch, though this isgenerally safe and does notindicate treatment failure.Educate users on the signsand symptoms of nicotinetoxicity.Habitrol: Takes longerto reach peak levels thanNicoderm; should not usewhile exercising; majorsupplier of the generic/storebrands.Nicoderm: More rapidonset and shorter time topeak effects; may be wornwhile exercising; althoughnot recommended by themanufacturer, can be cutwithout damaging thedelivery device.Nicorette: Better dosingflexibility and outcomes withgum/patch combinationtherapy.

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(cont’d)


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164Psychiatric

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Table 2: Pharmacologic Agents Used for Smoking Cessation (cont’d)


NicotineReceptor PartialAgonists

vareniclineChampix

0.5 mg daily po for 3 daysthen BID for 4 days then 0.5–1mg BID po for 12 wk. Patientshould quit smoking 1–2 wk afterstarting varenicline. If patient isstill smoking 4 wk after starting,reassess therapy; can becontinued for an additional 12 wkif patient has benefited. If 1 mgBID not tolerated, can reduceto 0.5 mg BID. No taperingnecessary when discontinuing

Nausea (30%); may bemitigated by taking on afull stomach, increasingwater intake or reducingdose.May cause insomnia;take second daily doseat suppertime.Neuropsychiatricside effects such assuicidal/homicidalideation have beenreported; monitorclosely for changesin mood/behaviour.Close monitoring byhealth professional forthose with preexistingpsychiatric disorders.

Should not be combinedwith nicotine replacementtherapy due to increased riskof adverse effects.

Does not inducecytochrome P450enzymes; excreted renallyunchanged. Efficacy isdose related.

$$$$$

Antidepressants bupropionZyban, generics

150 mg daily po × 3 days then150 mg BID po × 7–12 wk. Begin1–2 wk before the selected quitdate

Usual: insomnia, drymouth, dizziness,restlessness, difficultyconcentrating.Unusual:hypersensitivityreactions, ↑ risk ofseizures at higherdosages; agitation-typereactions involvingmood/behaviouralchanges.

Inhibits CYP2D6; may ↓clearance of atomoxetine,duloxetine, fluoxetine,fluvoxamine, paroxetine,risperidone, sertraline,venlafaxine; may ↓effectiveness of codeineand tamoxifen. Do notuse with MAO inhibitors(possible mania, excitation,hyperpyrexia). May be safelycombined with NRT (monitorfor treatment-emergenthypertension).

Not recommended inpatients with conditionspredisposing to seizures,history of seizures, currenteating disorder or severehepatic impairment.Least expensive of oralmedications officiallyindicated for smokingcessation.

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Chapter

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Cessation

165Class Drug Dose Adverse Effects Drug Interactionsa Comments Costb

nortriptylinegenerics

25 mg/day po titrated to 75–100mg/day po. Quit day is usuallyset between 1 and 4 wk;medication is continued for12 wk

Common: drymouth, blurred vision,constipation, dizziness,sedation. Lesscommon: confusion,arrhythmias, urinaryretention.

Do not use with MAOinhibitors (may cause mania,excitation, hyperpyrexia).Inducers of CYP2D6or CYP3A4 such ascarbamazepine, phenytoinor rifampin may ↓ effect.Inhibitors of CYP2D6or CYP3A4 such asclarithromycin, erythromycin,grapefruit juice, fluoxetine orparoxetine may ↑ effect andtoxicity.

Caution in patients withcardiovascular diseaseor arrhythmias. Considermeasuring serum levelsto reach therapeutic dose(based on efficacy data fordepression).

$$

Alpha2-adrenergicReceptorAgonists

clonidineCatapres,generics

0.1 mg BID po starting up to 3days before or on the quit date.Increase by 0.1 mg/day po onceper wk if needed. Duration oftherapy ranges from 3–10 wk

Common: sedation,dizziness, hypotension,dry mouth.Less common: anxiety,irritability, memoryproblems.

Avoid concurrent use withtricyclic antidepressants.Additive effects with otherCNS depressants such asethanol. Additive hypotensiveeffect when combined withantihypertensive drugs.

Monitor blood pressure andheart rate during treatmentinitiation. Taper gradually toavoid rebound hypertensionwhen stopping treatment.

$

a Cigarette smoking can increase the clearance of many drugs through mechanisms such as induction of cytochrome P450 enzymes CYP1A1, 1A2 or 2E1. Patients taking drugs such as caffeine, clozapine,diazepam, estrogens, fluvoxamine, methadone, nifedipine, olanzapine, rasagiline, theophylline, trifluoperazine or warfarin may require dosage reduction when they quit smoking.

b Cost of 100 pieces of gum or lozenges, 42 cartridges, 28 patches or 30-day supply of tablets; includes drug cost only.Dosage adjustment may be required in renal impairment; see Appendix I.

Abbreviations: CVS = cardiovascular; NRT = nicotine replacement therapyLegend: $ < $25 $$ $25–50 $$$ $50–75 $$$$ $75–100 $$$$$ $100–125


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