Smoking Cessation

Sundeep Viswanathan and Amy McQueen

GENERAL PRINCIPLES

Epidemiology

• Cigarette smoking causes over 400,000 deaths annually in the United States. In 2012, 18.1% of adults smoked cigarettes.¹

• Rates of smoking vary based on ethnicity, region, socioeconomic status, and education. Smoking rates are also higher among people with disabilities, substance use problems, mental health disorders, and HIV/AIDS and people on Medicaid.

• Second- and third-hand smoke represent an underappreciated and definite risk to the household members of smokers and the general public.

Pathophysiology

• Nicotine stimulates acetylcholine receptors in the brain and activates the sympathetic nervous system, leading to elevated circulating levels of norepinephrine, epinephrine, vasopressin, growth hormone, cortisol, and endorphins. Nicotine also stimulates specific dopaminergic reward centers in the brain leading, to its psychological addiction. These result in increases in heart rate, blood pressure, cardiac stroke volume, and coronary blood flow.

• Other effects of nicotine use include arousal early in the day, relaxation during stressful situations, and an increased metabolic rate with reduced hunger leading to body weight reduction.

• Most smoking cessation attempts fail. Nicotine is addictive, and people become physiologically (and psychologically) dependent on its effects. People who quit experience withdrawal symptoms with the peak varying from 24 hours to 4 weeks after quitting. Withdrawal symptoms include anxiety, impatience, restlessness, irritability, hostility, difficulty in concentrating, nicotine cravings, headaches, insomnia, depression, dysphoria, and hunger. Patients with a previous history of major depression, bipolar disorder, or alcohol and drug abuse may be especially susceptible to withdrawal and relapse.

• Psychological addiction can continue for months to years following quitting. Daily activities related to smoking such as eating, drinking, sex, being around other smokers, and driving can act as triggers for nicotine cravings.

Associated Conditions

• There are multiple known carcinogens in cigarette smoke, resulting in a high risk of lung, oral, esophageal, laryngeal, and urothelial cancers.

• The risk of lung cancer increases in relation to the amount an individual smokes and the age at which he or she started smoking.

• Cigarette smoking alters immunity in the lung as well as the structure and function of the airways. Smokers have a lower forced expiratory volume over 1 second (FEV₁) and an accelerated rate of FEV₁ decline when compared with nonsmokers. Cigarette smoking has resulted in a high prevalence of chronic obstructive pulmonary disease (COPD). It is also an important trigger for asthma attacks.

• There is evidence that smoking contributes to vascular endothelial damage, coronary vasospasm, and increased platelet aggregation. Cigarette smoking is a known risk factor for coronary artery disease, hypertension, and stroke. Smoking also alters the senses of taste and smell.

• Smoking cessation mitigates some of these risks but does not drop the risk down to a lifelong nonsmoker.

DIAGNOSIS

• Studies have shown that physicians continue to do a poor job in identifying current smokers and urging them to quit despite the data behind the benefits of smoking cessation. Barriers include a lack of perceived training and awareness of resources on the part of physicians, low expectations that patients will actually quit, and low reimbursements for time spent discussing smoking cessation.

• Clinicians can use the Modified Fagerström Test for Nicotine Dependence to grade patients’ dependence.² Patients should be considered highly dependent on nicotine if they smoke >20 cigarettes per day, smoke their first cigarette of the day within 30 minutes of awakening, or if during a previous quit attempt they developed strong cravings or withdrawal symptoms. Because nicotine is an addictive substance, patients can be expected to cycle through multiple periods of relapse and remission. Physicians should support each quit attempt as they would for patients in alcohol or drug rehabilitation.

Diagnostic Criteria

• The following steps, initially developed by the National Cancer Institute as the “Four A’s” program, can be used in most outpatient settings to identify smokers and aid quitting. The Four A’s have been expanded to the Five A’s by the Clinical Practice Guidelines for Treating Tobacco Use and Dependence.³

• Ask: Systematically identify all tobacco users at every visit. Ask at every visit about smoking: Do you smoke? Have you considered quitting? Are you ready to quit? What can I do to help you quit? Consider expanding documentation of vital signs to include tobacco use.

• Advise: Strongly urge all tobacco users to quit at every visit. The goal is to present compelling evidence about the importance of quitting and to educate the patient about methods for quitting and the help available. Clear, strong, and personalized advice based on both the patient’s health and his or her social situation works best. For example, tie tobacco use to current illness or if the patient lives with children, the adverse effects of smoking on children.

• Assess: Determine willingness to make quit attempt by asking the patient to make a quit attempt at this time. If he or she is willing to try quitting, provide assistance and further information. Schedule a return visit to prepare a plan for smoking cessation. If the patient not ready to quit, continue to educate him or her about the risk of smoking and offer to schedule a follow-up visit to continue the discussion. However, even among smokers who report no plans to quit, pharmacotherapy use has been associated with increased quit attempts, fewer cigarettes smoked, and greater abstinence rates.⁴

• Assist: Aid the patient in quitting with the development of a quit plan. Give consideration to drawing up a contract for the patient to sign in a similar fashion to a narcotics contract or asthma management plan. Discuss the patient’s motivation for quitting and the benefits and drawbacks of quitting. Identify roadblocks to quitting, and discuss strategies for overcoming these. Encourage the patient to discuss the plan with family and friends and enlist their support. Suggest the patient remove all tobacco-related products from the house as the quit date approaches.

The smoker also may want to avoid alcohol because it is a cue for many patients to smoke.

Initiating an exercise plan should be encouraged, with the goal being twofold: (a) occupying the patient’s free time, leaving less time to smoke, and (b) helping avoid the weight gain associated with nicotine withdrawal. The average weight gain with smoking cessation is 2–3 kg, and it may be delayed by use of pharmacologic agents.

Provide pharmacologic therapy after assessment of the individual’s dependence and risk factors. Patients also benefit from counseling and/or scheduled follow-up. Most states have free telephone quit lines that patients can call for information and help with quitting. Encourage total abstinence as the ultimate goal, but acknowledge that even cutting down the number of cigarettes by 50% has some benefits and may improve later quit success. Similarly, nicotine replacement, even for long periods, is considered safer than smoking.

With patients who have had previous failed quit attempts, the discussion should center on the reasons for the failure and developing strategies to cope with these problems. Common reasons for failure include withdrawal, cravings, stress, illness, and situational factors.

• Arrange: Arrange follow-up visits to confirm and maintain abstinence. The physician, a counselor, or even office staff can perform the follow-up. Focus on positive health benefits of cessation and congratulate the patient on quitting. Assess and treat withdrawal symptoms as needed. Educate patients about the numerous resources available to them to help them stay quit. If patients relapse, offer encouragement, discuss reasons for failure, and offer continued support.

TREATMENT

• Achieving smoking cessation centers around a combination of counseling and behavior modification, strong social support, a knowledgeable and motivated patient, and pharmacologic therapies.

• Although the medication labels and inserts caution against using multiple nicotine products concurrently, research has shown that first-line agents can be used in combination safely and often with greater efficacy.⁵

• Results of the best single or combination of agents have varied across meta-analyses and trials.

• Common combinations include

Bupropion + patch OR

Patch + gum, lozenge, or nasal spray the following, which suggest a benefit of treating nicotine dependence through multiple mechanisms (i.e., steady delivery of patch + ad-lib use of faster-acting nicotine replacement therapies for acute cravings)

Medications

Several first-line therapies are available either by prescription or over-the-counter. Selecting the right first-line method should be made on an individual basis. The impact of comorbidities, contraindications, drug interactions, patient preference, ease and understanding of use, patient’s previous history of failed attempts, cost, and severity of addiction should all be taken into consideration.

• Nicotine replacement therapy (NRT)

NRT works via direct absorption into the circulation through the buccal mucosa, nasal mucosa, or skin. NRT should be considered for any smoker attempting cessation, but it is contraindicated in anyone with unstable angina or within 2 weeks of a coronary event. There is however no increased cardiovascular risk in patients with known cardiovascular disease.

It has not been approved for use during pregnancy, but because circulatory levels are lower than those achieved by actual cigarette smoking, NRT should in theory cause less uterine vasoconstriction, and therefore be safer, than smoking.

NRT may be used in a step-down method, but doing so may prolong the total duration of therapy. There is a low potential for dependence because blood nicotine levels achieved with any method of NRT are lower than levels achieved through cigarette smoking. NRT also does not produce tar and carbon monoxide, which are other substances linked to the ill effects of smoking.

Underuse (not overuse) of NRT is a substantial problem which hinders quit success, and some research shows that smokers are more concerned about nicotine addiction than the harms from smoking, so healthcare professionals should inform patients of the relative harms.

The recommended course of treatment varies by NRT product, but research has shown that some people (especially heavy smokers) may benefit from longer periods and combinations of NRT until they are confident they will not relapse.

In general, it is advised that patients start NRT on their quit date and not smoke while on NRT. However, some studies have shown positive effects of starting the patch a week before the quit date. Patients using NRT should be encouraged not to give up if they relapse and have a cigarette. In these cases, the patient may benefit from a higher dose of NRT or a combination of products to be able to stay off cigarettes.

Nicotine patch

There are two types of nicotine patches available: a 24-hour release form and a 16-hour release form. They are applied to the skin and changed every day over a total period of about 8–10 weeks. The maximum strength of the 24-hour patch is 21 mg, whereas the maximum strength of the 16-hour patch is 15 mg. Peak action is within 2–9 hours of application. The 21-mg patches are frequently used for 4–6 weeks followed by a short taper (14 mg/d for 2–4 weeks, then 7 mg/d for 2–4 weeks) to wean the patient off of the patches completely.

Advantages of the patch include convenience and a minimal need for instruction.

Disadvantages include mild itching or erythema at the application site and possible allergy to the adhesive. Alternative delivery methods should be considered in patients with eczema or skin conditions. Some patients also develop sleep disturbances, anxiety, appetite disturbances, generalized rash, headache, nausea, vertigo, or dyspepsia.

The 24-hour patch is believed to be more effective against early morning urges but has also been associated with a greater incidence of sleep disturbances. Some of the side effects can be mitigated by removing the patch at bedtime or lowering the dose of the patch in those who experience nicotine overdose symptoms.

Six-month quit rates with the patch range from 22% to 42%, whereas permanent cessation rates range from 5% to 28%.

Nicotine gum and lozenges

Nicotine gum was the first NRT approved for use in the United States and is readily available over-the-counter. The gum is chewed briefly until a tingling sensation is noted, then is “parked” in the mouth. The location of parked gum should be rotated regularly. Each piece of gum is used for about 30 minutes and the effects of the absorbed nicotine peak within 20–40 minutes. Maximum dosing recommendations are 30 pieces of the 2-mg gum, or 20 pieces of the 4-mg gum, per day. It is suggested that patients start with a fixed dose per day (e.g., 1 piece every 1–2 hours) then progressively wean themselves over a total period of about 12 weeks.

The most obvious advantage of this method is that gum chewing is socially acceptable in most settings and the gum can be chewed whenever a patient has a craving.

The disadvantages include a higher level of instruction for proper use and difficulty of use for people with temporomandibular joint problems or dentures, or those who are edentulous. Other disadvantages include air swallowing, hiccups, indigestion, nausea, stomachache, burning sensation in the throat, and a sore jaw. The gum has also been noted to have a bad taste.

Because absorption of the nicotine is based on pH in the oral cavity, ingestion of coffee and carbonated beverages before use may lead to poor absorption. Food intake can also disrupt the absorption. Oftentimes people do not use the correct dosage or amount of the gum during the day to stave off cravings, so education by healthcare personnel is essential. Alternatively, combining a patch and gum or lozenge may be more beneficial than use of either type of NRT alone.

Nicotine lozenges have a similar nicotine delivery system as the gum; dosing is similar. The lozenge should require less instruction than the gum, but have similar efficacy. Patients should not chew or swallow the lozenge, but allow it to dissolve completely in the mouth, which takes about 20–30 minutes. As with the gum, patients should move the lozenge around their mouth and “park” it occasionally.

Nicotine inhaler

A nicotine inhaler consists of nicotine plugs inside hollow cigarette-like rods (a long cartridge). The nicotine levels peak in 10–15 minutes after inhalation. Although it is called an inhaler, 95% of the nicotine is absorbed in the mouth and esophagus, not in the lung. The usual dosing is 6–16 nicotine cartridges per day. One cartridge (10-mg nicotine) is used up after about 20 minutes of active puffing. The recommended duration of treatment is 12 weeks followed by a 6–12-week weaning period.

This form of NRT is especially good for cravings because of the quicker onset of action. It also satisfies the hand-to-mouth ritual of cigarette smoking.

The major disadvantages of this method include awkwardness of using an inhaler in certain social settings, cough, and throat irritation. Patients need a prescription in order to get nicotine inhalers.

Nicotine nasal spray

The nasal spray most closely resembles the effects of actual cigarette smoking because of the high peak blood levels obtained and the rapid onset of action in 5–7 minutes. The levels of nicotine in the blood obtained with this method, although higher than all other forms of NRT, are still lower than levels achieved with cigarette smoking. Maximum dosing is 1 spray per nostril every 1–2 hours, not to exceed 30–40 times per day, for 3 months followed by a tapering period up to 3 months.

The advantage of the nasal spray is that users are able to satisfy cravings rapidly.

The disadvantages include local irritation of the nose, eyes, and throat, as well as headache, burning sensation, sneezing, and watery eyes. Some patients are also embarrassed to use the spray in public. A cold or nasal congestion can also negatively affect absorption. Nicotine nasal spray should be avoided in patients with asthma. Patients need a prescription in order to get nicotine nasal spray.

Nonnicotine pharmacotherapies: Bupropion and varenicline are considered first-line therapies and both require a prescription and close physician monitoring. Both are associated with more adverse side effects than NRT which subsequently affects adherence and quit rates.

Bupropion

The effectiveness of bupropion in smoking cessation is believed to be related to the dopaminergic and noradrenergic effects of the drug. The noradrenergic modifications may limit nicotine withdrawal symptoms, while the dopaminergic modulation may affect areas of the brain that are involved with the reinforcing properties of addictive drugs such as nicotine. Medication should commence 1 week before quitting, at a dose of 150 mg daily for 3 days, and then be increased to 150 mg bid for 7–24 weeks. Although approved at higher doses for use as an antidepressant, 300 mg/dis the maximum dose indicated for smoking cessation. Patients already on bupropion for depression should not be given bupropion for smoking cessation.

Bupropion is in pregnancy category B. It is contraindicated in patients with a seizure history, as it lowers seizure threshold, and it should not be used by patients with anorexia nervosa or bulimia nervosa, patients undergoing alcohol withdrawal, or patients who have used an MAOI in the previous 2 weeks.

Side effects include insomnia, dry mouth, nervousness, difficulty concentrating, rash, and constipation.

A blinded, randomized, placebo-controlled trial demonstrated an 18% success rate with bupropion alone and a 22% success rate with a combination of bupropion and a nicotine patch.⁶ The difference between the groups was not statistically significant, however.

Varenicline

Varenicline is a partial agonist of the nicotinic acetylcholine receptor and helps with reducing nicotine withdrawal symptoms and blocking nicotine from binding to the receptor, therefore taking away the pleasurable effects of smoking. A meta-analysis demonstrated that varenicline was associated with greater abstinence (6 months or greater) compared to bupropion or NRT alone, but not when either was used in combination with other cessation aids.⁷

The starting dose of varenicline is 0.5 mg daily 1 week before the quit date. The dosage is increased to 0.5 mg bid on days 4–7, and finally increased to 1 mg bid until the end of treatment (3–6 months).

Side effects include nausea, strange dreams, neuropsychiatric disorders including depression and mania, and a small, increased risk of cardiovascular adverse events in patients who have cardiovascular disease. Psychiatric risks include changes in behavior, depressed mood, hostility, and suicidal thoughts or actions.

Care shoud be implemented in following patients at a high neuropsychiatric or cardiovascular risk with surveillance and careful screening. Caution is advised in patients with renal insufficiency.

NRT can be used in combination with varenicline in patients who have failed monotherapy.

Other therapies include

Nortriptyline, a tricyclic antidepressant, and other antidepressants are being investigated for efficacy in smoking cessation and have shown modest results. Side effects include dry mouth and sedation. Currently, bupropion remains the only antidepressant that has a smoking cessation indication.

Anxiolytics such as benzodiazepines and buspirone have been used in patients demonstrating increased anxiety during smoking cessation. Although there is no proven benefit for the use of these drugs in smoking cessation, they may be helpful in selected individuals.

Some physicians have tried to diminish withdrawal symptoms through the use of clonidine. There is little evidence to support the use of clonidine in smoking cessation.

There is no convincing evidence that naloxone or naltrexone is effective in smoking cessation.

Other Nonpharmacologic Therapies

• Behavioral counseling

Nonpharmacologic therapies are a helpful adjunct to medical therapy, and there is ample evidence that counseling improves a patient’s chance of quitting. Most studies of smoking cessation have a counseling component or, at the very minimum, regular appointments with counselors to reinforce and remind patients of their goal to quit.

Counseling and support are now available through a variety of media and locations based on patient preference.

Any amount of counseling is known to be effective, even if it is simply a physician advising a smoker to quit. Studies have demonstrated that brief interventions by physicians, often no longer than 3–10 minutes, can increase cessation rates.

There seems to be a dose–response relationship between counseling intensity and effectiveness. High-intensity counseling lasting >30 minutes or at more than two visits is even more effective than brief interventions.

The components of successful smoking cessation counseling therapy are variable and center mostly on cognitive behavior therapy. Some of the ideas discussed include self-management or patient awareness of personal cues and patterns that encourage smoking and how to avoid them. Relapse prevention can also be important, for example, some patients may need to avoid going to bars or drinking alcoholic beverages if such activities trigger a relapse to smoking. Avoiding other smokers is often helpful.

Smoking cessation groups are often organized by hospitals or workplaces with the assistance of the American Lung Association and can be very helpful. They allow smokers to share their difficulties in a group setting. Most states have telephone quit lines that patients can call at any time to get assistance with quitting.

Several websites and computer-based programs can be used in the privacy of one’s own home and have been found to be helpful in maintaining abstinence. Resources online include www.becomeanex.org, www.ffsonline.org, and www.smokefree.gov. Accessed 12/10/15.

Hospitalized smokers provide a unique opportunity for aggressive inpatient counseling by medical personnel. Most US medical campuses are now smoke-free. Patients can be closely monitored for nicotine withdrawal side effects. NRT can be instrumental in the hospital and should be offered to patients by admitting physicians.

• Alternative therapies

Other aids that are used commercially but are unproven include hypnosis, auricular therapy, acupuncture or acupressure, biofeedback, relaxation or meditation, herbal remedies, teas, or supplements.

Other nicotine products are available commercially and are not regulated by the FDA, but may be increasingly used by smokers trying to quit or replace cigarettes (i.e., electronic cigarettes).

Nicotine fading involves systematized cutting back and some studies have shown that patients who are able to successfully cutback have a higher likelihood of quitting.

MONITORING/FOLLOW-UP

• Nicotine affects the metabolism of several medications including warfarin (increased metabolism), heparin (increased clearance), and theophylline (decreased levels) and physicians should carefully review the medication list of patients who are quitting or have recently quit.

• For previous smokers who quit in the distant past, no further intervention is needed. They should, however, be congratulated on their achievement.

• For smokers who quit within the past year, reinforcement is given along with reeducation on the benefits of having quit. Discuss any problems that might have been encountered and their possible solutions. Again, congratulations are in order.

PROGNOSIS

• Many of the health risks of smoking are drastically reduced upon cessation of tobacco smoking.

• The risk of smoking relapse remains high and physicians should be understanding about relapses. Physicians and patients need to evaluate the causes for relapse and underscore the importance of trying to quit again.

REFERENCES

1. Agaku IT, King BA, Dube SR. Current cigarette smoking among adults—United States, 2005–2012. MMWR Morb Mort Wkly Rep. 2014;63:29–34.

2. Heatherton TF, Kozlowski LT, Frecker RC, et al. The Fagerström test for nicotine dependence: a revision of the Fagerström Tolerance Questionnaire. Br J Addict. 1991;86:1119–27.

3. Fiore MC, Bailey WC, Cohen SJ, et al. Treating tobacco use and dependence. Quick reference guide for clinicians. Rockville, MD: US Department of Health and Human Services; 2000. www.surgeongeneral.gov/tobacco/tobaqrg.htm

4. Hughes JR, Rennard SI, Fingar JR, et al. Efficacy of varenicline to prompt quit attempts in smokers not currently trying to quit: a randomized placebo-controlled trial. Nicotine Tob Res. 2011;13(10):955–64.

5. Zapawa LM, Hughes JR, Benowitz NL, et al. Cautions and warnings on the US OTC label for nicotine replacement: what’s a doctor to do? Addictive Behaviors. 2011;36:327–32.

6. Fiore MC, Baker TD, Bailey WC, et al. A clinical practice guideline for treating tobacco use and dependence: 2008 update. A U.S. Public Health Service Report. Am J Prev Med. 2008;35(2):158–76.

7. Cahill K, Stevens S, Perera R, et al. Pharmacological interventions for smoking cessation: an overview and network meta-analysis. Cochrane Database Syst Rev. 2013;5:CD009329.

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