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Smoking Cessation

By Douglas E. Jorenby, PhD, Professor of Medicine;Director of Clinical Services, University of Wisconsin School of Medicine and Public Health;University of Wisconsin Center for Tobacco Research and Intervention

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Patient Education

Most smokers want to quit and have tried doing so with limited success. Effective interventions include cessation counseling and drug treatment, such as varenicline, bupropion, or a nicotine replacement product.

About 70% of US smokers say they want to quit and have already tried to quit at least once. Among the barriers are withdrawal symptoms.


Withdrawal symptoms are often powerful enough that even with knowledge of the health risks, many smokers are unwilling to try quitting. Smoking cessation can cause intense symptoms, including strong cravings for cigarettes, but also often anxiety, depression (mostly mild, sometimes major), inability to concentrate, irritability, restlessness, insomnia, hunger, headaches, GI disturbances, and sleep disruption. These symptoms are worst in the first week (when most smokers trying to quit relapse) and most subside within 2 wk in most smokers, but some symptoms may continue for months. Weight gain is common; quitters gain an average of 4 to 5 kg, and weight gain is another reason for recidivism. Temporary cough and oral ulcers may develop after quitting.


About 20 million smokers in the US try to quit each year (almost half of all smokers), usually by using a cold turkey or other non-evidence–based approach, resulting in relapse within days, weeks, or months. Many cycle through multiple periods of relapse and remission. The long-term success rate for unassisted quitting is about 5%. In contrast, 1-yr success rates of up to 20 to 30% are achieved among smokers who use evidence-based cessation counseling and recommended drugs.

Among smokers < 18 yr, most believe they will not be smoking in 5 yr, and 40 to 50% report having tried to quit in the previous year. However, longitudinal studies show that overall, 73% of daily smokers in high school remain daily smokers 5 to 6 yr later.


Evidence-based counseling and drug treatment are both effective treatments for tobacco dependence; combining counseling and drug treatment is more effective than either intervention alone. (See also information about tobacco cessation from the US Preventive Services Task Force [Tobacco Smoking Cessation in Adults, Including Pregnant Women: Behavioral and Pharmacotherapy Interventions].)

Smoking has many characteristics of a chronic disorder. Thus, the optimal evidence-based approach to smokers, particularly those unwilling to quit or those who have not yet considered quitting, should be guided by the same principles that guide chronic disease management, namely

  • Continually assessing and monitoring smoking status

  • Using different evidence-based interventions (or combinations) for different patients and building on their prior experiences and treatment preferences

  • Encouraging temporary abstinence and reduction in consumption for patients who fall short of total smoking cessation while emphasizing that abstinence is the ultimate goal

Although reduction in consumption can increase motivation to quit (particularly when combined with nicotine replacement therapy), smokers should be reminded that reducing the number of cigarettes smoked may not improve health because smokers often inhale more smoke (and thus more toxins) per cigarette to maintain nicotine intake when they reduce the number of cigarettes smoked per day.

Evidence-based counseling

Counseling efforts begin with the 5 A’s:

  • Ask at every visit whether a patient smokes and document the response.

  • Advise all smokers to quit in clear, strong, personalized language they will understand.

  • Assess a smoker’s willingness to try quitting within the next 30 days.

  • Assist smokers willing to make a quit attempt by providing brief counseling and drug treatment.

  • Arrange a follow-up, preferably within the first week of the quit date.

For smokers willing to quit, clinicians should establish a quit date, preferably within 2 wk, and stress that total abstinence is better than reduction. Past quitting experiences can be reviewed to identify what helped and what did not, and smoking triggers or challenges to quitting should be planned for in advance. For example, alcohol use is associated with relapse, so alcohol restriction or abstinence should be discussed. In addition, quitting is more difficult with another smoker in the household; spouses and housemates can be encouraged to quit together. In general, smokers should be instructed to develop social support among family and friends for their quit attempt, and clinicians should reinforce their availability and assistance in support of the attempt.

In addition to the brief counseling provided by the smoker’s clinician, counseling programs can help. They usually use cognitive-behavioral techniques and are offered by various commercial and voluntary health programs. Success rates are higher than with self-help programs. All states in the US have telephone quit lines that can provide counseling support (and sometimes nicotine replacement therapy) to smokers trying to quit. People can call 1-800-QUIT-NOW (1-800-784-8669) toll-free anywhere in the US. Quit lines appear to be at least as effective as in-person counseling.

Drugs for smoking cessation

Effective and safe drugs for smoking cessation include varenicline, bupropion SR, and 5 types of nicotine replacement therapy (in the form of gum, lozenge, patch, inhaler, and nasal spray— Drugs for Smoking Cessation). Bupropion’s mechanism may be to increase the brain's release of norepinephrine and dopamine. Varenicline works at the nicotinic acetylcholine receptor (the α-4β-2 subunit), where it acts as a partial agonist, having some nicotinic effects, and as a partial antagonist, blocking the effects of nicotine. Some evidence suggests varenicline is the most effective monotherapy available for smoking cessation.

Research suggests that combinations of different nicotine replacement products are more effective than single products. For example, combining the nicotine patch with a shorter-acting nicotine drug (eg, lozenge, gum, nasal spray, inhaler) is more effective than monotherapy. When used in combination, the patch helps maintain continuous levels, and use of gum, lozenge, inhaler, or nasal spray enables the patient to rapidly increase nicotine levels in response to immediate cravings.

Smokers may worry that they may remain dependent on nicotine after using nicotine products for smoking cessation; however, such dependence rarely persists. Drug choice is guided by the clinician’s familiarity with the drug, the smoker's preference and previous experience (positive or negative), and contraindications.

Despite their proven efficacy, smoking cessation drugs are used by < 25% of smokers attempting to quit. Reasons include low rates of insurance coverage, clinicians' concerns about the side-effects of centrally acting medications (serious neuropsychiatric events including depression, suicidal ideation, and suicide attempt) and the safety of simultaneous smoking and nicotine replacement, and patient discouragement because of past unsuccessful quit attempts.

Therapies under investigation for smoking cessation include the drugs cytisine, bromocriptine, and topiramate. Vaccine therapy was studied and found ineffective.

Drugs for Smoking Cessation




Adverse Effects


Bupropion SR

150 mg every morning for 3 days (beginning 1–2 wk before quitting), then 150 mg twice/day

7–12 wk initially (may continue up to 6 mo)


Dry mouth

Possibly serious neuropsychiatric symptoms* (eg, behavior changes, agitation, depressed mood, suicidal ideation and behavior)

Prescription only

Contraindicated by history of seizure, eating disorder, or MAOI use within the past 2 wk

Nicotine gum

If smoking > 30 min after waking: 2 mg

If smoking< 30 min after waking: 4 mg

Schedule for both dosage strengths:

1 q 1–2 h for wk 1–6

1 q 2–4 h for wk 7–9

1 q 4–8 h for wk 10–12

Up to 6 mo

Mouth soreness


OTC only

Slow chewing recommended to maximize blood levels and minimize gastric and esophageal irritation

Nicotine lozenge

If smoking > 30 min after waking: 2 mg

If smoking< 30 min after waking: 4 mg

Schedule for both dosage strengths:

1 q 1–2 h for wk 1–6

1 q 2–4 h for wk 7–9

1 q 4–8 h for wk 10–12

Up to 6 mo



OTC only

Nicotine inhaler

6–16 cartridges/day for the first 6–12 wk, then tapered down over the next 6–12 wk

3–6 mo

Local irritation of mouth and throat

Prescription only

Nicotine nasal spray

8–40 doses/day

(1 dose = 1 spray in each nostril)

14 wk

Nasal and pharyngeal irritation

Prescription only

Reaches peak blood levels earlier (in 10 min) than other nicotine replacement products

Nicotine patch

21 mg/24 h for 6 wk, then 14 mg/24 h for 2 wk, then 7 mg/24 h for 2 wk

If smoking> 10 cigarettes/day: 21 mg as starting dose

If smoking<10 cigarettes/day: 14 mg as starting dose

10 wk

Local skin reaction


OTC and prescription

Local skin reactions possibly less likely if location of patch is rotated


0.5 mg po once/day for 3 days, then 0.5 mg bid for 4 days, then 1 mg bid

12–24 wk

Most commonly, nausea and sleep disturbances

Possibly serious neuropsychiatric symptoms* (eg, behavior changes, agitation, depressed mood, suicidal ideation and behavior)

Prescription only

*Neuropsychiatric symptoms have been reported, but clinical trial data have not confirmed a causal relationship; detecting such an association may be confounded by the presence of nicotine withdrawal.

The longer duration of treatment may increase the likelihood of long-term abstinence among patients who have stopped smoking after 12 wk of varenicline use.

MAOI = monoamine oxidase inhibitor.

Drug safety

Contraindications to bupropion include a history of seizures, an eating disorder, and monoamine oxidase inhibitor use within 2 wk.

Whether bupropion and varenicline increase risk of suicide is not clear. Varenicline and bupropion may increase risk of serious neuropsychiatric effects and accidents. In 2009, the FDA released a boxed warning for both drugs regarding these possible adverse effects. However, most experts recommend varenicline for most smokers because risks of smoking substantially exceed any possible risks of taking the drug. But varenicline should be avoided in smokers with suicidal risk, unstable psychiatric disorders, and possibly major depression.

Nicotine replacement should be used cautiously in smokers with certain cardiovascular risks (those within 2 wk of an MI, with serious arrhythmias, or with serious angina); however, most data suggest that such use is safe. Nicotine gum is contraindicated in smokers with temporomandibular joint syndrome, and nicotine patches are contraindicated in smokers with severe topical sensitization.

Because of safety concerns, inadequate efficacy data, or both, drugs are not recommended for the following:

  • Pregnant smokers

  • Light smokers (< 10 cigarettes/day)

  • Adolescents (< age 18)

  • Users of smokeless tobacco

Cessation in children

The counseling approach for children is similar to that for adults; however, drugs are not recommended for smokers under the age of 18. (See also the CDC guide for Youth Tobacco Cessation.)

Children should be screened for smoking and risk factors by age 10. Parents should be advised to maintain smoke-free households and to communicate the expectation to their children that the children will remain nonsmokers.

For children who smoke, cognitive-behavioral therapy that involves establishing awareness of tobacco use, providing motivations to quit, preparing to quit, and providing strategies to maintain abstinence after cessation are effective in treating nicotine dependence. Alternative approaches to smoking cessation, such as hypnosis and acupuncture, have not proved to be effective and cannot be recommended for routine use.

Cessation of non-cigarette tobacco products

Cessation counseling for smokeless tobacco users, as for cigarette smokers, has been shown to be effective. However, drugs have not proved effective among smokeless tobacco users.

Effectiveness of cessation treatments for pipe and cigar smokers is not well documented. Also, cessation may be affected by whether cigarettes are smoked concurrently and whether smokers inhale.

Key Points

  • About half of smokers try to quit each year, but few fully succeed.

  • Evidence-based methods of smoking cessation increase the 1-yr success rate from about 5% to 20 to 30%.

  • Use evidence-based counseling methods, including physician counseling and referral to support programs, for patients interested in quitting.

  • Consider drug treatment (eg, with varenicline or combinations of nicotine replacement products).

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