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This section of the Guideline presents specific strategies to guide clinicians providing brief interventions (less than 10 minutes). These brief interventions can be provided by all clinicians but are most relevant to clinicians who see a wide variety of patients and are bound by time constraints (e.g., physicians, nurses, physician assistants, nurse practitioners, medical assistants, dentists, hygienists, respiratory therapists, mental health counselors, pharmacists, etc.). The strategies in this chapter are based on the evidence described in Chapters 6 and 7, as well as on Panel opinion. Guideline analysis suggests that a wide variety of clinicians can implement these strategies effectively.
Why should members of a busy clinical team consider making the treatment of tobacco use a priority? The evidence is compelling: (1) clinicians can make a difference with even a minimal (less than 3 minutes) intervention (see Chapter 6); (2) a relation exists between the intensity of intervention and tobacco cessation outcome (see Chapter 6); (3) even when patients are not willing to make a quit attempt at this time, clinician-delivered brief interventions enhance motivation and increase the likelihood of future quit attempts122 (see Chapter 6); (4) tobacco users are being primed to consider quitting by a wide range of societal and environmental factors (e.g., public health messages, policy changes, cessation marketing messages, family members); (5) there is growing evidence that smokers who receive clinician advice and assistance with quitting report greater satisfaction with their health care than those who do not;23,87,88 (6) tobacco use interventions are highly cost effective (see Chapter 6); and (7) tobacco use has a high case fatality rate (up to 50% of long-term smokers will die of a smoking-caused disease123).
The goal of these strategies is clear: to change clinical culture and practice patterns to ensure that every patient who uses tobacco is identified, advised to quit, and offered scientifically sound treatments. The strategies underscore a central theme: it is essential to provide at least a brief intervention to every tobacco user at each health care visit. Responsibility lies with both the clinician and the health care system to ensure that this occurs. Several observations are relevant to this theme. First, although many smokers are reluctant to seek intensive treatments,124,125 they nevertheless can receive a brief intervention every time they visit a clinician.66,126 Second, institutional support is necessary to ensure that all patients who use tobacco are identified and offered appropriate treatment (see Chapter 5, Systems Interventions: Importance to Health Care Administrators, Insurers, and Purchasers). Third, the time limits on primary care physicians in the United States today (median visit = 12–16 minutes),127,128 as well as reimbursement restrictions, often limit providers to brief interventions, although more intensive interventions would produce greater success. Finally, given the growing use of electronic patient databases, smoker registries, and real-time clinical care prompts, brief interventions may be easier to fit into a busy practice and may be implemented in a variety of ways.
This chapter is divided into three sections to guide brief clinician interventions with three types of patients: (A) current tobacco users willing to make a quit attempt at this time; (B) current tobacco users unwilling to make a quit attempt at this time; and (C) former tobacco users who have recently quit. Patients who have never used tobacco or who have been abstinent for an extended period should be congratulated on their status and encouraged to maintain their tobacco-free lifestyle.
| Ask about tobacco use. | Identify and document tobacco use status for every patient at every visit. (Strategy A1) |
| Advise to quit. | In a clear, strong, and personalized manner, urge every tobacco user to quit. (Strategy A2) |
| Assess willingness to make a quit attempt. | Is the tobacco user willing to make a quit attempt at this time? (Strategy A3) |
| Assist in quit attempt. | For the patient willing to make a quit attempt, offer medication and provide or refer for counseling or additional treatment to help the patient quit. (Strategy A4) For patients unwilling to quit at the time, provide interventions designed to increase future quit attempts. (Strategies B1 and B2) |
| Arrange followup. | For the patient willing to make a quit attempt, arrange for followup contacts, beginning within the first week after the quit date. (Strategy A5) For patients unwilling to make a quit attempt at the time, address tobacco dependence and willingness to quit at next clinic visit. |
| Who should receive medication for tobacco use? Are there groups of smokers for whom medication has not been shown to be effective? | All smokers trying to quit should be offered medication, except when contraindicated or for specific populations for which there is insufficient evidence of effectiveness (i.e., pregnant women, smokeless tobacco users, light smokers, and adolescents; see Chapter 7). |
| What are the first-line medications recommended in this Guideline update? | All seven of the FDA-approved medications for treating tobacco use are recommended: bupropion SR, nicotine gum, nicotine inhaler, nicotine lozenge, nicotine nasal spray, nicotine patch, and varenicline. The clinician should consider the first-line medications shown to be more effective than the nicotine patch alone: 2 mg/day varenicline or the combination of long-term nicotine patch use + ad libitum nicotine replacement therapy (NRT). Unfortunately, there are no well-accepted algorithms to guide optimal selection among the first-line medications. |
| Are there contraindications, warnings, precautions, other concerns, and side effects regarding the first-line medications recommended in this Guideline update? | All seven FDA-approved medications have specific contraindications, warnings, precautions, other concerns, and side effects. Refer to FDA package inserts for this complete information and FDA updates to the individual drug tables in this document (Tables 3.3–3.9). (See information below regarding second-line medications.) |
| What other factors may influence medication selection? | Pragmatic factors also may influence selection, such as insurance coverage, out-of-pocket patient costs, likelihood of adherence, dentures when considering the gum, or dermatitis when considering the patch. |
| Is a patient's prior experience with a medication relevant? | Prior successful experience (sustained abstinence with the medication) suggests that the medication may be helpful to the patient in a subsequent quit attempt, especially if the patient found the medication to be tolerable and/or easy to use. However, it is difficult to draw firm conclusions from prior failure with a medication. Some evidence suggests that re-treating relapsed smokers with the same medication produces small or no benefit,142,143 whereas other evidence suggests that it may be of substantial benefit.144 |
| What medications should a clinician use with a patient who is highly nicotine dependent? | The higher-dose preparations of nicotine gum, patch, and lozenge have been shown to be effective in highly dependent smokers.145–147 Also, there is evidence that combination NRT therapy may be particularly effective in suppressing tobacco withdrawal symptoms.148,149 Thus, it may be that NRT combinations are especially helpful for highly dependent smokers or those with a history of severe withdrawal. |
| Is gender a consideration in selecting a medication? | There is evidence that NRT can be effective with both sexes;150–152 however, evidence is mixed as to whether NRT is less effective in women than men.153–157 This may encourage the clinician to consider use of another type of medication with women, such as bupropion SR or varenicline. |
| Are cessation medications appropriate for light smokers (i.e., < 10 cigarettes/day)? | As noted above, cessation medications have not been shown to be beneficial to light smokers. However, if NRT is used with light smokers, clinicians may consider reducing the dose of the medication. No adjustments are necessary when using bupropion SR or varenicline. |
| When should second-line agents be used for treating tobacco dependence? | Consider prescribing second-line agents (clonidine and nortriptyline) for patients unable to use first-line medications because of contraindications or for patients for whom the group of first-line medications has not been helpful. Assess patients for the specific contraindications, precautions, other concerns, and side effects of the second-line agents. Refer to FDA package inserts for this information and to the individual drug tables in this document (Tables 3.10 and 3.11). |
| Which medications should be considered with patients particularly concerned about weight gain? | Data show that bupropion SR and nicotine replacement therapies, in particular 4-mg nicotine gum and 4-mg nicotine lozenge, delay—but do not prevent—weight gain. |
| Are there medications that should especially be considered for patients with a past history of depression? | Bupropion SR and nortriptyline appear to be effective with this population158–162 (see Chapter 7), but nicotine replacement medications also appear to help individuals with a past history of depression. |
| Should nicotine replacement therapies be avoided in patients with a history of cardiovascular disease? | No. The nicotine patch in particular has been demonstrated as safe for cardiovascular patients. See Tables 3.3–3.9 and FDA package inserts for more complete information. |
| May tobacco dependence medications be used long-term (e.g., up to 6 months)? | Yes. This approach may be helpful with smokers who report persistent withdrawal symptoms during the course of medications, who have relapsed in the past after stopping medication, or who desire long-term therapy. A minority of individuals who successfully quit smoking use ad libitum NRT medications (gum, nasal spray, inhaler) long-term. The use of these medications for up to 6 months does not present a known health risk, and developing dependence on medications is uncommon. Additionally, the FDA has approved the use of bupropion SR, varenicline, and some NRT medications for 6-month use. |
| Is medication adherence important? | Yes. Patients frequently do not use cessation medications as recommended (e.g., they do not use them at recommended doses or for recommended durations); this may reduce their effectiveness. |
| May medications ever be combined? | Yes. Among first-line medications, evidence exists that combining the nicotine patch long-term ( > 14 weeks) with either nicotine gum or nicotine nasal spray, the nicotine patch with the nicotine inhaler, or the nicotine patch with bupropion SR, increases long-term abstinence rates relative to placebo treatments. Combining varenicline with NRT agents has been associated with higher rates of side effects (e.g., nausea, headaches). |
| Clinical use of nortriptyline (not FDA approved for smoking cessation) | |
|---|---|
| Patient selection | Appropriate as a second-line medication for treating tobacco use |
| Precautions, warnings, contraindications, and side effects (see FDA package insert for complete list) | Pregnancy - Pregnant smokers should be encouraged to quit without medication. Nortriptyline has not been shown to be effective for tobacco cessation in pregnant smokers. (Nortriptyline is an FDA pregnancy Class D agent.) Nortriptyline has not been evaluated in breastfeeding patients. Side effects - Most commonly reported side effects include sedation, dry mouth (64–78%), blurred vision (16%), urinary retention, lightheadedness (49%), and shaky hands (23%). Activities - Nortriptyline may impair the mental and/or physical abilities required for the performance of hazardous tasks, such as operating machinery or driving a car; therefore, the patient should be warned accordingly. Cardiovascular and other effects - Because of the risk of arrhythmias and impairment of myocardial contractility, use with caution in patients with cardiovascular disease. Do not co-administer with MAO inhibitors. |
| Dosage | Doses used in smoking cessation trials have initiated treatment at a dose of 25 mg/day, increasing gradually to a target dose of 75–100 mg/day. Duration of treatment used in smoking cessation trials has been approximately 12 weeks, although clinicians may consider extending treatment for up to 6 months. |
| Availability | Nortriptyline HCl - prescription only |
| Prescribing instructions | Initiate - Therapy is initiated 10–28 days before the quit date to allow nortriptyline to reach steady state at the target dose. Therapeutic monitoring - Although therapeutic blood levels for smoking cessation have not been determined, therapeutic monitoring of plasma nortriptyline levels should be considered under American Psychiatric Association Guidelines for treating patients with depression. Clinicians may choose to assess plasma nortriptyline levels as needed.163Dosing information - Users should not discontinue nortriptyline abruptly because of withdrawal effects. Overdose may produce severe and life-threatening cardiovascular toxicity, as well as seizures and coma. Risk of overdose should be considered carefully before using nortriptyline. |
| Costa | 25 mg, box of 60 = $24 (daily dosage determines how long supply lasts) |
Cost data were established by averaging the retail price of the medication at national chain pharmacies in Atlanta, GA, Los Angeles, CA, Milwaukee, WI, Sunnyside, NY, and listed online during January 2008 and may not reflect discounts available to health plans and others.
| Action | Strategies for implementation |
|---|---|
| Implement an officewide system that ensures that, for every patient at every clinic visit, tobacco use status is queried and documented.a | Expand the vital signs to include tobacco use, or use an alternative universal identification system.bVITAL SIGNS Blood Pressure: _______________________ Pulse: ________ Weight: ___________ Temperature: _________________________ Respiratory Rate: ______________________ Tobacco Use (circle one): Current Former Never |
Repeated assessment is not necessary in the case of the adult who has never used tobacco or has not used tobacco for many years and for whom this information is clearly documented in the medical record.
Alternatives to expanding the vital signs include using tobacco use status stickers on all patient charts or indicating tobacco use status via electronic medical records or computerized reminder systems.
| Action | Strategies for implementation |
|---|---|
| In a clear, strong, and personalized manner, urge every tobacco user to quit. | Advice should be:
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| Action | Strategies for implementation |
|---|---|
| Assess every tobacco user's willingness to make a quit attempt at the time. | Assess patient's willingness to quit: “Are you willing to give quitting a try?”
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| Action | Strategies for implementation |
|---|---|
| Help the patient with a quit plan. | A patient's preparations for quitting:
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| Recommend the use of approved medication, except when contraindicated or with specific populations for which there is insufficient evidence of effectiveness (i.e., pregnant women, smokeless tobacco users, light smokers, and adolescents). | Recommend the use of medications found to be effective in this Guideline (see Table 3.2 for clinical guidelines and Tables 3.3–3.11 for specific instructions and precautions). Explain how these medications increase quitting success and reduce withdrawal symptoms. The first-line medications include: bupropion SR, nicotine gum, nicotine inhaler, nicotine lozenge, nicotine nasal spray, nicotine patch, and varenicline; second-line medications include: clonidine and nortriptyline. There is insufficient evidence to recommend medications for certain populations (e.g., pregnant women, smokeless tobacco users, light smokers, adolescents). |
| Provide practical counseling (problemsolving/skills training). | Abstinence. Striving for total abstinence is essential. Not even a single puff after the quit date.141Past quit experience. Identify what helped and what hurt in previous quit attempts. Build on past success. Anticipate triggers or challenges in the upcoming attempt. Discuss challenges/triggers and how the patient will successfully overcome them (e.g., avoid triggers, alter routines). Alcohol. Because alcohol is associated with relapse, the patient should consider limiting/abstaining from alcohol while quitting. (Note that reducing alcohol intake could precipitate withdrawal in alcohol-dependent persons.) Other smokers in the household. Quitting is more difficult when there is another smoker in the household. Patients should encourage housemates to quit with them or to not smoke in their presence. For further description of practical counseling, see Table 6.19. |
| Provide intratreatment social support. | Provide a supportive clinical environment while encouraging the patient in his or her quit attempt. “My office staff and I are available to assist you.”“I'm recommending treatment that can provide ongoing support.” For further description of intratreatment social support, see Table 6.20. |
| Provide supplementary materials, including information on quitlines. | Sources: Federal agencies, nonprofit agencies, national quitline network (1-800-QUIT-NOW), or local/state/tribal health departments/quitlines (see Appendix B for Web site addresses). Type: Culturally/racially/educationally/age-appropriate for the patient. Location: Readily available at every clinician's workstation. |
| For the smoker unwilling to quit at the time | See Section 3B. |
| Action | Strategies for implementation |
|---|---|
| Arrange for followup contacts, either in person or via telephone. | Timing: Followup contact should begin soon after the quit date, preferably during the first week. A second followup contact is recommended within the first month. Schedule further followup contacts as indicated. Action during followup contact: For all patients, identify problems already encountered and anticipate challenges in the immediate future. Assess medication use and problems. Remind patients of quitline support (1-800-QUIT-NOW). Address tobacco use at next clinical visit (treat tobacco use as a chronic disease). For patients who are abstinent, congratulate them on their success. If tobacco use has occurred, review circumstances and elicit recommitment to total abstinence. Consider use of or link to more intensive treatment (see Chapter 4). |
| For smokers unwilling to quit at the time | See Section 3B. |
All patients entering a health care setting should have their tobacco use status assessed routinely. Clinicians should advise all tobacco users to quit and then assess a patient's willingness to make a quit attempt. For patients not ready to make a quit attempt at the time, clinicians should use a brief intervention designed to promote the motivation to quit.
Patients unwilling to make a quit attempt during a visit may lack information about the harmful effects of tobacco use and the benefits of quitting, may lack the required financial resources, may have fears or concerns about quitting, or may be demoralized because of previous relapse.164–167 Such patients may respond to brief motivational interventions that are based on principles of Motivational Interviewing (MI),168 a directive, patient-centered counseling intervention.169 There is evidence that MI is effective in increasing future quit attempts;170–174 however, it is unclear that MI is successful in boosting abstinence among individuals motivated to quit smoking.173,175,176
Clinicians employing MI techniques focus on exploring a tobacco user's feelings, beliefs, ideas, and values regarding tobacco use in an effort to uncover any ambivalence about using tobacco.169,177,178 Once ambivalence is uncovered, the clinician selectively elicits, supports, and strengthens the patient's “change talk” (e.g., reasons, ideas, needs for eliminating tobacco use) and “commitment language” (e.g., intentions to take action to change smoking behavior, such as not smoking in the home). MI researchers have found that having patients use their own words to commit to change is more effective than clinician exhortations, lectures, or arguments for quitting, which tend to increase rather than lessen patient resistance to change.177
Smokers who have recently quit face a high risk of relapse. Although most relapse occurs early in the quitting process,96,101,181 some relapse occurs months or even years after the quit date.181–184 Numerous studies have been conducted to identify treatments that can reduce the likelihood of future relapse. These studies attempt to reduce relapse either by including special counseling or therapy in the cessation treatment, or by providing additional treatment to smokers who have previously quit. In general, such studies have failed to identify either counseling or medication treatments that are effective in lessening the likelihood of relapse,185 although there is some evidence that special mailings can reduce the likelihood of relapse.186,187 Thus, at present, the best strategy for producing high long-term abstinence rates appears to be use of the most effective cessation treatments available; that is, the use of evidence-based cessation medication during the quit attempt and relatively intense cessation counseling (e.g., four or more sessions that are 10 minutes or more in length).
| A patient who previously smoked might identify a problem that negatively affects health or quality of life. Specific problems likely to be reported by former smokers and potential responses follow: | |
| Problems | Responses |
| Lack of support for cessation |
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| Negative mood or depression |
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| Strong or prolonged withdrawal symptoms |
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| Weight gain |
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| Smoking lapses |
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