Treating Tobacco Use and Dependence

Treating Tobacco Use and Dependence 2008 UPDATE U.S. Public Health ServiceClinical Practice Guideline

2008 PHS Clinical Practice Guideline Update: Treating Tobacco Use and Dependence • Brief history and developmental process • Key findings of interest • Getting more information

2008 PHS Clinical Practice Guideline Update: Treating Tobacco Use and Dependence • Brief history and developmental process

2008 PHS Clinical Practice Guideline: Treating Tobacco Use and Dependence Update History: • 1996—Initial Guideline published; literature from 1975–1995; approximately 3,000 articles • 2000—Revised Guideline published; literature from 1995–1999; approximately 6,000 articles • 2008—Updated Guideline published; literature from 1999–2007; approximately 8,700 total articles

2008 PHS Clinical Practice Guideline: Treating Tobacco Use and Dependence Update • Update process started 7-1-06 • Scope remains the treatment of tobacco use and dependence • Update rather than a full rewrite • Used very similar development process

Funded by • Agency for Healthcare Research and Quality • National Cancer Institute • National Heart, Lung & Blood Institute • National Institute on Drug Abuse • Centers for Disease Control and Prevention • The Robert Wood Johnson Foundation • American Legacy Foundation • University of Wisconsin-Center for Tobacco Research and Intervention

Panel Members Howard Koh, MD, MPH, FACP Thomas E. Kottke, MD, MSPH Harry A. Lando, PhD Robert Mecklenburg, DDS, MPH Robin Mermelstein, PhD Patricia Mullen, Dr PH C. Tracy Orleans, PhD Lawrence Robinson, MD, MPH Maxine Stitzer, PhD Anthony Tommasello, Pharm BS, PhD Louise Villejo, MPH, CHES Mary Ellen Wewers, PhD, RN, MPH Michael C. Fiore, MD, MPH, Chair Carlos Roberto Jaén, MD, PhD, FAAFP, Vice-Chair Timothy Baker, PhD, Senior Scientist William C. Bailey, MD, FACP, FCCP Neal Benowitz, MD Susan J. Curry, PhD Sally Faith Dorfman, MD, MSHSA Erika S. Froelicher, RN, MA, MPH, PhD Michael G. Goldstein, MD Cheryl Healton, DrPH Patricia Nez Henderson, MD, MPH Richard B. Heyman, MD

PHS Liaisons • Ernestine (Tina) Murray, AHRQ (Project Officer) • Christine Williams, AHRQ • Glen Bennett, NHLBI • Stephen Heishman, NIDA • Corrine Husten, CDC • Glen Morgan, NCI

Guideline Update Development Phases 1. Identify update topics 2. Meta-analysis of topics 3. Panel/liaisons workgroups 4. Establish recommendations and other content 5. Draft text 6. Peer review/public comment 7. Released – May 7, 2008* * Full Guideline, including detailed financial disclosure information, available at www.surgeongeneral.gov/tobacco

Final Selected Topics • Proactive quitlines • Combining counseling and medication relative to either counseling or medication alone • Varenicline • Various medication combinations • Long-term medication use • Tobacco use interventions for individuals with low socio-economic status/limited formal education • Tobacco use interventions for adolescent smokers • Tobacco use interventions for pregnant smokers • Tobacco use interventions for individuals with psychiatric disorders, including substance abuse disorders • Providing cessation interventions as a health benefit • Systems interventions, including provider training and the combination of training and systems interventions

Peer Review/Public Comment • Over 90 independent tobacco treatment experts served as peer reviewers • Federal Register notice announced availability of guideline for public comment

2008 PHS Clinical Practice Guideline Update: Treating Tobacco Use and Dependence • Brief history and developmental process • Key findings of interest

Combinations: Medication and Counseling Effectiveness of and estimated abstinence rates for the combination of counseling and medication versus medication alone (n = 18 studies)

Combinations: Medication and Counseling Effectiveness of and estimated abstinence rates for the combination of counseling and medication versus counseling alone (n = 9 studies)

Combining Counseling and Medication Recommendation: The combination of counseling and medication is more effective for smoking cessation than either medication or counseling alone. Therefore, whenever feasible and appropriate, both counseling and medication should be provided to patients trying to quit smoking. (Strength of Evidence = A). Recommendation: There is a strong relation between the number of sessions of counseling when it is combined with medication, and the likelihood of successful smoking cessation. Therefore, to the extent possible, clinicians should provide multiple counseling sessions, in addition to medication, to their patients who are trying to quit smoking. (Strength of Evidence = A). TreatmentRecommendations –Counseling

Strength of Evidence for Recommendations

Pro-Active Quitlines Effectiveness of and estimated abstinence rates for quitline counseling compared to minimal interventions, self-help or no counseling (n = 9 studies)

Pro-Active Quitlines Effectiveness of and estimated abstinence rates for quitline counseling and medication compared to medication alone (n = 6 studies)

Medication Seven first-line medications shown to be effective and recommended for use by the Guideline Panel: • Bupropion SR • Nicotine Gum • Nicotine Inhaler • Nicotine Lozenge • Nicotine Nasal Spray • Nicotine Patch • Varenicline

Varenicline Effectiveness and abstinence rates for various medications and medication combinations compared to placebo at 6-months post-quit (n = 86 studies)

Nicotine Lozenge Effectiveness of the nicotine lozenge: Results from the single randomized controlled trial.

Relative Efficacy 22 22

Medication Recommendation Recommendation: Certain combinations of first-line medications have been shown to be effective smoking cessation treatments. Therefore, clinicians should consider using these combinations of medications with their patients who are willing to quit. Effective combination medications are: * Long-term (> 14 weeks) nicotine patch + other NRT (gum and spray) * The nicotine patch + the nicotine inhaler * The nicotine patch + bupropion SR. (Strength of Evidence = A)

Specific Populations • Children and Adolescent Smokers • Light Smokers • Noncigarette Tobacco Users • Pregnant Smokers

HIV-positive smokers Hospitalized smokers Lesbian/gay/bisexual/ transgender smokers Smokers with low SES/limited formal education Smokers with medical comorbidities Older smokers Smokers with psychiatric disorders including substance use disorders Racial and ethnic minority smokers Women smokers Special Populations

Low Socio-Economic Status/Limited Formal Education Effectiveness of and estimated abstinence rates for counseling interventions with low socio-economic status/limited formal education (n = 5 studies)

Psychiatric Disorders Including Substance Use Disorders Effectiveness of and estimated abstinence rates for treatment with bupropion and nortryptyline for smokers with a history of depression (n = 4 studies)

Specific Populations and Other Topics Recommendation: The interventions found to be effective in this Guideline have been shown to be effective in a variety of populations. In addition, many of the studies supporting these interventions comprised diverse samples of tobacco users. Therefore, interventions identified as effective in this Guideline are recommended for all individuals who use tobacco except when medication use is contraindicated or with specific populations in which medication has not been shown to be effective (pregnant women, smokeless tobacco users, light smokers and adolescents). (Strength of Evidence = B).

Adolescent Smokers Effectiveness of and estimated abstinence rates for counseling interventions with adolescent smokers (n = 7 studies)

Children and Adolescents: Recommendation: Clinicians should ask pediatric and adolescent patients about tobacco use and provide a strong message regarding the importance of totally abstaining from tobacco use. (Strength of Evidence = C) Recommendation: Counseling has been shown to be effective in treatment of adolescent smokers. Therefore, adolescent smokers should be provided with counseling interventions to aid them in quitting smoking. (Strength of Evidence = B) Recommendation: Second-hand smoke is harmful to children. Cessation counseling delivered in pediatric settings has been shown to be effective in increasing abstinence among parents who smoke. Therefore, in order to protect children from second-hand smoke, clinicians should ask parents about tobacco use and offer them cessation advice and assistance. (Strength of Evidence = B) Adolescent Smokers

Pregnant Smokers Effectiveness of and estimated pre-parturition abstinence rates for psychosocial interventions with pregnant smokers (n = 8 studies)

Recommendation: Because of the serious risks of smoking to the pregnant smoker and the fetus, whenever possible pregnant smokers should be offered person-to-person psychosocial interventions that exceed minimal advice to quit. (Strength of Evidence = A) Recommendation: Although abstinence early in pregnancy will produce the greatest benefits to the fetus and expectant mother, quitting at any point in pregnancy can yield benefits. Therefore, clinicians should offer effective tobacco dependence interventions to pregnant smokers at the first prenatal visit as well as throughout the course of pregnancy. (Strength of Evidence = B) Pregnant Smokers

System Recommendations • Intervention as a covered health care benefit • Clinician training and chart reminders • Tobacco dependence treatment as a part of assessing health care quality • Cost-effectiveness of tobacco dependence Interventions

Intervention as a Covered Health Benefit Estimated rates of quit attempts for individuals who received tobacco use interventions as a covered health insurance benefit (n = 3 studies)

Intervention as a Covered Health Benefit Estimated abstinence rates for individuals who received tobacco use interventions as a covered benefit (n = 3 studies)

Intervention as a Covered Health Benefit Recommendation: Providing tobacco dependence treatments (both medication and counseling) as a paid or covered benefit by health insurance plans has been shown to increase the proportion of smokers who use cessation treatment, attempt to quit, and successfully quit. Therefore, treatments shown to be effective in the Guideline should be included as covered services in public and private health benefit plans.(Strength of Evidence = A).

Systems Interventions:Clinician Training and Chart Reminders Effectiveness of clinician training combined with charting on asking about smoking status (“Ask”) (n = 3 studies)

Systems Interventions:Clinician Training and Chart Reminders Effectiveness of training combined with charting on setting a quit date (“Assist”) (n = 2 studies)

Systems Interventions:Clinician Training and Chart Reminders Effectiveness of training combined with charting on arranging for follow-up (“Arrange”) (n = 2 studies)

Systems Interventions:Clinician Training and Chart Reminders Clinician Training and Reminder Systems: Recommendation: All clinicians and clinicians-in-training should be trained in effective strategies to assist tobacco users willing to make a quit attempt and to motivate those unwilling to quit. Training appears to be more effective when coupled with systems changes. (Strength of Evidence = B).

For Smokers Not Willing To Make a Quit Attempt at This Time Recommendation: Motivational intervention techniques appear to be effective in increasing a patient’s likelihood of making a future quit attempt. Therefore, clinicians should use motivational techniques to encourage smokers who are not currently willing to quit to consider making a quit attempt in the future. (Strength of Evidence = B).

The "5 A's" Model for Treating Tobacco Use and Dependence - 2000 Ask about tobacco use. Identify and document tobacco use status for every patient at every visit. Adviseto quit. In a clear, strong and personalized manner urge every tobacco user to quit. Assesswillingness to make a quit attempt. Is the tobacco user willing to make a quit attempt at this time? Assist in quit attempt. For the patient willing to make a quit attempt, use counseling or pharmacotherapy to help him or her quit. Arrangefollowup. Schedule followup contact, preferably within the first week after the quit date.

The "5 A's" Model for Treating Tobacco Use and Dependence - 2008 Ask about tobacco use. Identify and document tobacco use status for every patient at every visit. Advise to quit. In a clear, strong and personalized manner urge every tobacco user to quit. Assess willingness to make a quit attempt. Is the tobacco user willing to make a quit attempt at this time? 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. For patients unwilling to quit at the time, provide interventions designed to increase future quit attempts. Arrange followup. For the patient willing to make a quit attempt, arrange for follow-up contacts, beginning within the first week after the quit date. For patients unwilling to make a quit attempt at the time, address tobacco dependence and willingness to quit at next clinic visit.

The "5 A's" Model for Treating Tobacco Use and Dependence - 2008

10 Key Guideline Recommendations 10

10 Key Guideline Recommendations • Tobacco dependence is a chronic disease that often requires repeated intervention and multiple attempts to quit. However, effective treatments exist that can significantly increase rates of long-term abstinence. • It is essential that clinicians and healthcare delivery systems consistently identify and document tobacco use status and treat every tobacco user seen in a healthcare setting.

10 Key Guideline Recommendations 3. Tobacco dependence treatments are effective across a broad range of populations. Clinicians should encourage every patient willing to make a quit attempt to use the counseling treatments and medications recommended in this Guideline.

10 Key Guideline Recommendations • Brief tobacco dependence treatment is effective. Clinicians should offer every patient who uses tobacco at least the brief treatments shown to be effective in this Guideline. 5. Individual, group and telephone counseling are effective, and their effectiveness increases with treatment intensity. Two components of counseling are especially effective and clinicians should use these when counseling patients making a quit attempt. • Practical counseling (problemsolving/skills training) • Social support delivered as part of treatment

10 Key Guideline Recommendations 6. There are numerous effective medications for tobacco dependence and clinicians should encourage their use by all patients attempting to quit smoking, except when medically contraindicated or with specific populations for which there is insufficient evidence of effectiveness (i.e., pregnant women, smokeless tobacco users, light smokers and adolescents). • Seven first-line medications (5 nicotine and 2 non-nicotine) reliably increase long-term smoking abstinence rates: Clinicians should also consider the use of certain combinations of medications identified as effective in this Guideline.

10 Key Guideline Recommendations 7.Counseling and medication are effective when used by themselves for treating tobacco dependence. However, the combination of counseling and medication is more effective than either alone. Thus, clinicians should encourage all individuals making a quit attempt to use both counseling and medication. 8. Telephone quitline counseling is effective with diverse populations and has broad reach. Therefore, clinicians and healthcare delivery systems should both ensure patient access to quitlines and promote quitline use.

Treating Tobacco Use and Dependence