1 Treating Tobacco Use and Dependence 2008 UPDATE U.S. Public Health Service Clinical Practice Guideline

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

PHS 3  Brief history and developmental process 2008 PHS Clinical Practice Guideline Update: Treating Tobacco Use and Dependence

PHS 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

PHS 5  Update process started  Scope remains the treatment of tobacco use and dependence  Update rather than a full rewrite  Used very similar development process 2008 PHS Clinical Practice Guideline: Treating Tobacco Use and Dependence Update

PHS 6 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

PHS 7 Panel Members 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 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

PHS 8 PHS Liaisons  Ernestine (Tina) Murray, AHRQ (Project Officer)  Christine Williams, AHRQ  Glen Bennett, NHLBI  Stephen Heishman, NIDA  Corrine Husten, CDC  Glen Morgan, NCI

PHS 9 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

PHS 10 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

PHS 11 Peer Review/Public Comment  Over 90 independent tobacco treatment experts served as peer reviewers  Federal Register notice announced availability of guideline for public comment

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

PHS 13 Combinations: Medication and Counseling Effectiveness of and estimated abstinence rates for the combination of counseling and medication versus medication alone (n = 18 studies) Treatment Number of arms Estimated odds ratio (95% C.I.) Estimated abstinence rate (95% C.I.) Medication alone Medication and counseling (1.2, 1.6) 27.6 (25.0, 30.3)

PHS 14 Combinations: Medication and Counseling Effectiveness of and estimated abstinence rates for the combination of counseling and medication versus counseling alone (n = 9 studies) Treatment Number of arms Estimated odds ratio (95% C.I.) Estimated abstinence rate (95% C.I.) Counseling alone Medication and counseling (1.3, 2.1) 22.1 (18.1, 26.8)

PHS 15 TreatmentRecommendations Treatment Recommendations –Counseling – Counseling 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).

PHS 16 Strength of Evidence for Recommendations ClassificationCriteria Strength of Evidence = A Multiple well-designed randomized clinical trials, directly relevant to the recommendation, yielded a consistent pattern of findings. Strength of Evidence = B Some evidence from randomized clinical trials supported the recommendation, but the scientific support was not optimal. For instance, few randomized trials existed, the trials that did exist were somewhat inconsistent, or the trials were not directly relevant to the recommendation. Strength of Evidence = C Reserved for important clinical situations where the panel achieved consensus on the recommendation in the absence of relevant randomized controlled trials.

PHS 17 Pro-Active Quitlines Effectiveness of and estimated abstinence rates for quitline counseling compared to minimal interventions, self-help or no counseling (n = 9 studies) Intervention Number of arms Estimated odds ratio (95% C.I.) Estimated abstinence rate (95% C.I.) Minimal or no counseling or self-help Quitline counseling (1.4, 1.8) 12.7 (11.3, 14.2)

PHS 18 Effectiveness of and estimated abstinence rates for quitline counseling and medication compared to medication alone (n = 6 studies) Intervention Number of arms Estimated odds ratio (95% C.I.) Estimated abstinence rate (95% C.I.) Medication alone Medication and quitline counseling (1.1, 1.6) 28.1 (24.5, 32.0) Pro-Active Quitlines

PHS 19 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

PHS 20 Varenicline Effectiveness and abstinence rates for various medications and medication combinations compared to placebo at 6- months post-quit (n = 86 studies) Medication Number of arms Estimated odds ratio (95% C. I.) Estimated abstinence rate (95% C. I.) Placebo Varenicline (2 mg/day) (2.5, 3.8) 33.2 (28.9, 37.8)

PHS 21 Nicotine Lozenge Lozenge Dose N for active/ N for placebo Odds Ratio (95% C.I.) Continuous abstinence rates at 6 months (Active/Placebo) 2 mg459/ (1.4, 2.8) 24.2/ mg450/ (1.9, 4.0) 23.6/10.2 Effectiveness of the nicotine lozenge: Results from the single randomized controlled trial.

PHS 22 Relative Efficacy Medication Number of arms Estimated odds ratio (95% C. I.) Nicotine Patch (reference group) Varenicline (2 mg/day)5 1.6 (1.3, 2.0) Patch (long-term; >14 weeks) + NRT (gum or spray) (1.3, 2.7) Patch + Bupropion SR3 1.3 (1.0, 1.8)

PHS 23 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)

PHS 24 Specific Populations  Children and Adolescent Smokers  Light Smokers  Noncigarette Tobacco Users  Pregnant Smokers

PHS 25 Special Populations  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

PHS 26 Low Socio-Economic Status/Limited Formal Education Intervention Number of arms Estimated odds ratio (95% C. I.) Estimated abstinence rate (95% C. I.) Usual care or no counseling Counseling (1.0,1.9) 17.7 (13.7, 22.6) Effectiveness of and estimated abstinence rates for counseling interventions with low socio-economic status/limited formal education (n = 5 studies)

PHS 27 Psychiatric Disorders Including Substance Use Disorders Intervention Number of arms Estimated odds ratio (95% C. I.) Estimated abstinence rate (95% C. I.) Placebo Bupropion SR or nortryptyline (1.7, 6.8) 29.9 (17.5, 46.1) Effectiveness of and estimated abstinence rates for treatment with bupropion and nortryptyline for smokers with a history of depression (n = 4 studies)

PHS 28 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).

PHS 29 Adolescent Smokers Effectiveness of and estimated abstinence rates for counseling interventions with adolescent smokers (n = 7 studies) Adolescent smokers Number of arms Estimated odds ratio (95% C.I.) Estimated abstinence rate (95% C.I.) Usual care Counseling7 1.8 (1.1, 3.0) 11.6 (7.5, 17.5)

PHS 30 Adolescent Smokers 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)

PHS 31 Pregnant Smokers Effectiveness of and estimated pre-parturition abstinence rates for psychosocial interventions with pregnant smokers (n = 8 studies) Pregnant smokers Number of arms Estimated odds ratio (95% C.I.) Estimated abstinence rate (95% C.I.) Usual care Psychosocial intervention (abstinence pre-parturition) (1.4, 2.3) 13.3 (9.0, 19.4)

PHS 32 Pregnant Smokers 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)

PHS 33 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

PHS 34 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) Treatment Number of arms Estimated odds ratio (95% C.I.) Estimated quit attempt rate (95% C.I.) Individuals with no covered benefit Individuals with the benefit (1.01, 1.5) 36.2 (32.3, 40.2)

PHS 35 Intervention as a Covered Health Benefit Estimated abstinence rates for individuals who received tobacco use interventions as a covered benefit (n = 3 studies) Treatment Number of arms Estimated odds ratio (95% C.I.) Estimated abstinence rate (95% C.I.) Individuals with no covered benefit Individuals with the benefit (1.2, 2.2) 10.5 (8.1, 13.5)

PHS 36 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).

PHS 37 Systems Interventions: Clinician Training and Chart Reminders Effectiveness of clinician training combined with charting on asking about smoking status (“Ask”) (n = 3 studies) Intervention Number of arms Odds Ratio (95% C.I.) Estimated rate (95% C.I.) No intervention Training and charting (1.9, 2.4) 75.2 (72.7, 77.6)

PHS 38 Systems Interventions: Clinician Training and Chart Reminders Effectiveness of training combined with charting on setting a quit date (“Assist”) (n = 2 studies) Intervention Number of arms Odds Ratio (95% C.I.) Estimated rate (95% C.I.) No intervention Training and charting (4.1, 7.4) 41.4 (34.4, 48.8)

PHS 39 Systems Interventions: Clinician Training and Chart Reminders Effectiveness of training combined with charting on arranging for follow-up (“Arrange”) (n = 2 studies) Intervention Number of arms Odds Ratio (95% C.I.) Estimated rate (95% C.I.) No intervention Training and charting (1.9, 3.9) 16.3 (11.8, 22.1)

PHS 40 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).

PHS 41 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). For Smokers Not Willing To Make a Quit Attempt at This Time

PHS 42 Ask Ask about tobacco use. Identify and document tobacco use status for every patient at every visit. Advise Advise to quit. In a clear, strong and personalized manner urge every tobacco user to quit. Assess Assess willingness to make a quit attempt. Is the tobacco user willing to make a quit attempt at this time? Assist Assist in quit attempt. For the patient willing to make a quit attempt, use counseling or pharmacotherapy to help him or her quit. Arrange Arrange followup. Schedule followup contact, preferably within the first week after the quit date. The "5 A's" Model for Treating Tobacco Use and Dependence

PHS 43 Ask Ask about tobacco use. Identify and document tobacco use status for every patient at every visit. Advise Advise to quit. In a clear, strong and personalized manner urge every tobacco user to quit. Assess Assess willingness to make a quit attempt. Is the tobacco user willing to make a quit attempt at this time? Assist For patients unwilling to quit at the time, provide interventions designed to increase future quit attempts. 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 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

PHS 44 The "5 A's" Model for Treating Tobacco Use and Dependence

PHS Key Guideline Recommendations

PHS 46 1.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. 2.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

PHS 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

PHS 48  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

PHS 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: Bupropion SRNicotine nasal spray Nicotine gumNicotine patch Nicotine inhalerVarenicline Nicotine lozenge  Clinicians should also consider the use of certain combinations of medications identified as effective in this Guideline.

PHS 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. 10 Key Guideline Recommendations

PHS If a tobacco user is currently unwilling to make a quit attempt, clinicians should use the motivational treatments shown in this Guideline to be effective in increasing future quit attempts. 10. Tobacco dependence treatments are both clinically effective and highly cost-effective relative to interventions for other clinical disorders. Providing coverage for these treatments increases quit rates. Insurers and purchasers should ensure that all insurance plans include the counseling and medication identified as effective in this Guideline as covered benefits. 10 Key Guideline Recommendations

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

PHS 53 Key Guideline Web Links  Guideline Materialshttp://  List of over 55 endorsing organizations at update2008_endorse.htm  May 7 th Webcasthttp:// then click on View the Webcast  UW-CTRIwww.ctri.wisc.edu