What s new in tobacco cessation

1. What�s new in tobacco cessation Lynne J. Goebel, MD, FACP Professor Internal Medicine Joan C. Edwards School of Medicine Marshall University

2. Tobacco Cessation Provider Training Thanks to a grant from the WV Department of Health and Human Resources Division of Tobacco Prevention

3. Study Pre and post lecture questions 3 month brief follow up survey � mail or email link to anonymous survey Evaluation forms for CE credit

4. What is your age? 20-30 31-40 41-50 51-60 61 or more

5. What is your gender? Male Female

6. What is your profession? Physician Dentist Dental hygienist Nurse practitioner /physician assistant Nurse Other

7. How often do you recommend pharmacotherapy to your patients trying to quit tobacco use? Very frequently Frequently Average A little Not at all

8. ObjectivesBy the end of this presentation you will be able to: Recall the tobacco cessation guidelines Counsel your patients using motivational interviewing techniques Recommend pharmacotherapy for tobacco cessation Recall procedures for reimbursement for tobacco cessation counseling

9. Guidelines: the 5 A�s Ask- every visit Advise � clear and personalized Assess �Ready to quit in next 30 days? Assist � Counsel/Handouts/Drugs Arrange- follow up

10. Guidelines - Modified Ask Advise Refer to quitline

11. Counseling

12. Stages of Behavioral Change Precontemplation Contemplation Preparation Action Relapse Maintenance Termination

13. Stage of Change Precontemplation = Says �I�m taking them to the grave� Not willing to �hear� risks Often labeled �hopeless case�

14. How do you counsel a patient in the precontemplation stage? Advise him in a clear and personalized manner to quit. Argue that smoking is causing his problems even if he denies it. Avoid talking about it since it only aggravates the patient. Tell him that he may get cancer if he doesn�t quit.

15. Counseling Strategy for Precontemplation Stage Advise to quit in a clear and personalized manner Give a supportive statement, �Let me know when you are ready to quit and I will help you.� Give an empowering statement: �Only you can decide when it�s right for you to quit.�

16. Precontemplation counseling Motivational interviewing - a way to have a conversation about the problem behavior that may lead the patient to make a change (increases patient�s likelihood of making a future quit attempt.) EX. Decision analysis

18. Contemplation Stage of Change Says, �I know I should quit, but it�s just not the right time.� Considering changing in the next 6 months Often labeled as procrastinators

19. Motivational Interviewing Use your OARS Open ended questions � �What concerns you about your smoking?� �What do you think would be the hardest part of quitting?�

20. OARS Affirm � recognize the patient�s strengths � �It�s great that you were able to quit for a few months. You were able to make it through the worst withdrawal symptoms.�

21. OARS cont�d Reflect � Restate what the patient said, 3:1 ratio (3 patient reflections to one provider comment). �So you use smoking as something to do when you are bored.. . .� Comment �I have some suggestions, would you like to hear them?�

22. OARS Summarize your reflections: �Let me see if I have this correct. . .You know you need to quit but you are too stressed to make a quit attempt right now. . .� and then: �What�s the next step?� �Do you see yourself making any changes in the next month?� (Change smoking pattern.) Create a change plan if pt. is ready.

24. Motivational Interviewing tips for success Express empathy (�It must be hard for you to quit when your spouse smokes too.�) Develop discrepancy (�It sounds like you are very devoted to your children. Have you thought about how your smoking affects your children?�) Roll with Resistance � back off and redirect � go for the money! Let the decision to change come from the patient

26. Contemplation 45 year old male s/p recent MI. He knows he needs to quit. Last time he tried he gained 20 lbs. He scored 6/10 for ready, 10/10 important, 5/10 successful. He says that if it wasn�t for the gain in weight he would be ready to try again.

27. What is the best counseling strategy regarding weight gain and smoking cessation? All of the smoking cessation drugs cause weight gain so avoid these. Weight gain is only 30 pounds on average. Go on a strict diet at the same time you quit smoking to avoid weight gain. Exercise can help counteract weight gain and does not affect success at smoking cessation.

28. Video example

29. Modified Guidelines Ask Advise Refer (to Quitline if ready to set quit date)

30. Resources State Quitline 1-877-966-8784 (1 877 Y NOT QUIT) Free nicotine replacement �gum, patches, lozenges for most WV residents 2-4 telephone counseling sessions with a trained cessation counselor http://ynotquit.workbetter.net/

31. WV QUITLINE Since 2000, enrolled over 43,000 people or 11% of the state�s smokers Average 1 yr quit rate 25.3% Expanded hours 8AM-9PM M-F and 8AM-5PM Sat and Sun New fax referral

32. Pharmacotherapy for Tobacco Cessation Nicotine replacement Non-nicotine medication Bupropion (Zyban, Wellbutrin SR) Varenicline (Chantix)

33. Nicotine Replacement Nicotine gum � OTC Nicotine patch �OTC Nicotine nasal spray � Rx Nicotine Inhaler � Rx Nicotine Lozenge � OTC Of the current pharmacotherapies available as aids for smoking cessation, the first approved by the FDA were nicotine replacement therapies (NRT). There are 5 forms NRT now available in the United States: Nicotine gum (2mg) which was approved by the FDA for prescription in 1984, the 4mg dose was approved in 1992 and became available over the counter (OTC) in 1996. The nicotine patch was approved in 1991 and became available OTC in 1996. The nicotine nasal spray was approved in 1996, the nicotine inhaler in 1997, and the nicotine lozenge was approved as OTC in 2003. In 1997, Bupropion SR received an indication as an aid to smoking cessation. It has been nearly a decade since approval of a new prescription pharmacotherapy as an aid for smoking cessation. Of the current pharmacotherapies available as aids for smoking cessation, the first approved by the FDA were nicotine replacement therapies (NRT). There are 5 forms NRT now available in the United States: Nicotine gum (2mg) which was approved by the FDA for prescription in 1984, the 4mg dose was approved in 1992 and became available over the counter (OTC) in 1996. The nicotine patch was approved in 1991 and became available OTC in 1996. The nicotine nasal spray was approved in 1996, the nicotine inhaler in 1997, and the nicotine lozenge was approved as OTC in 2003. In 1997, Bupropion SR received an indication as an aid to smoking cessation. It has been nearly a decade since approval of a new prescription pharmacotherapy as an aid for smoking cessation.

34. Nicotine gum: Not used properly. Chew and park. Avoid acidic beverages. Nicotine nasal spray: Burns your nose. ?addiction potential in 15-20% Nicotine inhaler: Looks funny. Transdermal patch preferred treatment option. 8 weeks of treatment max. 4/2/2 One year success rate 20 - 30%.

35. Nicotine replacement Safe in patients with heart disease, but not in first two weeks after MI, unstable angina or serious arrhythmias If insomnia, remove patch before bed or use the 16 hour patch Combining patch with gum/lozenge/spray may increase success rate

36. NEW: Pre-cessation NRT One study used patches 2 wks prior to quitting and then 12 wks after, increase in abstinence at 6 months Another study increased abstinence at 4 weeks but not at 6 months Conflicting results

37. NEW: Use of NRT to decrease smoking Gum, inhaler or patch or a combination of these in patients not ready to quit Use of NRT to cut down smoking resulted in twice as many smokers being abstinent at 12 months � but only 8.4% abstinence rate (OR 2.5 CI 1.7-3.7) Needs more research

38. Bupropion SR Antidepressant Increases dopamine � reward pathway Start at 150 SR daily for three days then increase to twice daily if tolerated Quit smoking after 1-2 weeks on drug Treat for 2 - 6 months or longer

39. Bupropion: Summary DISADVANTAGES Contraindications: seizure disorder, anorexia nervosa, MAO inhibitor use. Caution: Cytochrome P450 drugs, alcohol or benzodiazepine use, hepatic disease, HTN Advantages of bupropion SR include the following: Bupropion SR is an oral formulation (twice-a-day dosing) that is easy to use. Bupropion SR might be beneficial for use in patients with coexisting depression. There is no risk of nicotine toxicity if the patient continues to smoke. Disadvantages of bupropion SR include the following: The seizure risk is increased. Several contraindications and precautions preclude use.Advantages of bupropion SR include the following: Bupropion SR is an oral formulation (twice-a-day dosing) that is easy to use. Bupropion SR might be beneficial for use in patients with coexisting depression. There is no risk of nicotine toxicity if the patient continues to smoke. Disadvantages of bupropion SR include the following: The seizure risk is increased. Several contraindications and precautions preclude use.

40. Bupropion side effects Insomnia (35%) and dry mouth (10%) most common If insomnia, cut back to just daytime dose or take the PM dose earlier but at least 8 hours after the AM dose

41. Varenicline Brand name Chantix Partial agonist to receptor in the brain that controls release of dopamine (reward system)

42. This in vivo study in rats demonstrates that varenicline functions as a nicotinic acetylcholine receptor partial agonist. Measurement of extracellular dopamine levels over a 6-hour time course was measured in conscious rats (in vivo) in order to assess partial agonist activity. Microdialysis studies with nicotine and varenicline measuring in vivo dopamine release in rat nucleus accumbens confirmed the partial agonist effect. At a maximally effective dose of 1 mg/kg po, varenicline produced a sustained increase in dopamine release to 60% of the maximal nicotine effect. In addition, 1 mg/kg po varenicline reduced the dopamine-enhancing effects of a subsequent dose of nicotine to that of varenicline alone. Varenicline functions as an ?4?2 nicotinic acetylcholine receptor partial agonist. Varenicline was deliberately designed for the ?4?2 receptor, as a partial agonist (with inherent dual agonist and antagonist properties). Varenicline binds to and partially stimulates the ?4?2 receptor without creating a full nicotinic effect on the production of dopamine. In the presence of nicotine, varenicline blocks the receptor, preventing nicotine from binding, and thereby attenuating nicotine�s effect.This in vivo study in rats demonstrates that varenicline functions as a nicotinic acetylcholine receptor partial agonist. Measurement of extracellular dopamine levels over a 6-hour time course was measured in conscious rats (in vivo) in order to assess partial agonist activity. Microdialysis studies with nicotine and varenicline measuring in vivo dopamine release in rat nucleus accumbens confirmed the partial agonist effect. At a maximally effective dose of 1 mg/kg po, varenicline produced a sustained increase in dopamine release to 60% of the maximal nicotine effect. In addition, 1 mg/kg po varenicline reduced the dopamine-enhancing effects of a subsequent dose of nicotine to that of varenicline alone. Varenicline functions as an ?4?2 nicotinic acetylcholine receptor partial agonist. Varenicline was deliberately designed for the ?4?2 receptor, as a partial agonist (with inherent dual agonist and antagonist properties). Varenicline binds to and partially stimulates the ?4?2 receptor without creating a full nicotinic effect on the production of dopamine. In the presence of nicotine, varenicline blocks the receptor, preventing nicotine from binding, and thereby attenuating nicotine�s effect.

43. Start pills 1 week before quit date. Chantix Starter Pak Chantix Continuation Pak: 1 mg twice a day Dosing: Renal Impairment: CrCl 30 mL/minute: No adjustment required CrCl <30 mL/minute: Initiate: 0.5 mg once daily; maximum dose: 0.5 mg twice daily Hemodialysis: Maximum dose: 0.5 mg once daily

44. Varenicline: Summary DISADVANTAGES May induce nausea in up to one third of patients. Post-marketing surveillance suggestive of suicidal ideation. Advantages of varenicline include the following: Varenicline is an oral formulation (twice-a-day dosing) that is easy to use. Varenicline offers a new mechanism of action for persons who previously failed using other medications. Disadvantages of varenicline include the following: The drug may induce nausea in up to one third of patients. Post-marketing surveillance data not yet available.Advantages of varenicline include the following: Varenicline is an oral formulation (twice-a-day dosing) that is easy to use. Varenicline offers a new mechanism of action for persons who previously failed using other medications. Disadvantages of varenicline include the following: The drug may induce nausea in up to one third of patients. Post-marketing surveillance data not yet available.

45. Chantix (varenicline) If nausea cut dose in half for a week and then try to increase again. If patient successful during the first 12 weeks, may continue for another 12 weeks for highest success rate.

46. Special Populations Pregnant women Adolescents Smokeless tobacco users

47. Maternal Smoking in WV In 2005, 26.6% of mothers smoked during pregnancy Low birth weight higher among smokers 15% compared to non smokers 7.6% Preterm births higher among smokers 14.1% compared to non smokers 11.9%

48. Stats on WV babies Infant mortality/SIDS rate higher - 11.1 per 1000 live births among smokers compared to 6.8 for non smokers

49. Pregnant women Nicotine patch (Wisborg et al, 2000) 250 smokers, placebo controlled trial Used 15 mg patch (16 hr) then 10 mg patch No significant difference in quit rates on patch Higher birthweight on patch Smaller study patch (Kapur et al, 2001) 38% stayed off smoking until after delivery-short term benefit?

50. Pregnant women 181 women randomized to NRT plus counseling vs. counseling � stopped early due to increase in adverse events in NRT group (preterm labor) 30% vs. 17%

51. Pregnant Women Bupropion � 2 prospective studies ongoing, Class B/C Worldwide pregnancy registry � Glaxo Data on 333 pregnancy outcomes No significant difference in birth defects but numbers too small at this time Don�t use if pre-eclampsia � seizure risk

52. Pregnant women Varenicline � Class C, no studies Bottom line � no drugs effective in pregnant women at this time so use counseling alone. Some OB�s use bupropion or gum/lozenge if patient unable to quit by second visit.

53. Adolescents RCT Nicotine patch or gum or placebo Trial 120 participants, 53 completed Compliance better for patch (80%) than gum (40%) Quit rates at 3 months 18% patch, 6.5% gum (NS), 2.5% placebo

54. Adolescents Another study showed 20% quit rate with patch compared to 18% placebo NS Patch plus bupropion 8% vs. Patch plus placebo 7% 6 month quit rates.** Bottom line � not enough info on adolescents at this time.

55. What treatments improve long term abstinence rates for smokeless tobacco users? Nicotine patch Nicotine gum Bupropion Varenicline None of the above

56. Adult Smokeless Tobacco Users Nicotine replacement doesn�t help with abstinence (2 patch studies, 1 gum), but helps withdrawal symptoms

57. Smokeless tobacco Bupropion increases short term abstinence in 2 pilot studies (doubles the rate at 3 months compared to placebo) but long term data in recent trial showed no difference in abstinence but decreased craving and weight gain No studies with varenicline

58. Who currently pays the provider for tobacco cessation counseling? Aetna Blue cross Medicare US Healthcare

59. How to bill Use these codes in addition to usual E and M code 99406 3-10 minutes counseling 99407 greater than 10 minutes counseling Use tobacco use ICD-9 code 305.1

60. How much does it pay?Medicare $12. for 3-10 minutes $24. for more than 10 minutes

61. Documentation Document the 5 A�s State how much time was spent in counseling for tobacco use

63. Summary Guidelines - 5 A�s of smoking cessation or Ask advise and refer to the quitline Motivational interviewing � OARS, Decision Analysis, Ready Willing and Able Use medication in most patients Not enough is known about Pregnant women, adolescents and smokeless users Get reimbursed by Medicare

64. How do you counsel a patient in the precontemplation stage? Advise him in a clear and personalized manner to quit. Argue that smoking is causing his problems even if he denies it. Avoid talking about it since it only aggravates the patient. Tell him that he may get cancer if he doesn�t quit.

65. What is the best counseling strategy regarding weight gain and smoking cessation? All of the smoking cessation drugs cause weight gain so avoid these. Weight gain is only 30 pounds on average. Go on a strict diet at the same time you quit smoking to avoid weight gain. Exercise can help counteract weight gain and does not affect success at smoking cessation.

66. What treatments improve long term abstinence rates for smokeless tobacco users? Nicotine patch Nicotine gum Bupropion Varenicline None of the above

67. Who currently pays the provider for tobacco cessation counseling? Aetna Blue cross Medicare US Healthcare