1. Tobacco Cessation Interventions Lunch and Learn Seminar Series for Physicians, Family Health Teams, and other Health/Allied Health Practitioners Session 1: Nicotine Replacement Therapy Faculty: Dr. Peter Selby, MBBS, CCFP, MHSc FASAM

2. 2 Housekeeping Please sign-in Please ensure you have completed Learning Assessment 1 http://www.surveymonkey.com/s/fhtapril2011la1 http://www.surveymonkey.com/s/fhtapril2011la1 A link to Learning Assessment 2 will be sent by e-mail Both Learning Assessments are required for the Letter of Completion If you haven’t already, please dial-in via audioconference Conference #: 1-800-669-6180 Participant Code: 925619 The Adobe Connect webinar will remain ON until 1:00 pm

3. Announcement by Minister Best of funding for Family Health Teams to provide free NRT to patients, January 19, 2011 (L-R) Dr. Catherine Zahn, President and CEO of CAMH, Dr. Anne DuVall, President of the Ontario College of Family Physicians; The Honourable Margarett Best, Minister of Health Promotion and Sport; and, Dr. Peter Selby, Clinical Director, Addictions Program and Head of the CAMH Nicotine Dependence Clinic.

4. 4 Dr. Peter Selby, MBBS, CCFP, MHSc FASAM Peter_selby@camh.net (416) 535-8501 ext. 6859 Dr. Peter Selby is the Clinical Director of Addictions Programs and Head of the Nicotine Dependence Clinic at the Centre for Addiction and Mental Health as well as Associate Professor in the Departments of Family and Community Medicine- Dalla Lana School of Public Health-and Psychiatry at the University of Toronto. He is a Principal Investigator at the Ontario Tobacco Research Unit. Some of his areas of research include smoking cessation especially in smokers with co-morbid conditions, and web- based interventions. Dr. Selby is also Principal Investigator of the STOP study, which is investigating the effectiveness of NRT in different types of intervention settings. He is involved in the development of knowledge translation programs in smoking cessation especially in pregnancy and those with concurrent addiction and mental health problems. Dr. Selby is the Executive Director of the TEACH project - a continuing education certificate program in smoking cessation counselling.

5. 5 Dr. Peter Selby Disclosures Dr. Rita Selby Spousal: Sanofi-Aventis, Boehringer Ingelheim, Bayer (Speaker's honorarium, Advisory board) Schering Canada (Buprenorphine training 2000) Johnson & Johnson Consumer Health Care Canada Pfizer Inc. Canada, Pfizer Global Sanofi-Synthelabo Canada GSK Canada Genpharm and Prempharm Canada NABI Pharmaceuticals (Paid consultant and advisory board member) V-CC Systems Inc. and eHealth Behaviour Change Software Co. (Paid consultant) Grants: Health Canada, Smoke Free Ontario, MHP, CTCRI, CIHR Alberta Health Services (formerly Alberta Cancer Board), Vancouver Coastal Authority (Research Funding: Principal & Co-Investigators)

6. 6 The recipient of the funding is in compliance with the CMA and the CPA guidelines / recommendations for interaction with the pharmaceutical industry.

7. 7 These materials (and any other materials provided in connection with this presentation) as well as the verbal presentation and any discussions, set out only general principles and approaches to assessment and treatment pertaining to tobacco cessation interventions, but do not constitute clinical or other advice as to any particular situations and do not replace the need for individualized clinical assessment and treatment plans by health care professionals with knowledge of the specific circumstances. Disclaimer

8. 8 Disclaimer: TEACH Curriculum Development The TEACH Curriculum and slides were developed and compiled with funding from the Government of Ontario, Ministry of Health Promotion. Content of slides are primarily based on evidence based guidelines including: US Guidelines Treating Tobacco Use and Dependence: clinical Practice Guideline 2008 Update. US Department of Health and Human Services, Public Health Service Rethinking Stop-Smoking Medications: Treatment Myths and Medical Realities OMA Position Paper, January 2008. The development or delivery of the TEACH curriculum was not influenced or funded in any part by tobacco industry. TEACH has not received funding from the tobacco industry. The development of the TEACH curriculum has not been influenced by pharmaceutical industry. TEACH project did receive a $10 000 unrestricted grant from Pfizer, to develop video vignettes that are used in our training. Information presented on pharmacotherapy refers to generic products only, and recommendations are based on existing research, including the US guidelines. An algorithm is provided to help practitioners determine if and which pharmacotherapy is appropriate for a smoker.

9. 9 Session 1: Learning Objectives 1. Describe the types of nicotine replacement options 2. Apply evidence-based guidelines in prescribing/recommending nicotine replacement medications 3. Introduce “reduce to quit” as an option for patients who are ambivalent about quitting 4. Apply new knowledge and skills to your practice with your patients

10. 10 # 1 Chronic Disease?

11. 11 Quitting Smoking Unaided: Analysis of 4 Studies Long-term smoking abstinence in those who try to quit unaided = 3%–5% Hughes JR et al. (2004) 3 - 5% Percentage Still Abstinent

12. 12 Immediate Withdrawal Symptoms Cravings to smoke Frustration Anger Anxiety Difficulty concentrating Restlessness Not accounted for by other mental health or physical conditions. Can occur within a few hours of abstinence from nicotine Peak in 1- 4 days Can last up to six months or longer

13. 13 Late-Onset Withdrawal Symptoms Nausea Diarrhea/constipation Shakiness Dizzy (typically more mild) Appetite change Fatigue (can also last up to six months or longer) Sleep disturbances Headaches Clumsiness

14. 14 Medications for Quitting Smoking Medication Nicotine gum Nicotine lozenge Nicotine patch Nicotine inhaler BupropionVarenicline Treatment length 1 - 3 months12 weeks8 - 12 weeks12 - 24 weeks7 - 12 weeks12 -24weeks Main side effects Upset stomach Hiccups Mouth irritation Irregular heartbeat Nausea Heartburn Hiccups Disturbed sleep (insomnia, abnormal/vivi d dreams) Headache Site rash (pruritis erythema, burning) Irritation of throat and nasal passages Sneezing Coughing Dyspepsia insomnia Nausea Dry mouth Nausea Sleep disturbances Constipation Flatulence Dosage 2 mg, 4 mg 5 mg, 10 mg, 15 mg 6 - 12 cartridges per day 150 - 300 mg/day 0.5 mg qd to 1 mg bid Effectiveness at six months or longer† (OR [CI]) 1.66 (1.52 - 1.81) 3.69 * (2.74-4.96) 1.81 (1.63 - 2.02) 2.14 (1.44 - 3.18) 2.06 (1.77 - 2.40) 2.83* (1.91 - 4.19) Adapted from Le Foll & George (2007), Shiffman et al (2002) * 4mg, effectiveness at 6-weeks

15. 15 Nicotine Replacement Therapy (NRT) Provides the body with nicotine to help minimize withdrawal symptoms and cravings Eliminates toxic substances one gets from cigarettes Shown to almost double quit rates Most effective when combined with counselling Can be used to help “reduce” smoking – Can start before quit date

16. 16 Who should use NRT? Not everyone needs NRT Not everyone can afford NRT A behavioural intervention may be more effective for those that smoke 10 cigarettes or less or are non-daily smokers Need to assess case by case – Discuss with client – Use tools to assess dependence

17. Algorithm for Tailoring Pharmacotherapy for Smoking Cessation 1,2 Ask about tobacco use: How much do you smoke? 0 - ___ cigarettes per day (cpd)? (one large pack = 25 cpd, one small pack = 20 cpd) Advise: As your physician, I am concerned about your tobacco use, and advise you to quit. Would you like my help? Yes Motivational Interviewing Assess the 5 R’s: Relevance Rewards Risk Roadblocks Repetition Assess Readiness: Given everything going on in your life, on a scale of 0-10, where 0 is lowest… How important is it for you to quit smoking? How confident are you that you can quit smoking? Low importance or confidence (≤ 5) Assist in Quit Attempt: Would you like to quit abruptly? Reduce to Quit (RTQ) Step 1: (0-6 weeks) - Smoker sets a target for no. of cigarettes per day to cut down and a date to achieve it by (at least 50% recommended) - Smoker uses gum to manage cravings Step 2: (6 weeks up to 6 months) - Smoker continues to cut down cigarettes using gum - Goal should be complete stop by 6 months - Smoker should seek advice from HCP if smoking has not stopped within 9 months Step 3: (within 9 months) - Smoker stops all cigarettes and continues to use gum to relieve cravings Step 4: (within 12 months) - Smoker cuts down the amount of gum used, then stops gum use completely (within 3 months of stopping smoking) Has bupropion/NRT failed? Y Is weight gain a concern?N...History of seizures? N …History of mental illness? N …Eating disorder?N...Allergic to varenicline? N...Previous non-responder? N Want to quit within 7 days? N = Varenicline Has NRT failed?Y/N Is weight gain a concern? Y …History of seizures? N...History of mental illness? N …Eating disorder? N...Allergic to bupropion? N...Previous non-responder? N Want to quit within 7 days? N = Bupropion SR Has bupropion/NRT failed? N Is weight gain a concern? N Want to quit within 7 days? Y = NRT (Gum, Patch, Lozenge or Inhaler) Choose the following combinations: 1. Two or more forms of NRT a. patch (15mg) + gum (2mg) b. patch + inhaler c. patch + lozenge 2. Bupropion + form of NRT a. Bupropion + patch b. Bupropion + gum No Varenicline with NRT Arrange Follow Up 1. Monitor carefully 2. Consider contraindications 3. Consider comorbidities and specific pharmacotherapy 4. Consider dual purpose medications 5. If after 4 weeks no response, consider alternative 1 st line medications.* Consider combination pharmacotherapy, based on: 1. failed attempt with monotherapy 2. breakthrough cravings 3. level of dependence 4. multiple failed attempts 5.experiencing nicotine withdrawal @ 4 weeks Partial response High importance or confidence (>5) No Have you tried quitting cold turkey? Yes: Pharmacotherapy options Cold Turkey No *N.B. for 2 nd line medications (clonidine and nortriptyline), see guidelines. No response YesNo Yes Developed by Peter Selby, MBBS, CCFP. This algorithm is based on: Bader, McDonald, Selby, Tobacco Control, 2009: 18: 34-42. Fiore MC et al., Clinical Practice Guideline: Treating Tobacco Use and Dependence, May 2008. Gray, Therapeutic Choices: 5th Ed., 2007, Chapter 10: 147-157.

18. 18 Nicotine Patch 24 hour continuous dose of nicotine – 21, 14 and 7mg patches (applied every 24h) 16 hour continuous dose of nicotine – 15, 10, and 5 mg (applied every 16h) Off-label use – higher than 21mg dose for highly dependent smokers Potential side effects – May cause sleep disturbance or nightmares Remove before bed – Skin irritation – Clear patch

19. 19 How to Use the Patch Apply to clean dry area above the waist, rotating site daily Remove old patch before applying new one Do not use lotion, moisturizing soap Touch only small corner of adhesive Ensure complete adherence of patch Wash hands in water after application Discard old patch out of reach of children, animals – can be harmful

20. 20 Nicotine Gum Provides body with nicotine for 20-30 minutes 2 & 4 mg doses Responds to the immediate urge to smoke Oral gratification Must be able to chew gum (i.e. no dentures, TMJ) Potential side effects – Upset stomach, hiccups Chewing too fast: review proper use of gum

21. 21 How to Use Nicotine Gum  Chew one piece at a time, no more than 1 per hour  Use every hour – if not in combination with patch  Up to 20 pieces per day as needed 2 mg4 mg Use in combination with patch as a breakthrough medication; typically if smoke <pack/day Use in combination with patch or alone; typically if smoke > pack/day

22. 22 How to Use Gum (2) Chew and park in between teeth and cheeks Absorbed via buccal mucosa Repeat chew every minute or so Each piece lasts approximately 30 minutes Do not chew within 30 minutes of caffeine/acidic products

23. 23 Nicotine Inhaler Small, cigarette-shaped vaporizer Satisfies sensory and ritualistic aspect of smoking One cartridge contains 10mg of nicotine and 1mg menthol Absorbed in oral cavity, throat and upper respiratory tract by “puffing” Potential side effects – throat & mouth irritation, headache, nausea, indigestion(<20%)

24. 24 How to use the Nicotine Inhaler Single cartridge equivalent to 4-5 cigarettes - or 20 minutes of continuous use Puff like cigar, not deeply into the lungs May notice a burning, warm or cool sensation when inhaling – OK unless it becomes bothersome Clean inhaler on a regular basis with soap and water Can use up to 6 cartridges/day – use as needed

25. 25 Nicotine Lozenge 1 mg and 2 mg dosages Max of 15 mg / day should be used Slowly suck until strong taste is noticed Rest lozenge between cheek and gum Wait 1 minute or until taste fades Repeat sucking Each lozenge takes about 30 minutes to consume Use only 1 at a time

26. 26 Reduce to Quit (RTQ) Using NRT Gum Smokers not ready or unable to quit abruptly Shiffman, Ferguson, & Strahs, 2009 WHO GOAL HOW WHEN 50% reduction in daily cigarette consumption between 6 weeks and 4 months of treatment Self-titrate to the level of nicotine to reduce withdrawal symptoms. A reduction of cigarette consumption should be continued until complete cessation can be attempted Craving to smoke in order to prolong smoke- free intervals for as long as possible

27. 27 RTQ Using NRT Gum If such a reduction has not been achieved by 4 months, the patient should be further counselled and/or re-evaluated. A quit attempt should be made as soon as the patient feels ready – but not later than 6 months after the start of treatment. Regular use of the gum beyond 12 months in the Quitting Gradually program is generally not recommended. Shiffman, Ferguson, & Strahs, 2009 HOW LONG Maximum of 20 pieces gum / day HOW MUCH

28. 28 Quitting “Gradually” Comparable to Abrupt Cessation Recent meta-analysis of 3,670 participants and 10 RCT’s indicates similar cessation rates Clients can be given the choice Gradual cessation can be supplemented with behavioural and self-help interventions Linden, Aveyard, & Hughes, 2010

29. 29 Dependence Potential of Nicotine Delivery Devices Dependence potential tends to correlate with time to peak concentration Because the nicotine is delivered differently, more slowly and at lower doses in NRT, it is significantly less addictive then smoking Le Houezec, 2003

30. 30 Dependence Potential of Nicotine Delivery Devices Reaches brain within 15-20 secs for non-daily and less dependent and 30 secs for daily, dependent smokers Gum, lozenge, inhaler peaks in 20 – 30 minutes 1 hr Patch peaks in 2 – 6 hrs 2 hrs 0 Rose et al., 2010

31. 31 Questions?

32. 32 Case Example: Jeanne (1) Jeanne is a 54 year old, divorced female who reports smoking 30-35 cigarettes per day. She began smoking at the age of 14 with her parents in the family home. She was referred to the clinic by her respirologist as she was diagnosed with chronic obstructive pulmonary disease (COPD) 3 months prior. Jeanne lives alone but she smokes in her apartment and in her car. Her friends and family who smoke are allowed to smoke in her home and car. She also smokes at work in a courtyard with her co-workers.

33. 33 Jeanne has tried to quit 3 times in her lifetime. She has tried acupuncture, going "cold turkey" and using the nicotine patch. She reports that none of these strategies really worked for her. Her longest quit attempt was for 7 days, because she was hospitalized. She relapsed within a day of her discharge from the hospital and resumed smoking between 30-35 cigarettes per day immediately. When she doesn't smoke she gets strong cravings, “obsessed with thoughts of smoking,” extremely irritable, anxious and unable to concentrate. Case Example: Jeanne (2)

34. 34 Jeanne reports drinking alcohol socially about once per week, approximately 2-3 glasses of wine per occasion. She reports a history of depression although she is not currently taking any medication or receiving any type of support for this issue. She reports that medication in the past has not made much of a difference. Jeanne has been to hospital emergency rooms twice in the past month because of extreme difficulty breathing. She reports feeling enormous pressure to quit smoking because of her diagnosis of COPD and she reports that she feels ashamed to discuss her smoking with her respirologist. Case Example: Jeanne (3)

35. 35 Jeanne would like to completely quit smoking but she has no set date in mind and she has no idea how to achieve this, because everything she has tried in the past has failed. Ideally, she hopes to have quit completely within 6 months. She rates the importance of quitting smoking at a 10/10 and her confidence level as a 4/10. Case Example: Jeanne (4)

36. 36 Discussion Questions Jeanne states that she has tried the patch in the past and that it did not work for her. 1. Why might this be the case? 2. Does her past experience with the patch rule out NRT as a first option? 3. Given Jeanne’s tobacco use history and level of dependence, what dosage of NRT would you start with? 4. How will you determine optimal dosage and effectiveness of this strategy?

37. 37 For reflection/discussion… What will you take a away from this session? How will your learning impact your clinical practice? What is one thing you will commit to trying with patients in the coming week?

38. Resources

39. 39 Nicotine Does Not Promote Lung Cancer Growth in Mouse Models American Association for Cancer Research

40. 40 CAMH Knowledge Exchange Available at http://knowledgex.camh.net/ A website developed for professionals working in primary care and in the mental health and addictions field, Provides easy-to-access, practical online information and tools Provides primary care providers with the CAMH–St. Joseph’s Health Centre ‘Addictions Toolkit’ which includes links to resources for patients

41. 41 Primary Care ADDICTION TOOLKIT

42. 42 CAN-ADAPTT The Canadian Action Network for the Advancement, Dissemination and Adoption of Practice-informed Tobacco Treatment (CAN-ADAPTT) is a Practice-Based Research Network (PBRN) committed to facilitating research and knowledge exchange among those who are in positions to help smokers make changes to their behaviour (e.g., practitioners, healthcare/service providers) and researchers in the area of smoking cessation. Members will receive: Updates on CAN-ADAPTT’s research and funding opportunities Access to CAN-ADAPTT’s Tobacco Control Guidelines Access to CAN-ADAPTT’s discussion board Notices of General Meetings And may also benefit by: Networking/collaborating with other health care/service providers Exchanging knowledge and expertise of better smoking cessation practices To become a member, simply visit www.can-adaptt.netwww.can-adaptt.net and click "register" to fill out the short registration form found on the home page.

43. 43 Other Resources www.smokershelpline.ca www.dart.on.ca http://Knowledgex.camh.net http://www.samhsa.gov http://www.niaaa.nih.gov Lung Association Reference: 1888 344 LUNG http://www.tobaccocontrol.bmj.com

44. 44 Remember … Online Course Evaluation: http://www.surveymonkey.com/s/fhtapril2011eval http://www.surveymonkey.com/s/fhtapril2011eval Learning Assessment 2: http://www.surveymonkey.com/s/fhtapril2011la2 http://www.surveymonkey.com/s/fhtapril2011la2 This must be completed by April 27th in order to receive your Letter of Completion STOP Study Data Survey: http://www.surveymonkey.com/s/fhtstopdata2 http://www.surveymonkey.com/s/fhtstopdata2 These links will also be sent out by email!! Next session: May 25 th, 2011: Brief Tobacco Screening and Assessment **Application period will be open April 21 st **

45. Thank you!

46. 46 Copyright Copying or distribution of these materials is permitted providing the following is noted on all electronic or print versions: © CAMH/TEACH No modification of these materials can be made without prior written permission of CAMH/TEACH.