Pharmacotherapy for Nicotine Dependence
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1 Pharmacotherapy for Nicotine Dependence David McFadden, MD, MPH Timothy J. Milbrandt, MS, TTS 2013 MFMER slide-1
2 Disclosures Dr. McFadden has participated in Pfizersponsored tobacco treatment seminars in Mexico, Brazil, and Chile Tim Milbrandt has no disclosures Will be discussing off label usage of medications 2013 MFMER slide-2
3 Outline Introduction of seven FDA approved medications Combination protocols Case studies 2013 MFMER slide-3
4 Question Which of these Nicotine Replacement medications both require prescriptions? A. Nicotine lozenges and Nicotine Inhaler B. Nicotine patch and Nicotine Nasal spray C. Nicotine inhaler and Nicotine nasal spray D. Nicotine inhaler and Nicotine lozenges 2013 MFMER slide-4
5 FDA approved medications Five NRT (Nicotine based medications) Nicotine gum (OTC) Nicotine patch(otc) Nicotine lozenges (OTC) Nicotine inhaler Nicotine nasal spray Bupropion Varenicline 2013 MFMER slide-5
6 NRT Nicotine Gum 2 mg and 4 mg. Select dose based on estimated addiction level or cpd (cigarettes per day) 4 mg. Smoked first AM cigarette < 30 min. upon arising Or smokes > 20 cpd Educate patient chew and park technique 2013 MFMER slide-6
7 Question Which form of NRT has the fastest absorption? A. Nicotine inhaler B. Nicotine lozenge C. Nicotine nasal spray D. Nicotine gum 2013 MFMER slide-7
8 NRT-nasal spray Has fastest absorption rate of any NRT Unpopular due to nasal mucosal irritation Initial intolerance, but eventual acceptance Requires prescription 2013 MFMER slide-8
9 NRT --lozenges 2mg and 4 mg --dosage similar to gum Mini lozenges preferred by most Faster and more complete absorption than gum Technique important Educate patient --lozenge parked against buccal mucosa Do NOT swallow Few patients note hiccups 2013 MFMER slide-9
10 NRT --patch Dosage calculated on cpd (1 mg./1 cpd) Example smokes 40 cpd Rx. Nicotine patch 42 mg. (two 21 mg. patches) Often underdosed and then patient believes not effective Often discontinued prematurely (should be used for minimum of 12 weeks) 2013 MFMER slide-10
11 NRT inhaler Popular among smokers (hand to mouth action) Only available by prescription Technique is important take frequent shallow puffs; not deep inhalations as with respiratory inhalers. Absorption is through buccal mucosa; not lungs 2013 MFMER slide-11
12 Bupropion Antidepressant Interacts with many medications including MAO inhibitors and SSRIs Contraindicated in patients with seizure disorder or prior head injury resulting in loss of consciousness 2013 MFMER slide-12
13 Varenicline Newest medication 2006 Effective in patients with CVD and COPD Side effects Nausea Unusual dreams (sometimes pleasant) Possible psychiatric issues NOT cardiovascular disease 2013 MFMER slide-13
14 Combinations NRT short acting (NG, NL, NNS, NI) with maintenance (Nicotine patch) NRT with Bupropion (start Bupropion 1 week before quit date; NRT on quit date NRT with Varenicline (start Var 1 week before quit date; NRT on quit date) Bupropion with Varenicline (start both 1 week before quit date) 2013 MFMER slide-14
15 Varenicline/Buproprion combination Pilot study at Mayo Chanban study (phase 2 study) Results: 58% quit rate at 6 months (cf 44% quit rate 3 months with Varenicline alone) Reference: Ebbert, J.; Nicotine and Tobacco Research (3): ; Feb. 25, currently larger study in progress Mayo/ Univ. MN MFMER slide-15
16 NRT Label changes FDA has determined the safety of NRT and proposed the following label changes: 1. Omit the do not use statement if you continue to smoke 2. begin using NRT on your quit date even if you are still smoking 3. If you feel the need to use NRT longer than the specified period (12 weeks), discuss with your health care provider Ref: FDA consumer Health information (April, 2013) MFMER slide-16
17 Case Study #1 48 year old female Hospitalized w/opioid & Benzodiazepine abuse Has quit smoking successfully using Bupropion twice and would like to use it again Has suffered a seizure in the interim Reasons to quit - smoking is not, nor has it ever been a good fit for her 2013 MFMER slide-17
18 Case Study #1 Reports smoking 20 cigarettes per day Currently using a 14 mg patch which is providing some relief Continues to experience some cravings 2013 MFMER slide-18
19 Case Study #1 What would you advise? A - Stop the nicotine patch and start her on Varenicline B - Continue on 14 mg patch and advise her that the cravings should eventually subside C - Increase her patch dose to 21 mg and offer intermittent NRT such as the nicotine inhaler, for breakthrough cravings D - Start her on Bupropion as she has had good luck with that in the past 2013 MFMER slide-19
20 Case Study #2 32 year old male who chews two tins of smokeless tobacco daily Quit chewing for 11 months using Bupropion, 42 mg patch, and 2 mg gum Stopped using patch because he felt like he was getting too much nicotine Stopped Bupropion because he didn t think it was helping Increased his nicotine gum use to 20 pieces daily 2013 MFMER slide-20
21 Case Study #2 Used 20 pieces of gum daily for 11 months Stopped using gum with concerns about his length of use Shortly thereafter he relapsed to using chewing tobacco due to nicotine withdrawal He returns and expresses a desire to be tobacco free 2013 MFMER slide-21
22 Case Study #2 What do you do first? A - Provide him with prescriptions for Bupropion, 42 mg patch, and gum again B - Suggest that he try Varenicline since the other pharmacotherapy plan did not work C - Offer him 4 mg nicotine gum since that is what worked best for him. (Lozenges are an option as well) D - Congratulate him on his 11 month quit and his continued desire to be tobacco free 2013 MFMER slide-22
23 Case Study #3 61 year old male in St. Mary s Hospital following myocardial infarction Smokes 50 cigarettes per day He is pleasantly surprised at how comfortable he is using 35 mg patch After discussing 42 mg patch plus ad lib NRT as a common dose for a 40 cigarette per day smoker patient states a preference to remain on 35 mg patch and add 2 mg mini-lozenge 2013 MFMER slide-23
24 Case Study #3 As the TTS what do you suggest? A Try to convince him to use a higher patch dose B Try to convince him to use Varenicline or Bupropion to supplement his patch and lozenge C Congratulate him on his decision to use 35 mg patch and mini-lozenges, and encourage him to call if he develops strong cravings or withdrawals D Tell him if he isn t going to use the right medication dose he might as well not use any 2013 MFMER slide-24
25 Case Study #4 32 year old male who was smoking cigarettes per day He tried using 21 mg nicotine patch but it fell off so stopped after 3 days and started smoking Uses nicotine inhaler intermittently In the past month has reduced to 5 cpd As the TTS what are your next steps? 2013 MFMER slide-25
26 Case Study #4 A Assess patient s interest in trying patches again and suggest medical tape to secure them and use in combination with inhaler as needed B Congratulate him on decreasing to 5 cpd and revisit and strengthen patient s motivation to quit smoking C Explore potential obstacles to the medication plan and problem-solve them in collaboration with the patient D - All of the above 2013 MFMER slide-26
27 Case Study #5 8 day Residential Patient 50 year old male in alcohol recovery for several years with chronic pain Smoked cpd Day 1 21 mg patch, Varenicline 0.5 mg once daily, 2 mg gum Day 3 Serum cotinine 438 (from day 1 prior to medications), many withdrawals and cravings to smoke 2013 MFMER slide-27
28 Case Study #5-8 day Residential Patient NEXT STEPS? A Add Bupropion B Increase Varenicline to 1.0 BID C Continue 21 mg patch D Increase patch to 42 mg 2013 MFMER slide-28
29 Questions? 2013 MFMER slide-29
30 Case Study #5-8 day Residential Patient Increased to 42 mg patch, Varenicline 0.5 mg BID, and add nicotine gum. Day 6 Serum cotinine 494 using 42 mg patch, gum, Varenicline 0.5 mg am, 1.0 mg pm. Urges and cravings minimal Day 8 Varenicline 1.0 BID, 42 mg patch, gum At 21 days smoke-free patient was dizzy and reduced to 21 mg patch and felt better. Continued on Varenicline 1.0 BID, 2 mg gum 2013 MFMER slide-30
31 Case Study #5 - Residential Patient-- phone follow up At 25 days smoke-free Patient felt nauseated so reduced Varenicline to 0.5 BID and increased to 42 mg patch 35 days smoke-free Patient nauseated and ill, stopped Varenicline, continues on 42 mg patch, gum 3.5 months after quit date patient reports that he relapsed after six weeks and is now smoking cigarettes per day. He set a new quit date and plans to use Varenicline 0.5 mg BID, 21 mg patch, and 2 mg lozenge 2013 MFMER slide-31
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