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(1)

Pharmacotherapy for Nicotine

Dependence

David McFadden, MD, MPH Timothy J. Milbrandt, MS, TTS

(2)

Disclosures

• Dr. McFadden has participated in Pfizer-sponsored tobacco treatment seminars in Mexico, Brazil, and Chile

• Tim Milbrandt has no disclosures

• Will be discussing off label usage of medications

(3)

Outline

• Introduction of seven FDA approved medications

• Combination protocols

(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

(5)

FDA approved medications

• Five NRT (Nicotine based medications)

• Nicotine gum (OTC)

• Nicotine patch(OTC)

• Nicotine lozenges (OTC)

• Nicotine inhaler

• Nicotine nasal spray

• Bupropion

(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

(7)

Question

• Which form of NRT has the fastest absorption?

• A. Nicotine inhaler

• B. Nicotine lozenge

• C. Nicotine nasal spray

(8)

NRT-nasal spray

• Has fastest absorption rate of any NRT

• Unpopular due to nasal mucosal irritation

• Initial intolerance, but eventual acceptance

(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

(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)

(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

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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

(13)

Varenicline

• Newest medication –2006

• Effective in patients with CVD and COPD

• Side effects

• Nausea

• Unusual dreams (sometimes pleasant)

• Possible psychiatric issues

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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)

(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 2009 11(3):234-239; Feb. 25, 2009

(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)

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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

(18)

Case Study #1

• Reports smoking 20 cigarettes per day

• Currently using a 14 mg patch which is providing some relief

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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

(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

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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

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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)

(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

(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

(25)

Case Study #4

• 32 year old male who was smoking 15-20 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

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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

(27)

Case Study #5 – 8 day Residential Patient

• 50 year old male in alcohol recovery for several

years with chronic pain

• Smoked 10-20 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

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Case Study #5 - 8 day Residential Patient

• NEXT STEPS?

• A – Add Bupropion

• B – Increase Varenicline to 1.0 BID

• C – Continue 21 mg patch

(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.

(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 10-15 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

References

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