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1 National Behavioral Health Network for Tobacco & Cancer Control:. Community Behavioral Health Organization Community of Practice Prescribing FDA-approved Pharmacotherapy July 12 th, 2016

2 WELCOME! Shelina Foderingham, MPH MSW Project Director Director of Practice Improvement, National Council for Behavioral Health Krystle Canare Project & Logistics Coordinator Project Coordinator, National Council for Behavioral Health

3 Housekeeping Please do the following two steps. Turn off or mute your computer speakers. 2. GoToWebinar INSTRUCTIONS: Join the webinar: Call in using your telephone: +1 (213) Access Code: Audio PIN: Shown after joining the meeting

4 Today s Agenda Welcome & introductions Prescribing FDA-approved pharmacotherapy Q&A Wrap-up & Next Steps

5 Agenda 2:00p Welcome & Introductions 2:15p Prescribing FDA-approved pharmacotherapy 3:15p Q&A 3:25p Next Steps and Wrap Up

6 CBHO Tobacco & Cancer Control CoP Introductions Identify 1 team member to: Introduce yourself and team members on the call AND Name 1 thing you re excited about learning during today s webinar

7 CBHO Tobacco & Cancer Control CoP Adapt Identify 1 team member to: Introduce yourself and team members on the call AND Name 1 thing you re excited about learning during today s webinar

8 CBHO Tobacco & Cancer Control CoP Berks Counseling Center Identify 1 team member to: Introduce yourself and team members on the call AND Name 1 thing you re excited about learning during today s webinar

9 CBHO Tobacco & Cancer Control CoP BlueGrass, Inc. Identify 1 team member to: Introduce yourself and team members on the call AND Name 1 thing you re excited about learning during today s webinar

10 CBHO Tobacco & Cancer Control CoP Institute for Family Health Identify 1 team member to: Introduce yourself and team members on the call AND Name 1 thing you re excited about learning during today s webinar

11 CBHO Tobacco & Cancer Control CoP Johnson County Mental Health Center Identify 1 team member to: Introduce yourself and team members on the call AND Name 1 thing you re excited about learning during today s webinar

12 CBHO Tobacco & Cancer Control CoP Northwest Alabama Mental Health Center Identify 1 team member to: Introduce yourself and team members on the call AND Name 1 thing you re excited about learning during today s webinar

13 CBHO Tobacco & Cancer Control CoP Pacific Clinics Identify 1 team member to: Introduce yourself and team members on the call AND Name 1 thing you re excited about learning during today s webinar

14 CBHO Tobacco & Cancer Control CoP The Center for Counseling & Consultation, Health Wellness Identify 1 team member to: Introduce yourself and team members on the call AND Name 1 thing you re excited about learning during today s webinar

15 CBHO Tobacco & Cancer Control CoP United Services, Inc. Identify 1 team member to: Introduce yourself and team members on the call AND Name 1 thing you re excited about learning during today s webinar

16 CBHO Tobacco & Cancer Control CoP West Texas Centers Identify 1 team member to: Introduce yourself and team members on the call AND Name 1 thing you re excited about learning during today s webinar

17 Today s Presenter Christine Garver-Apgar, MD Research Associate Behavioral Health & Wellness Program Christine.Garver-apgar@ucdenver.edu

18 DIMENSIONS: Tobacco Pharmacotherapy

19 Objectives Describe the biology of tobacco dependence Describe the symptoms and duration of nicotine withdrawal Provide information on: All approved tobacco dependence medications Combination therapy Special considerations for specific groups

20 Evidence-Based Tobacco Cessation The U.S. Department of Health & Human Services - Public Health Service Clinical Guideline: Treating Tobacco Use and Dependence Update Counseling and medication are effective when used by themselves for treating tobacco dependence. The combination of counseling and medication, however, is more effective than either alone.

21 Tobacco Dependence Has Two Parts Tobacco dependence is a 2-part problem Physical The addiction to nicotine Treatment Behavior The habit of using tobacco Treatment Medications for cessation Behavior change program Treatment should address both the addiction and the habit. Courtesy of the University of California, San Francisco

22 The Biology of Tobacco Dependence

23 Nicotine differs from other drugs of abuse since a greater percentage of those who try it become daily users than those who try other drugs.

24 Tobacco Use Cycle Tobacco Product Used Craving Nicotine Absorption Withdrawal Symptoms Arousal, Mood Modulation, Pleasure Tolerance

25 Tobacco Smoke Delivery and Absorption Cigarettes can readily deliver approximately 1-2 mg of nicotine Reaches the brain within 10 seconds after inhalation 90% of nicotine is absorbed through inhaled or mainstream smoke directly from a cigarette rather than second-hand or sidestream smoke

26 Prefrontal cortex Dopamine Reward Pathway Dopamine release Stimulation of nicotine receptors Nucleus accumbens Ventral tegmental area Nicotine enters brain

27 Neurochemical Effects of Nicotine Dopamine Norepinephrine Acetylcholine Glutamate -Endorphin GABA Serotonin Pleasure, reward Arousal, appetite suppression Arousal, cognitive enhancement Learning, memory enhancement Reduction of anxiety and tension Reduction of anxiety and tension Mood modulation, appetite suppressant

28 Other Effects of Nicotine

29 Initial Effects of Nicotine Initial experience with smoking can cause nausea, dizziness, and/or coughing in some individuals It can also cause pleasurable experiences in others (e.g., head rush, buzz, dizziness) Aversive effects diminish quickly with repeated tobacco use

30 Nicotine Withdrawal Effects Irritability, frustration, anger Anxiety Difficulty concentrating Restlessness, impatience Depressed mood Insomnia Increased appetite Most symptoms: Appear within the first 1 2 days Peak within the first week Decrease within 2 4 weeks

31 Nicotine Addiction Cycle

32 Regulating Nicotine Intake Wide variability in the amount of nicotine absorbed The typical smoker will take 10 puffs per cigarette This equals 200 hits of nicotine to the brain each day for a pack-a-day habit Smokers consciously and unconsciously regulate nicotine intake

33 Nicotine Metabolism Most nicotine is metabolized by the liver by an enzyme called cytochrome P450 5% - 10% of nicotine is excreted via urine, unchanged The half-life of nicotine in the blood is ~ 120 minutes

34 Cessation Pharmacotherapy

35 Why Use a Medication for Quitting? Medications: Make people more comfortable while quitting by reducing withdrawal symptoms Allow people to focus on changing their behavior Improve chances of a successful quit attempt

36 Tobacco Cessation Medications The only medications approved by the Food and Drug Administration (FDA) for tobacco cessation are: Nicotine gum Nicotine lozenge Nicotine patch Nicotine nasal spray Nicotine inhaler Bupropion SR tablets Varenicline tablets

37 Safety of NRT No known interactions with most psychiatric meds. Safe in presence of cardiovascular disease Effective for patients with chronic obstructive pulmonary disorder (COPD) Safe while individual is still smoking General precautions: Within 2 weeks of a heart attack Serious arrhythmia Uncontrolled hypertension Peptic ulcers Insulin-dependent diabetes Severe or worsening angina

38 Nicotine is absorbed through the skin Sold without a prescription Do not cut in half Apply a new patch every 24 hours Nicotine Patch

39 NRT Patch Dosages and Application NicoDerm CQ (OTC) Patch strength Duration 21 mg/day 6-8 weeks 14 mg/day 2-4 weeks 7 mg/day 2-4 weeks Generic (OTC) Possible side effects: local skin reaction, insomnia

40 Patch Application: Tips for Clients Peel off ½ of the adhesive backing Apply adhesive exposed side to skin Peel off remaining backing Press firmly with palm of hand for 10 seconds Make sure patch is firmly adhered to skin Do not cut the patch in half Carefully dispose of patch after removing

41 Sugar-free chewing gum Nicotine Gum Available in different flavors Absorbed through the lining of the mouth Available in two strengths Sold without a prescription May not be a good choice for people with jaw problems, braces, retainers, or significant dental work

42 Nicotine Gum Dosages Scheduled dosing increases success with this treatment <20 cigarettes per day 2 mg gum every 1-2 hours >20 cigarettes per day or smoke within 30 minutes of waking up 4 mg gum every 1-2 hours Slowly taper dosing as tolerated over 8 to 12 weeks No less than 9 doses and no more that 24 doses per day

43 Gum: Directions for Use Chew each piece slowly until the gum releases a peppery taste or slight tingling. Park the gum between cheek and gum to allow for absorption across the buccal mucosa Resume chewing when taste or tingle fades When tingle returns, stop chewing and park gum in a different place in mouth Repeat process until the tingle is gone (about 30 minutes)

44 Sugar-free lozenge Nicotine Lozenge Available in different flavors Absorbed through the lining of the mouth Available in two strengths Sold without a prescription Use 1 lozenge every 1 to 2 hours Possible side effects are mouth/ throat soreness or indigestion

45 Nicotine Nasal Spray About 100 doses per bottle Quickly absorbed through the lining of the nose Sold with a prescription as Nicotrol NS

46 Nicotine Inhaler Absorbed through the lining of the mouth Allows for similar handto-mouth ritual of smoking Sold with a prescription Possible side effects are throat/mouth irritation, coughing, and runny nose

47 Label Update: Nicotine Replacement Therapy Drug Facts Labeling Previous Label Warnings Do not use. If you continue to smoke, chew tobacco, use snuff, or use a different NRT product or other nicotine-containing products. Directions Stop smoking completely when you begin using the NRT product. It is important to complete treatment. Stop using the NRT product at the end of a specified number of weeks. If you still feel the need to use the NRT product, talk to you doctor. Drug Facts Labeling Current Label Warnings None. The Do not use statement has been removed. Directions Begin using the NRT product on your quit day. It is important to complete treatment. If you feel you need to use the NRT product for a longer period to keep from smoking, talk to you healthcare provider.

48 Bupropion SR Tablets Does not contain nicotine The tablet is swallowed whole, and the medication is released over time Sold with a prescription as Zyban or generic Initial dose of 150 mg/day for 3 days, followed by 150 mg twice daily for 6-12 weeks

49 Bupropion Side Effects and Precautions Side effects include: Insomnia (35-40%) Dry mouth (<10%) Agitation, decreased appetite, dizziness, headache, nausea Avoid recommending to individuals: With eating disorders At increased risk for seizures Diagnosed with bipolar disorder With concomitant or recent use (past 2 weeks) of MAO inhibitors Take precautions for individuals with schizophrenia

50 Varenicline Does not contain nicotine The tablet is swallowed whole Sold with a prescription only as Chantix People who take Chantix should be in regular contact with their doctor Initial dosing is 0.5 mg/day for 3 days and then twice daily for 4 days. For next 11 weeks, dosing is 1 mg twice daily

51 Varenicline Side Effects and Precautions Side effects include: Nausea Headache Insomnia and abnormal dreams Constipation and flatulence Precautions for individuals: Operating heavy machinery With kidney or cardiac problems Taking insulin, asthma medications, or blood thinners

52 Pharmacotherapy Efficacy Abstinence rates compared to placebo at 6 months or greater post-quit Medication Number of Trials (People) Estimated Risk Ratio NRT 117 (51,265) 1.6 ( ) Bupropion 44 (13,728) 1.6 ( ) Varenicline 14 (6,166) 2.3 ( )

53 NRT Efficacy Abstinence rates compared to placebo at 6 months or greater post-quit Medication Number of Studies (People) Estimated Risk Ratio Patch 43 (19,586) 1.6 ( ) Gum 56 (22,581) 1.5 ( ) Lozenge 7 (3,405) 2.0 ( ) Inhaler 4 (976) 1.9 ( ) Nasal Spray 4 (887) 2.0 ( ) 2016 BHWP

54 Percent quit Long-Term (36-month) Quit Rates for Cessation Medications

55 Combination Therapy Use of two or more forms of tobacco cessation medications can improve cessation rates PLUS OR OR OR PLUS PLUS OR

56 Abstinence rates compared to single medication at 6 months or greater post-quit Medication Number of Studies (People) Estimated Risk Ratio Patch + Other NRT vs. Patch only Patch + Bupropion Vs. Bupropion only 9 (4,664) 1.34 ( ) 4 (1,991) 1.2 ( )

57 Pre-Cessation Nicotine Replacement Studies show individuals who used NRT before their quit date: Did not experience any significant side effects Experienced an increase in their quit rates Were twice as likely to maintain their abstinence at 6 months

58 Considerations for Specific Groups

59 Women, Pregnancy and Nursing Mothers NRT is not as effective with women Women may need more intensive behavioral and pharmacological support Pregnant/nursing mothers Pharmacotherapy should only be considered when behavioral treatments fail Treatment must be monitored by a physician Although NRT exposes woman to nicotine, it does NOT expose her to the other harmful chemicals in tobacco

60 Youth NRT is a consideration for youth who are clearly nicotine dependent Use is off-label Must present a clear desire to quit Evidence and recommendations are mixed

61 Cessation Medications for Persons with Mental Illnesses and Addictions Higher levels of nicotine dependence There is no medical reason not to use cessation medications First line treatments are recommended for all Comfortable detox for temporary abstinence Recent trials of varenicline for schizophrenia and depression Effective No greater side effects

62 ANTIPSYCHOTICS ANTIDEPRESSANTS MOOD STABLIZERS ANXIOLYTICS OTHERS Medications Known or Suspected To Have Their Levels Affected by Smoking and Smoking Cessation Chlorpromazine (Thorazine) Clozapine (Clozaril) Fluphenazine (Permitil) Haloperidol (Haldol) Mesoridazine (Serentil) Amitriptyline (Elavil) Clomipramine (Anafranil) Desipramine (Norpramin) Doxepin (Sinequan) Duloxetine (Cymbalta) Carbamazepine (Tegretol) Alprazolam (Xanax) Diazepam (Valium) Acetaminophen Caffeine Heparin Insulin Rasagiline (Azilect) Olanzapine (Zyprexa) Thiothixene (Navane) Trifluoperazine (Stelazine) Ziprasidone (Geodon) Fluvoxamine (Luvox) Imipramine (Tofranil) Mirtazapine (Remeron) Nortriptyline (Pamelor) Trazodone (Desyrel) Lorazepam (Ativan) Oxazepam (Serax) Riluzole (Rilutek) Ropinirole (Requip) Tacrine Warfarin

63 Everyone who uses tobacco should be offered an opportunity to make the decision to stop.

64 DIMENSIONS: Tobacco Free Toolkits for Healthcare Providers *supplements for other priority populations and Spanishtranslations are also available

65 Behavioral Health & Wellness Program Behavioral Health and Wellness Program BHWP_UCD

66 Comments & Questions?

67 Upcoming Dates Aug.2 nd, 3p-5pET: Webinar #2: Sustainability & Scalability of Tobacco-Free Policies for Outpatient, Inpatient, and Residential Treatment Facilities Register Here:

68 Thank you! Questions? Contact Krystle Canare at

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