My Mask. I keep it all inside. Because I d rather. The pain destroy me. Than everyone else. Anon.

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1 My Mask KL I keep it all inside Because I d rather The pain destroy me Than everyone else. Anon. 43

2 K. N. Roy Chengappa, M.D., FRCPC Professor of Psychiatry, University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic, Chief, Comprehensive Service Line Disclosures Grant Support for Smoking Cessation Studies: NIMH and NCATS of the NIH Pfizer, Inc. and Janssen - Drug & Placebo for studies funded by NIH plus materials for IND

3 Tobacco Related Mortality in SMI Patients Hospital discharges of SMI patients linked to death certificates 1990 through 2005 in California, ages 35 years and up 19 diseases linked to tobacco-per CDC Schizophrenia n = 174,277 Deaths n = 44,469 Bipolar Disorder n = 78,739 Deaths n = 12,564 Depressive Disorders n = 338,250 Deaths n = 71,058 53% 48% 50% Tobacco Related Deaths Tobacco Related Deaths Tobacco Related Deaths Callaghan et al. J Psychiatric Res 2014 FDA Approved Smoking Cessation Medications Nicotine Replacement Therapies Transdermal Patch Gum Spray Inhalator Lozenge Bupropion (Zyban) Varenicline (Chantix) Time Lines of FDA Approvals for Smoking Cessation Aids Rx nicotine gum OTC nicotine gum & patch; Rx nicotine nasal spray OTC nicotine lozenge Rx nicotine patch Rx nicotine inhaler; Rx bupropion SR Rx varenicline

4 Nicotine Replacement Therapy Products If you smoke more than 10 cigarettes a day Nicotine Patch STEP 1 21 mg STEP 2 14 mg STEP 3 7 mg Weeks 1-6 Weeks 7-8 Weeks 9-10 If you smoke 10 cigarettes or less a day STEP 2 14 mg STEP 3 7 mg Weeks 1-6 Weeks 7-8

5 Nicotine Patch Wear for 16 hours and take off each night before sleeping Nicotine Gum 2 mg = < 25 cigarettes/day 4 mg = > 25 cigarettes/day Weeks 1-6 Weeks 7-9 Weeks piece Q 1-2 hours 1 piece Q 2-4 hours 1 piece Q 4-8 hours Maximum: 24 pieces/day Chew Slowly, when it tingles/peppery park between gum and cheek. Resume slow chewing when tingling fades. Continue till no tingling or peppery taste (approx. 30 min) Do not swallow like food. Spit it out. No food or beverages 15 minutes before or after. Nicotine Lozenges 2 mg = First cigarette > 30 minutes upon waking 4 mg = First cigarette < 30 minutes upon waking Weeks 1-6 Weeks 7-9 Weeks lozenge Q 1-2 hours 1 lozenge Q 2-4 hours 1 lozenge Q 4-8 hours Maximum: 20 lozenges/day Allow slow dissolution in mouth: 20 minutes (10 minutes for mini ) Do not chew or swallow No food or beverage 15 minutes before or after

6 Nicotine Nasal Spray 0.5 mg nicotine in 50 mcl solution in each spray 1-2 doses per hour 1 dose = one spray in each nostril Maximum: 5 doses/hour, 40 doses/day At least 8 doses/day Don not sniff or swallow Use for 3 to 6 months Nicotine Oral Inhaler 10 mg cartridge Delivers 4 mg nicotine I cartridge q 1-2 hours Cartridge depleted after 20 minutes of active puffing Initial use: 6 cartridges per day No food or beverages 15 min before or after Start with continuous puffs for 20 minutes 3-6 months Bupropion SR 150 mg sustained release 150 mg po q AM x 3 days then 150 mg po BID a)begin therapy 1-2 weeks prior to quit date b)better to avoid nighttime dosing to minimize insomnia c) Often combined with NRT Duration: 3-6 months

7 Varenicline Days 1-3, 0.5 mg po q AM Days 4-7, 0.5 mg po BID Weeks 2-12, 1mg po BID a)begin therapy 1 week before quit date b)take medication after eating and with water Duration: weeks, up to 1 year Long Term ( 6 Months) Quit Rates for Available Cessation Methods Cochrane Database Network Meta-Analysis on Relative Efficacies of Smoking Cessation Aids

8 7-Day Point Prevalence Smoking Abstinence Rates in Stable Patients with Schizophrenia: Buproprion vs Placebo Percentage Abstinence 60% 50% 40% 30% 20% 10% 0% Buproprion Placebo 50% * 18.80% 12.50% 6.30% 10 Weeks (on Rx) Follow-up 6 months (no Rx) * Significant Difference George, T.P. et al. (2002). Biol. Psychiatry 52: Seven-Day Point Prevalence of Abstinence From Cigarette Smoking at Weeks 12 and 24 In Stable Outpatients with Bipolar Disorder 60% Patients % Quit 50% 40% 30% 20% 48.39% 15/31 15/3 1 OR = 8.13 (95% CI, 2.03, 32.53) p = OR = 3.24 (95% CI, 0.60, 17.56) p = % Varenicline Placebo 10% 0% 10.34% 3/29 3/29 6/31 6/31 2/ % 2/29 Week Week (on Rx) Follow-up (no Rx) Chengappa et al, J Clin Psych 2013 Point Prevalence Abstinence during Open, Randomized & Follow-up Phases Stable Patients Mainly Schizophrenia *** ** Evins, Cather, et al., JAMA. 2014

9 EAGLES Study Results: Relative Efficacy of First-Line Smoking Cessation Aids EAGLES Study Results: CARs Weeks 9-12 and 9-24 by Psychiatric History Sub-cohort Neuropsychiatric Side Effects Bupropion had Boxed Warnings for Suicidal ideation and Behavior, and Varenicline for Neuropsychiatric Side Effects. Data from the Eagles Trial resulted in the Boxed Warnings being removed, however Precautions regarding these adverse events remain.

10 EAGLES Results: Neuropsychiatric AEs EAGLES Results: Suicidal Acts and Behavior CYP 1A2 & Drug Clearances & Side-Effects First Point: Polycyclic aromatic hydrocarbons in cigarette smoke NOT nicotine induces the hepatic cytochrome - CYP 1A2 Antipsychotic Drugs: Clozapine, Olanzapine, Haloperidol Anti-depressants: Tricyclics, Fluvoxamine, Duloxetine, Mirtazepine, Trazodone Warfarin, Heparin, Clopidogrel Caffeine (often forgotten)

11 Adverse Effects Patch: irritation, rash, insomnia Gum: jaw soreness, if swallowed: lightheaded, insomnia Lozenge: nausea, heartburn, hiccups, cough, insomnia Oral Inhaler: throat irritation, hiccups, cough, rhinitis Nasal Spray: nasal irritation, rhinitis, tearing, sneezing Bupropion: insomnia, dry mouth, nervousness, rash, seizures (0.1%) Varenicline: nausea, insomnia, vivid dreams Approaches to Smoking Cessation in Persons with Mental Illness Is the person ready to quit? Inpatient Acute vs Outpatient Stable Setting Setting a Quit Date Referrals Specialized Clinics where psychiatrists, pharmacists, therapists, others are schooled in smoking cessation geared to the mentally ill: Counselling, CBT, Motivational Interviewing and Therapy, and Medications to assist Quitting, Managing Nicotine Withdrawal symptoms and urges to smoke Knowledge of psychiatric status, psychiatric and other medications impacted by smoking cessation, and the ability to respond by adjusting medications, and coordinating care with other specialists, etc.

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