Tobacco Dependence Treatment From Neurobiology through Public Policy Mary Ellen Wewers, PhD, MPH, RN Professor Emerita The Ohio State University College of Public Health Disclosures Funding from the National Institutes of Health National Cancer Institute P50CA180908 R21CA205589 P003398602 Mary Ellen Wewers, PhD, MPH, RN 1
Objectives: To describe prevalence of tobacco use among patients with mental illness. To characterize a new theory about the neurobiology of nicotine addiction. To describe evidence-based clinical interventions for tobacco dependence treatment for patients/clients with mental illness. To discuss policy level tobacco control interventions for implementation in health care settings and communities. Background information: Smoking prevalence among those with mental illness Mary Ellen Wewers, PhD, MPH, RN 2
Adult Smoking Prevalence CDC 2013 50 Mental Illness* Male 40 Mental Illness* Female % 30 20 U.S. 10 0 *Diagnosed mental, behavioral or emotional disorder Excludes developmental or substance abuse disorder Smoking & Mental Illness: By poverty level CDC 2013 60 50 % 40 30 20 10 0 At or above Below Mary Ellen Wewers, PhD, MPH, RN 3
Smoking and Mental Illness: By age CDC 2013 50 40 % 30 20 10 0 18 24 25 44 45 64 65+ Smoking and Mental Illness: By education CDC 2013 50 40 % 30 20 10 0 Less than HS HS grad Some college College graduate Mary Ellen Wewers, PhD, MPH, RN 4
Smoking and Mental Illness: By race/ethnicity CDC 2013 % Smoking and Mental Illness: By region CDC 2013 50 40 % 30 20 Midwest South Northeast West 10 0 Mary Ellen Wewers, PhD, MPH, RN 5
Smoking prevalence by psychiatric diagnosis Lasser et al. 2000 90 80 70 % 60 50 40 30 20 10 Bipolar Disorder Gen Anxiety Disorder Schizophrenia Major Depression 0 None History Active Active Smoking and schizophrenia Meta-analysis of 42 studies on tobacco smoking among schizophrenia patients found an average smoking prevalence of 62% (range 14-88%) Citation bias Studies reporting higher prevalence were more commonly cited in the research literature Trend was also apparent on the Internet Chapman et al. 2009 Mary Ellen Wewers, PhD, MPH, RN 6
Smoking and Mental Illness: Over time NHSDA2000-01; NSDUH 2004-11 50 40 % 30 20 10 Serious psychological distress No serious psychological distress 0 2001 2004 2005 2008 2009 2011 Neurobiology of Nicotine Addiction Mary Ellen Wewers, PhD, MPH, RN 7
Neurobiology of Nicotine Addiction Neurochemical and related effects of nicotine Nicotine Dopamine Norepinephrine Acetylcholine Glutamate Serotonin β-endorphin GABA Pleasure & Appetite suppression Arousal & Appetite suppression Arousal & Cognitive enhancement Learning & Memory enhancement Reduced anxiety & Reduced tension Mood modulation & Appetite suppression Benowitz 2008 Mary Ellen Wewers, PhD, MPH, RN 8
Stages of Addiction Volkow et al. 2016 Stage Binge & intoxication Shifting drivers resulting from neuroadaptation Feeling euphoric Feeling good Escaping dysphoria Withdrawal & negative affect Feeling reduced energy Feeling reduced excitement Feeling depressed, anxious, restless Preoccupation & anticipation Looking forward Desiring drug Obsessing and planning to get drug Transition from experimentation to addiction: a function of progressive neuroadaptation Voluntary Action Abstinence Constrained use Behavioral Changes Sometimes: taking when not intended having trouble stopping taking more than intended Impulsive action Relapse Compulsive use Mary Ellen Wewers, PhD, MPH, RN 9
Neurobiology of Addiction Volkow et al. 2016 Addiction is an acquired brain disease Onset starts in adolescence Developing brain is sensitive to drug-induced neuroplasticity Nicotine exposure leads to changes in synaptic signaling between neurons and reward regions of brain Prevention is key during adolescence Adult brain requires behavioral and pharmacological treatment Mary Ellen Wewers, PhD, MPH, RN 10
Clinical Interventions for Tobacco Dependence Treatment The Health Impact Pyramid Thomas Friedan, 2010 Increasing Population Impact Increasing Individual Effort Needed Counseling and Education Clinical Interventions Tobacco dependence treatment Long-lasting Protective Interventions Tobacco 21, Banning ads to youth Changing the Context to Make Healthy Default Decisions Smoke-free laws, Tobacco tax Socioeconomic Factors Poverty, education, employment Mary Ellen Wewers, PhD, MPH, RN 11
Just as Ready to Quit Smoking Acton 2001;Prochaska 2004,2006; Nahvi 2006 % Treating Tobacco Use and Dependence: 2008 Update U.S. Public Health Service All patients should be Screened for tobacco use Advised to quit Offered treatment All patients should be offered pharmacological treatment, unless contraindicated There is a dose-response relationship between intensity of treatment and abstinence Endorsed by APNA Mary Ellen Wewers, PhD, MPH, RN 12
Available First-line Pharmacotherapies US PHS 2008 Long term ( 6 month) quit rates % Mary Ellen Wewers, PhD, MPH, RN 13
Varenicline in Smokers with Depression Anthenelli et al. 2013 % abstinent 525 adults with stably treated or past depression Significant treatment effects at all time points (p.001) Non-significant difference in suicidal ideation Most frequent AE: Nausea (27%) 2 deaths in Varenicline group (during non-tx phase) Varenicline in Smokers with Schizophrenia Williams et al. 2012 % abstinent 127 stable outpatient adults Significant treatment effects at both time points (p.001) No evidence of symptom exacerbation Varenicline was well tolerated Mary Ellen Wewers, PhD, MPH, RN 14
Varenicline for Relapse Prevention: Smokers with Schizophrenia and Bipolar Disorder Evins et al. 2014 % abstinent 87 participants who were continuously abstinent (CA) at week 12 Randomized to CBT and varenicline or placebo from weeks 12-52 Followed to week 76 Significant treatment effects at all time points (p.001) Meta-analyses for bupropion among persons with schizophrenia Tsoi et al. 2010 Banham et al. 2010 Six randomized clinical trials 260 participants End of treatment abstinence OR = 2.57 (95% CI 1.35-4.88) 6 month abstinence OR = 2.78 (95% CI 1.02-7.58) Conclusion: Bupropion was found to be well tolerated in patients with schizophrenia who are stabilized on an adequate antipsychotic regime Mary Ellen Wewers, PhD, MPH, RN 15
FDA Boxed Warning For patients with serious neuropsychiatric symptoms Patients should be advised to stop taking varenicline or bupropion and to contact a health-care provider immediately if they experience agitation, depressed mood, and any changes in behavior that are not typical of nicotine withdrawal, or if they experience suicidal thoughts or behavior Cochrane Network Meta-Analysis: Serious Adverse Events (SAE) Cahill et al. 2013 21 Bupropion studies (n=7859) Event rate for any SAE 2.5% drug vs. 2.2% placebo Neuropsychiatric event rate 0.8% drug vs. 0.9% placebo No excess of neuropsychiatric events 14 Varenicline trials (n=6333) Event rate for any SAE 2.1% drug vs. 2.0% placebo Neuropsychiatric event rate 0.15% drug vs. 0.21% placebo No excess of neuropsychiatric events Mary Ellen Wewers, PhD, MPH, RN 16
Meta-analysis: Varenicline & Neuropsychiatric AE Thomas et al. 2015 39 Trials (n=10,761 participants) Relative to placebo No increased risk of Suicide or attempted suicide (OR=1.67, 0.22-8.57) Suicidal ideation (OR=0.58, 0.28-1.21) Depression (OR=0.96, 0.75-1.22) Aggression (OR=0.91, 0.52-1.59) Increased risk of Sleep disorders (OR=1.63, 1.29-2.07) Insomnia (OR=1.56, 1.36-1.78) Abnormal dreams (OR=2.39, 2.05-2.77) Fatigue (OR=1.28, 1.06-1.55) Decreased risk of anxiety (OR=0.75, 0.61-0.93) Behavioral Counseling Cognitive behavioral therapy (CBT) in combination with pharmacotherapy significantly improves treatment outcomes Individual counseling = group counseling Proactive telephone counseling is efficacious USPHS Clinical Practice Guideline 2008 Quit line counseling not tailored to those with mental illness 25% of California Quitline callers met criteria for current major depression Hebert et al. 2011 Mary Ellen Wewers, PhD, MPH, RN 17
Specialized Telephone Counseling for Mental Health Clinic Patients Rogers et al. 2016 Percent abstinent at 6 mo * OR=1.62, 1.24-2.11 Conducted in VA Health System in NE U.S. 577 Mental Health clinic patients referred for treatment by HCP Specialized telephone counseling regarding mental health issues vs. referral to state quit line Mailed medications to both groups Policy Approaches Mary Ellen Wewers, PhD, MPH, RN 18
The Health Impact Pyramid Thomas Friedan, 2010 Increasing Population Impact Increasing Individual Effort Needed Counseling and Education Clinical Interventions Tobacco dependence treatment Long-lasting Protective Interventions Tobacco 21, Banning ads to youth Changing the Context to Make Healthy Default Decisions Smoke-free laws, Tobacco tax Socioeconomic Factors Poverty, education, employment Tobacco Control Best Practices Comprehensive smoke-free laws High tobacco taxes/prices Funding for tobacco control programming Counter-marketing Treatment for nicotine addiction Surveillance Support for local coalitions Mary Ellen Wewers, PhD, MPH, RN 19
Smoke Free Environments NASMHPD 2005-2011 % Impact of Cigarette Price Increases on U.S. Cigarette Sales 1969-2009 TCLC/CPHSS 2014 Mary Ellen Wewers, PhD, MPH, RN 20
Smokers with a mental health diagnosis are price sensitive Ong et al. 2010 For every 10% increase in the price of cigarettes Treatment for Nicotine Addiction Offer tobacco dependence treatment 25% of mental health centers 42% of substance abuse treatment centers SAMHSA 2010, 2013 Affordable Care Act Mental Health Parity and Addiction Equity Act Mary Ellen Wewers, PhD, MPH, RN 21
Medicaid Coverage for Tobacco Dependence Treatments in Massachusetts and Associated Decreases in Smoking Behavioral Counseling + Pharmacotherapy Land et al. 2010 The Health Impact Pyramid Thomas Friedan, 2010 Increasing Population Impact Increasing Individual Effort Needed Counseling and Education Clinical Interventions Tobacco dependence treatment Long-lasting Protective Interventions Tobacco 21, Banning ads to youth Changing the Context to Make Healthy Default Decisions Smoke-free laws, Tobacco tax Socioeconomic Factors Poverty, education, employment Mary Ellen Wewers, PhD, MPH, RN 22
Adolescents and Prevention What s next Regulating tobacco product ingredients Flat minimum price of $10.50 per pack New York City Tobacco 21 Institute of Medicine Recommendations ~ 80 municipalities and State of Hawaii Mary Ellen Wewers, PhD, MPH, RN 23
Conclusions Prevalence of smoking is significantly higher among those with a mental illness Smokers with a mental health diagnosis want to quit smoking Tobacco control involves a comprehensive, multilevel approach Clinical interventions are effective Policy level approaches enhance individual level treatment Mary Ellen Wewers, PhD, MPH, RN 24