1. A SSOCIATION FOR M EDICAL E DUCATION AND R ESEARCH IN S UBSTANCE A BUSE E-Cigarette Use among Smokers with Serious Mental Illness J UDITH J. P ROCHASKA, P H D, MPH A SSOCIATE P ROFESSOR OF M EDICINE S TANFORD U NIVERSITY

2. Financial Disclosures: Principal Investigator on Federal and State research awards: NHLBI R01, NIMH R01, NIDA P50 Component, TRDRP Pilot CARA Ad hoc consultant with Pfizer Expert witness in litigation against tobacco companies

3. SMOKING PREVALENCE by PSYCHIATRIC DIAGNOSIS National Comorbidity Survey 1991-1992 Source: Lasser et al., 2000 JAMA 41.0% Overall Active

4. SMOKING & MENTAL ILLNESS: PREVALENCE over TIME % Current Smokers National Comorbidity Survey, Lasser et al. JAMA 2000 National Survey of American Life, Hickman et al. NTR 2010 Healthcare for Communities survey Ong et al. AJPH 2010 1991-1992 2000-2001 2001-2003 2009-2011 CDC Vital Signs MMWR, 2012

5. SMOKING by MH STATUS: NY STATE, 2000-01 and 2008-09 NY State Report 2012

6. SMOKING in PSYCHIATRY: ADULTS in SAN FRANCISCO, CA Acton, Prochaska, Kaplan, Small & Hall. (2001) Addict Behav Benowitz, Schultz, Haller, et al. (2010) Am J Epi Prochaska, Gill, & Hall. (2004) Psychiatric Services Cigarettes/day M(SD) 21 (15) 17 (12) 15

7. MAJOR TARGET MARKET  Estimates that 44% to 46% of cigarettes consumed in US by smokers with psychiatric or addictive disorders (Lasser, 2000; Grant, 2002)  175 billion cigarettes and $39 billion in annual tobacco sales (USDA, 2004)

8. Project SCUM 1995-1997  RJ Reynolds’ SubCulture Urban Marketing Campaign for  Gay people in the Castro and “street people” in the Tenderloin  Noted the high incidence of smoking and drugs in these subcultures  Plan was to introduce Camel cigarettes into less traditional retail outlets, like "head shops”  Eventually changed the campaign to Project Sourdough

9. WHAT ABOUT E-CIGARETTES? (vape pens, e-hookahs, hookah pens)  Cigarette-shaped device consisting of a battery and a cartridge containing an atomizer to heat a solution, often with nicotine By January 2014 there were 466 brands (each with its own website) and 7764 unique flavors (Zhu, 2014)

10.  Use rising rapidly: 1% (2009) to 6% (2011) of US adults  Majority of EC users current or former smokers  Dual use is common  Attraction of EC:  Use in settings with smoking bans  Perceptions may aid cessation  Perceived healthier alternative to traditional cigarettes  Projections: EC will eclipse conventional cigarettes in 10 yrs E-CIGARETTES Pepper & Brewer (2013); Herzog et al. (2013)

11. RCT of EC for CESSATION  RCT: 16 mg nicotine EC, non-nicotine EC, 21 mg patch  657 smokers interested in quitting  13% using antidepressants or anxiolytics  Verified 6-mo prolonged abstinence:  7% nicotine EC, 6% patch, 4% placebo EC  Minimal counseling; only a third attended a session  Adherence greater for EC (78%) than patches (46%)  EC users liked their tactile, cigarette-like qualities, sensory familiarity, taste, perceived health benefits, ease of use, and absence of cigarette odor Bullen et al. (2013) Lancet

12. E-CIGS & SCHIZOPHRENIA  1 study of EC in smokers with SMI, uncontrolled study  14 smokers w/ schizophrenia not intending to quit  Wk 52:  50% (7/14) reduced cigarettes/day by > 50%  14% (2/14) were smoke-free  1 to 2 cartridges/day used throughout the study  Schizophrenia symptoms did not increase with smoking reduction/cessation Caponnetto et al. 2013 Enviro Res Public Health

13. ECs for JAILS/PRISONS Young-Wolff, Karan, & Prochaska (in press). JAMA Psychiatry

14. PAIRED with ALCOHOL USE

15. “Giving psychiatric patients access to e-cigarettes, particularly on closed wards, is definitely something to consider."

16.  N=10,041  US population survey in Feb 2012 E-CIGs & MENTAL HEALTH Cummins et al. (2014) Tobacco Control Tried EC Current EC Future EC

17.  N=956, 50% men  Mean age = 39 (SD=14)  21% employed  Race/ethnicity:  15% were Hispanic  57% Caucasian  24% African American  5% Asian/Pacific Islander  14% multiracial/other STAR STUDY 2009 - ongoing

18.  Mean = 17 (SD=10) cigarettes per day  Mean = 19 (SD=14) years  78.5% smoked within 30 minutes of waking  Stage of change for quitting smoking: TOBACCO USE PC = Precontemplation C = Contemplation P = Preparation

19. 3-6 months of nicotine patch plus gum/lozenge

20. N=956 randomized Usual Care N=134 Brief Tx N=414 3 mo 90% retention 6 mo 90% retention 12 mo 86% retention 18 mo 87% retention Extended Tx N=408 Study Flow-Chart

21. E-CIG USE: SMOKERS with SERIOUS MENTAL ILLNESS (N=956) Growth in Reported E-cig Use by Year of Study Enrollment Prochaska & Grana (in press) PLOS ONE

22.  Later year of enrollment: OR=29.2 (95% CI 10.5 - 80.7)  Younger age (18-25): OR =2.6 (1.2 - 5.7)  nonHispanic vs. Hispanic: OR=4.0 (1.8 - 8.9)  Preparation vs. precontemplation: OR=2.7 (1.4 - 5.2) PREDICTORS of E-CIG USE NS: gender, race, employment status, hospital site, study condition, psychiatric or substance use diagnosis, mental health severity, time to 1 st AM cig, cigs/day Prochaska & Grana (in press) PLOS ONE

23.  Abstinence at latest FU available:  21% for EC users and 19% for non-EC users, p=.726  Among continued smokers:  >50% reduction in cigarettes/day (cpd)  EC (51%) vs. non-EC users (51%), p=.978  Median reduction in cpd: 7.1 (EC) vs. 6.6 (non-EC), p=.730  CPD at latest FU: 10.0 (EC) vs. 10.1 (non-EC), p=.915  All smoking outcomes NS by EC use in adjusted models E-CIG USE and SMOKING (N=956) Prochaska & Grana (in press) PLOS ONE

24.  Smokers with SMI increasingly tried EC, particularly young adults (age 18-25) and non-Hispanics  Smokers preparing to quit had >2-fold greater likelihood of EC use  EC use during the prospective trial was unrelated to abstinence status nor, among those who did not quit, reduction in smoking  A few participants reported encouragement to use EC by their clinicians DISCUSSION

25.  Limited to 3 hospitals in the SF Bay Area  EC use was not directly assessed  likely under-detected use  Did not assess duration or continued EC use STUDY LIMITATIONS Findings underscore the need for inclusion of smokers with mental health concerns in studies of e-cigarette use for smoking cessation and harm reduction.

26. CONTACT INFORMATION: Email: JPro@Stanford.edu Ph: 650-724-3608 Website: rxforchange.ucsf.edu "This product is not a smoking cessation product and has not been tested as such. This product is intended for use by persons of legal age or older, and not by children, women who are pregnant or breast feeding, or persons with or at risk of heart disease, high blood pressure, diabetes, or taking medicine for depression or asthma. Nicotine is addictive and habit forming, and it is very toxic by inhalation, in contact with the skin, or if swallowed. Nicotine can increase your heart rate and blood pressure and cause dizziness, nausea, and stomach pain. Inhalation of this product may aggravate existing respiratory conditions. Ingestion of the non- vaporized concentrated ingredients in the cartridges can be poisonous.” Big Tobacco New EC Warning Label: