Electronic Cigarettes and Smoking Cessation

1. Electronic Cigarettes and Smoking Cessation Sarah Boone, Carolyn Little, Clay Owens, Jeremy Randolph, Genny Tibbs

2. Objectives • Analyze Smoking in Kentucky • List Methods of Smoking Cessation • Acute Effects of Electronic Cigarettes • Review the Evidence of Related Studies • Compare Use of Electronic Cigarettes and Nicotine Patches

3. Smoking in KY http://www.cdc.gov/tobacco/data_statistics/state_data/state_highlights/2010/states/kentucky/

4. Smoking in KY

5. Smoking in KY http://www.cdc.gov/tobacco/data_statistics/state_data/state_highlights/2010/states/kentucky/

6. Smoking Cessation • 80% of smokers who attempt cessation relapse within in first month of quitting • 3-5% remain abstinent at 6 months (Polosa, BMC Public Health, 2011) • Common Methods: • Electronic cigarettes • Nicotine Patches • Oral Medication • “Cold Turkey”

7. Electronic Cigarettes P: Smokers I: Electronic Cigarettes C: Nicotine Patches O: Smoking Cessation Westenberger, FDA, 2009

8. Acute Effects of E-Cigarettes Vansickel, American Association for Cancer Research, 2010

9. Acute Effects of E-Cigarettes • 32 tobacco cigarette smokers • Four products: • Own brand cigarette, “NPRO” electronic cigarettes, “Hydro” electronic cigarettes, or sham • Outcome Measures: • Heart rate, plasma nicotine content, Tiffany Drobes Questionnaire of Smoking Urges Brief Vansickel, American Association for Cancer Research, 2010

10. Acute Effects of E-Cigarettes • Results: • Own brand increased plasma nicotine, CO concentration and heart rate • NPRO EC, Hydro EC, and sham smoking did not • Both EC exposed users to no nicotine or CO • Both EC didn’t increase heart rate • Both EC increased subjective ratings of acceptability Vansickel, American Association for Cancer Research, 2010

11. Acute Effects of E-Cigarettes • Conclusion: • Neither electronic cigarettes exposed users to measurable levels of nicotine or CO • Both suppressed nicotine/tobacco abstinence symptom ratings Vansickel, American Association for Cancer Research, 2010

12. Electronic Cigarettes & Smoking Cessation Polosa, BMC Public Health, 2011

13. Electronic Cigarettes & Smoking Cessation • Methods: • 5 visits: baseline and four follow up visits at week 4, 8, 12, and 24 • Baseline Measurements: • Demographics and detailed smoking history • Level of carbon monoxide in exhaled breath (eCO) • 4 week supply of 7.4 mg nicotine cartridges given • Max use of 4 cartridges/day Polosa, BMC Public Health, 2011

14. Electronic Cigarettes & Smoking Cessation Polosa, BMC Public Health, 2011

15. Electronic Cigarettes & Smoking Cessation • Results: • 50% reduction shown in 13/40 subjects • Combined sustained 50% reduction and smoking abstinence in 22/40 (p≤0.001) • Conclusions: • Reduction in cigarette smoking with e-cigarettes may increase motivation to quit • Gradual reductions in cigarette smoking can increase cessation Polosa, BMC Public Health, 2011

16. Case Series on Smoking Cessation Utilizing E-cigs Caponnetto, Journal of Medical Case Reports, 2011

17. Case Series on Smoking Cessation Utilizing E-cigs • Three chronic smokers (two male, one female) • Severe dependence to nicotine • Fagerstrom Test of Nicotine Dependence (FTND) • Exhaled Breath Carbon Monoxide Concentration (eCO) • Previous cessation efforts (patches & group counseling) Caponnetto, Journal of Medical Case Reports, 2011.

18. Case Series on Smoking Cessation Utilizing E-cigs • Results: • Cessation status following the usage of E-cigs • No relapse 6 months following study • Reduction in eCO • Variation in E-cig composition • Regulation? • Limitation – Small sample size Caponnetto, Journal of Medical Case Reports, 2011.

19. Comparison: Nicotine Patch Therapy Myung et al. 2007, Am J Health-Syst Pharm

20. Comparison: Nicotine Patch Therapy • Study: • Meta-analysis of studies investigating efficacy of nicotine patches vs. placebo. • Purpose: • Assess current literature • Determine an odds ratio for smoking cessation Myung et al. 2007, Am J Health-Syst Pharm

21. Comparison: Nicotine Patch Therapy • Methods: • 16 RCT’s • Total subjects: 9,457 • 6,084 nicotine group • 3,373 placebo group • Results of Meta-analysis: Pooled OR (odds ratio) for 16 studies was 1.79 http://www.nyc.gov/html/doh/html/pr2007/pr036-07.shtml Myung et al. 2007, Am J Health-Syst Pharm

22. Electronic Cigarettes for Smoking Cessation Bullen, Nat Inst Health Innov, 2013

23. Electronic Cigarettes for Smoking Cessation: A Randomized Controlled Trial • Purpose: • To assess whether E-cigarettes containing nicotine were more effective for smoking cessation than nicotine patches • Methods: • 657 subjects were selected for the study • Randomized by computerized block randomization • 4:4:1 ratio Bullen, Nat Inst Health Innov, 2013

24. Electronic Cigarettes for Smoking Cessation: A Randomized Controlled Trial • Procedures: • Subjects used respective smoking cessation products for 12 weeks before a specific “quitting day” • The primary outcome measured was smoking abstinence six months after “quitting day” • Verified by self-report and carbon monoxide measurement Bullen, Nat Inst Health Innov, 2013

25. Electronic Cigarettes for Smoking Cessation: A Randomized Controlled Trial • Results: • Abstinence rates after six months • Nicotine E-cigarette 7.3% • Nicotine Patches 5.8% • Placebo E-cigarette 4.1% • Study was underpowered due to low abstinence rates and could not conclude if E-cigarettes were superior to nicotine patches or placebo Bullen, Nat Inst Health Innov, 2013

26. Summary Smoking Cessation Electronic Cigarettes Nicotine Patch Odds ratio for sustained abstinence after 1 year: 1.79 (compared to placebo) Lowest rates of abstinence after six months • Levels of nicotine or eCO were reduced • Suppressed nicotine/tobacco abstinence symptom ratings • Highest rates of abstinence after six months • Greater success rates with “rituals” of smoking

27. Additional Resources • Stop Smoking Classes Louisville • http://www.louisvilleky.gov/health/iwantto/stopsmokingclasses.htm • Norton Healthcare Smoking Cessation Program • http://www.nortonhealthcare.com/smoking • Kentucky Cabinet for Health & Family Services • http://chfs.ky.gov/dph/mch/hp/tobacco.htm

28. References Bullen C, Howe C, Laugesen M, McRobbie H, Parag V, Williman J, Walker N. Electronic cigarettes for smoking cessation: a randomised controlled trial. Nat Inst Health Innov. 2013; 13:1-9. Caponnetto P, Polosa R, Russo C, Leotta C, Campagna D. Successful smoking cessation with electronic cigarettes in smokers with a documented history of recurring relapses: a case series. Journal of Medical Case Reports. 2011; 5: 585. Myung SK, Yoo KY, Oh SW, et al. Meta-analysis of studies investigating one-year effectiveness of trasdermal nicotine patches for smoking cessation. Am J Health-Syst Pharm.2007; 64: 2471. Polosa R, Caponnetto P, Morjaria JB, Papale G, Campagna D, Russo C. Effect of an electronic nicotine delivery device (e-Cigarette) on smoking reduction and cessation: a prospective 6-month pilot study. BMC Public Health. 2011; 11:786-797. doi:10.1186/1471-2458-11-786. Vansickel AR, Cobb CO, Weaver MF, Eissenberg TE. A clinical laboratory model for evaluating the acute effects of electronic “cigarettes”: nicotine delivery profile and cardiovascular and subjective effects. Amer Assoc Cancer Res. 2010; 19: 1945-1953.