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Overview of electronic cigarettes including history, components, safety and adverse events, efficacy in smoking cessation, pharmacokinetics and epidemiology. This presentation was originally delivered ...

Overview of electronic cigarettes including history, components, safety and adverse events, efficacy in smoking cessation, pharmacokinetics and epidemiology. This presentation was originally delivered to 2nd year pharmacy students as part of a two semester class on pharmacology and toxicology.

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  • Image from NY Times: http://www.nytimes.com/2013/06/13/business/e-cigarettes-are-in-vogue-and-at-a-crossroads.html?pagewanted=all&_r=0
  • Source: http://www.nytimes.com/2013/06/13/business/e-cigarettes-are-in-vogue-and-at-a-crossroads.html?pagewanted=all&_r=0
  • Source: http://rodutobaccotruth.blogspot.com/2012/12/the-e-cigarette-revolution.html
  • Mint and fruit flavors are common
  • Glycerin is sugar alcohol used in a wider variety of preparations. 15 other studies looked for diethylene glycol and did NOT find it. Monoethylene glycol is a component of antifreeze. Fruit, mint, and candy flavors.
  • From 2010-2012: 35 cases of various ages involving leaky cartridges, swallowing cartridge, using cartridge as eye-drop!
  • E-Cig Ad (but accurate?).
  • Sample was adults age 18 to 65. More research with vulnerable populations (elderly, asthma?).
  • “Nicorrette inhalator”
  • “Nicorrette inhalator”
  • Tested the “Categoria” e-Cig. No incentive for study participation.
  • Tested the “Categoria” e-Cig. No incentive for study participation.
  • Tested the “Categoria” e-Cig. This was an early model, common when the study started, but has since been discontinued. No incentive for study participation. Only 1/3rd of people that quit were still using eCigs at week 52 (no transfer of addiction).
  • NYTS is nationally representative sample of all students in U.S. Lifetime use doubled. Current use (past month) went from 0.6 to 1.1! 61% of e-Cig users are current smokers of conventional cigarettes.
  • As of Sept 6, 2013: “Twelve states have laws preventing e-cigarette sales to minors - California, Colorado, Idaho, Iowa, Maryland, Minnesota, New Jersey, New Hampshire, New York, Tennessee, Utah and Wisconsin. New York banned e-cigarette smoking within 100 feet of an entrance to a public or private school.”

electronic cigarettes electronic cigarettes Presentation Transcript

  • Overview of e-Cigarettes Brian J. Piper, Ph.D., M.S. School of Pharmacy, Husson University
  • Goals • • • • • What is an e-Cigarette? History Pharmacokinetics Efficacy Safety
  • History • 1963: Herbert Gilbert patented steam dispensing product • 2003: pharmacist Hon Lik (image) invents eCigarette dispensing nicotine • 2004: Ruyen begins selling eCigs • 2010: FDA decides e-Cigs are drug/delivery devices • 2012: Cigarette companies in US get on board Hon Lik
  • Components Cartridge: 150-300 puffs, may contain flavors
  • Terminology • vapor (n): gaseous particles of drugs • vaping (v): process of inhaling vapor from personal vaporizer • vapers (n): people that use e-Cigs
  • Contents of Cartridge • Majority – propylene glycol ( > half) – glycerin – nicotine (various levels) – various flavors • Trace – diethylene glycol (0.1% in 1/18 samples) – tobacco specific nitrosamines Cahn & Siegel J Public Health Policy 32 (2011) p. 22.
  • Tobacco Specific Nitrosamines Cahn & Siegel J Public Health Policy 32 (2011) p. 22.
  • Nicotine Poisonings • Possible in theory (>500 mg can be fatal), 100 ml refill cartridges contain 72 mg/ml • Not common (yet?) Cantrall J Community Health (2013) in press.
  • Adverse Events • Nicotine increases heart-rate and blood pressure. • E-Cig adverse effects are likely due to inhaling propylene glycol are transient in small/shortterm studies.
  • Adverse Events (N = 40) Coponetto et al. Exp Rev Respir Med 2012: 6(1):63-74.
  • Do e-Cigs reduce craving? • Smokers (1 ppd, age 48, N= 40) that had not smoked for 12 hours were received electronic nicotine delivery device (ENDD, 16 or 0 mg) or usual cigarette • self-report Bullen Tobacco Control 19 (2010) 98-103.
  • What is the PK profile for e-Cigs • Smokers (1 ppd, age 48, N= 40) that had not smoked for 12 hours were received electronic nicotine delivery device (ENDD, 16 or 0 mg) or usual cigarette Cigarette e-Cigarette Tmax (min) 14.3 19.6 Cmax (ng/ml) 13.4* 1.3 * p < .05 Bullen et al. Tobacco Control 19 (2010) 98-103.
  • Do e-Cigs aid smoking cessation? Nicotine Replacement Studies e-Cigarettes Studies # RCTs many 2 psychological support high low participants exclude mentally ill naturalistic 1 year abstinence doubled (20% vs 10%) ?
  • Do e-Cigs aid smoking cessation? • Superiority trial of adults (age = 40s, 18 cig/day). Participants randomized (4:4:1) to: – Elution e-Cig (“placebo”: 0 mg/ml nicotine) – Elution e-Cig (16 mg/ml nicotine) – nicotine patch (21 mg/24 hours) Bullen et al. Lancet 382 (2013) 1629-1637.
  • Do e-Cigs aid smoking cessation? e-Cig (16 mg) (N = 289) e-Cig (0 mg) (N=295) Nicotine Patch (N=77) use of psychological support 40% 36% 36% use of study product at 3 months 51% 53% 18% drop-out of study 17% 27% 22% smoking abstinence at 6 months days to relapse recommend product to friend Bullen et al. Lancet 382 (2013) 1629-1637.
  • Do e-Cigs aid smoking cessation? e-Cig (16 mg) (N = 289) e-Cig (0 mg) (N=295) Nicotine Patch (N=77) use of psychological support 40% 36% 36% use of study product at 3 months 51% 53% 18% drop-out of study 17% 27% 22% smoking abstinence at 6 months 7.3% 5.8% 4.1% days to relapse 35 12 14 recommend product to friend 85% 88% 50% Bullen et al. Lancet 382 (2013) 1629-1637.
  • Do e-Cigs aid in smoking reduction? • Smokers (N = 300), not planning to quit, randomized to: Caponotto et al. (2013) PLoS One 8(6): e66317.
  • Do e-Cigs aid in smoking reduction? • Study completion rates: – A (7.2/7.2 nic): 65% – B (7.2/5.4 nic): 63% – C (0 nic): 55% Caponotto et al. (2013) PLoS One 8(6): e66317.
  • Do e-Cigs aid in smoking reduction? • One-year smoking cessation rates (not significant but … ) – A (7.2/7.2 nic): 13% – B (7.2/5.4 nic): 9% – C (0 nic): 4% Caponotto et al. (2013) PLoS One 8(6): e66317.
  • Free Advertising?
  • Center’s for Disease Control (2013). Morbidity Mortality Weekly Report 62(35), 729-730.
  • Comparison Pros Cons Less adverse health consequences Renormalizing taboo behavior; longterm safety of inhaled propylene glycol vapor? No second-hand smoke Second-hand mist contains nicotine Pharmacokinetics mimics smoking Requires practice Replicates motor pattern of smoking Heavier than cigarette Relieves withdrawal and craving Reinforcing/addictive Cleaner Disposal of cartridge and batteries, some flavors linger in air Readily available Limited quality control on nicotine concentration. Contaminants? Modified from Polosa et al. Harm Reduction Journal 10: 19.
  • Summary • E-cigs, relative to traditional cigarettes, have the potential for substantial harm reduction. • Based on limited and short-term evidence, adverse effects appear minimal. Inconsistency in manufacture is a concern. Each e-cig make/model is different. • E-cigs appear as (in)effective as NRT in smoking cessation. • 1.8 million middle-and high-school students in U.S. tried e-Cigs in 2012.
  • Ethical, Legal Questions+ • What limitations on sales (18, 21?) are warranted? • Should bans on smoking in public places, outdoor and indoor, also apply to e-Cigs? • Should restrictions on advertising (e.g. movies) also apply to e-Cigs? • How will they be taxed? • What is the safety of e-Cigs during pregnancy? • What other drugs (THC, morphine) can be administered using this technology?
  • Key References • C Bullen, H McRobbie, S Thornley, M Glover, R Rin, & M Lausgen, Effect of an electronic nicotine delivery device (e cigarette) on desire to smoke and withdrawal, user preferences, and nicotine delivery: Randomized cross-over trial. Tobacco Control 19 (2010) 98-103. • Z Cahn, M Siegel, Electronic cigarette as a harm reduction strategy for tobacco control: A step forward or a repeat of past mistakes. J Public Health Policy 32 (2011) 16-31. • FL Cantrall, Adverse effects of e-Cigarette exposures. J Community Health (2013) in press.