The Role of Electronic Cigarettes for Tobacco Dependence Treatment

ran across this paper here: http://www.psychiatrictimes.com/addiction/role-electronic-cigarettes-tobacco-dependence-treatment/page/0/1 The Role of Electronic Cigarettes for Tobacco Dependence Treatment News | November 20, 2013 | Addiction, Substance Use Disorder By Chris Bullen, MBChB, MPH, PhD Electronic cigarettes (e-cigarettes) are a diverse and rapidly evolving range of battery-operated devices that vaporize nicotine for inhalation. Millions of people have purchased them.1 Indeed, e-cigarette sales are increasing so rapidly some analysts predict that they will overtake cigarette sales within a decade.2 Despite this mass use of a novel inhalable product, there is a remarkable paucity of reliable efficacy and safety data to inform debate over their place in treating tobacco dependence.3,4 Surveys show many smokers try e-cigarettes to cut down tobacco use or quit smoking,5,6 and studies show they are capable of attenuating tobacco withdrawal just as effectively as nicotine replacement therapy (NRT).7,8 Part of their appeal may be their simulation of the behavioral and sensory dimensions of smoking. But e-cigarette use could lead to harm: toxins have been found in e-cigarette fluid and vapor.9,10 However, the levels are similar to those found in NRT and far lower than in cigarette smoke.11 Indeed, a recent review deemed e-cigarettes to be very unlikely to pose significant risks to smokers.12 We conducted a pragmatic randomized-controlled superiority trial in Auckland, New Zealand, between September 2011 and July 2013, to assess whether e-cigarettes with nicotine were more effective for smoking cessation than nicotine patches.13 We included a blind comparison with “placebo” e-cigarettes (containing no nicotine). We hypothesized that nicotine e-cigarettes would be more effective than patches and placebo e-cigarettes for smoking reduction, tobacco dependence, and relief of withdrawal symptoms, and that they would have no greater risk of adverse events than nicotine patches. Smokers aged ? 18 years who wanted to quit were randomized to 16 mg nicotine e-cigarettes, nicotine patches (21 mg patch, one daily), or placebo e-cigarettes (no nicotine), from 1 week before until 12 weeks after quit day, with low-intensity behavioral support via voluntary telephone counseling. The primary outcome was biochemically verified continuous abstinence at 6 months (exhaled breath carbon monoxide measurement < 10 ppm). Primary analysis was by intention to treat. A total of 657 people were randomized (289 to nicotine e-cigarettes, 295 to patches, and 73 to placebo e-cigarettes). At 6 months, verified abstinence was 7·3% (21 of 289) with nicotine e-cigarettes, 5·8% (17 of 295) with patches, and 4·1% (3 of 73) with placebo e-cigarettes (risk difference for nicotine e-cigarette versus patches 1·51 [95% CI – 2·49 to 5·51]; for nicotine e-cigarettes versus placebo e-cigarettes 3·16 [95% CI – 2·29 to 8·61]). Achievement of abstinence was substantially lower than anticipated for the power calculation, so there was insufficient statistical power to conclude superiority of nicotine e-cigarettes to patches or to placebo e-cigarettes. However, they were at least as effective as patches. Importantly, we found no evidence of an association between adverse events and study product. We concluded that e-cigarettes, with or without nicotine, were modestly effective at helping smokers to quit, with similar achievement of abstinence as with nicotine patches, and few adverse events. At 6 months, 29% of the nicotine e-cigarettes group and 35% of the placebo e-cigarettes group persisted with e-cigarette use, while only 8% in the patches group were still using patches. Among those in the nicotine e-cigarettes group verified as abstinent, 38% still used e-cigarettes at 6 months; among non-quitters, 29% still used e-cigarettes. The e-cigarette users were very enthusiastic about them: 85% of participants allocated to e-cigarettes would recommend them to a friend wanting to quit, and 40% liked their tactile, cigarette-like qualities, sensory familiarity, perceived health benefits, taste, absence of cigarette odor, and ease of use. Our research showed they are at least as effective and safe as NRT patch for helping people quit in the short term. Following a risk:benefit assessment, they may be an option for smokers who have tried all other evidence-based treatments yet repeatedly relapsed to smoking, or for whom behavioral dependence is a major feature of their addiction to cigarettes. If considering them to patients using psychiatric medications, the same cautions would apply as for prescribing NRT. Stopping smoking affects the metabolism of a number of drugs used in the management of mental illness. Tobacco smoke contains substances such as polycyclic aromatic hydrocarbons (PAHs) that lead to increased expression of cytochrome P450 (CYP450) enzymes in the liver and other tissues. People on clozapine and olanzapine who stop smoking should have their drug levels monitored and their doses lowered when they stop smoking, some experts suggest by approximately 35%.14 The need for dosage adjustment with other psychiatric medications is not as strong. E-cigarettes therefore may have a role to play in tobacco dependence treatment, but more research is needed to establish benefits and potential harms when used beyond 6 to 12 months, as seems to be commonplace—around one third of users in our study. To improve efficacy and safety, the unreliability of many of these devices, the lack of quality controls in liquid manufacture, and child-proofing of the liquid containers will probably need to be addressed by light-touch regulatory means. More broadly, the place of e-cigarettes in population-level tobacco control is debated. Could they be the breakthrough product needed to save millions of lives if used as low-harm substitutes for tobacco cigarettes? Or could they “re-normalize” smoking behavior and be a gateway to tobacco for many people? Sensible, research-informed regulation is needed, sufficient to ensure public safety while at the same time not cutting off what may be a lifeline for the many smokers who have tried to quit repeatedly using the full range of standard tobacco dependence treatments, but failed to do.