IMPORTANCE Electronic cigarettes (e-cigarettes) for smoking cessation remain controversial. OBJECTIVE To evaluate e-cigarettes with individual counseling for smoking cessation. DESIGN, SETTING, AND PARTICIPANTS A randomized clinical trial enrolled adults motivated to quit smoking from November 2016 to September 2019 at 17 Canadian sites (801 individuals screened; 274 ineligible and 151 declined). Manufacturing delays resulted in early termination (376/486 participants, 77% of target). Outcomes through 24 weeks (March 2020) are reported. INTERVENTIONS Randomization to nicotine e-cigarettes (n = 128), nonnicotine e-cigarettes (n = 127), or no e-cigarettes (n = 121) for 12 weeks. All groups received individual counseling. MAIN OUTCOMES AND MEASURESThe primary end point was point prevalence abstinence (7-day recall, biochemically validated using expired carbon monoxide) at 12 weeks, changed from 52 weeks following early termination. Participants missing data were assumed to be smoking. The 7 secondary end points, examined at multiple follow-ups, were point prevalence abstinence at other follow-ups, continuous abstinence, daily cigarette consumption change, serious adverse events, adverse events, dropouts due to adverse effects, and treatment adherence. RESULTS Among 376 randomized participants (mean age, 52 years; 178 women [47%]), 299 (80%) and 278 (74%) self-reported smoking status at 12 and 24 weeks, respectively. Point prevalence abstinence was significantly greater for nicotine e-cigarettes plus counseling vs counseling alone at 12 weeks (21.9% vs 9.1%; risk difference [RD], 12.8 [95% CI, 4.0 to 21.6]) but not 24 weeks (17.2% vs 9.9%; RD, 7.3 [95% CI,). Point prevalence abstinence for nonnicotine e-cigarettes plus counseling was not significantly different from counseling alone at 12 weeks (17.3% vs 9.1%; RD, 8.2 [95% CI, -0.1 to 16.6]), but was significantly greater at 24 weeks (20.5% vs 9.9%; RD, 10.6 [95% CI, 1.8 to 19.4]). Adverse events were common (nicotine e-cigarette with counseling: 120 [94%]; nonnicotine e-cigarette with counseling: 118 [93%]; counseling only: 88 [73%]), with the most common being cough (64%) and dry mouth (53%).CONCLUSIONS AND RELEVANCE Among adults motivated to quit smoking, nicotine e-cigarettes plus counseling vs counseling alone significantly increased point prevalence abstinence at 12 weeks. However, the difference was no longer significant at 24 weeks, and trial interpretation is limited by early termination and inconsistent findings for nicotine and nonnicotine e-cigarettes, suggesting further research is needed.
Background: Smoking cessation improves morbidity and mortality among smokers who achieve long-term abstinence. Many smokers are using electronic cigarettes (e-cigarettes) to attempt to quit, despite a lack of data concerning their efficacy and safety for smoking cessation. Methods: The Evaluating the Efficacy of E-Cigarette use for Smoking Cessation (E3) trial is a multicentre randomized controlled trial (NCT02417467) with a treatment period of 12 weeks and follow-up of 52 weeks. A total of 376 participants motivated to quit smoking were enrolled at 17 Canadian centres (November 2016 to September R ESUM E Contexte : Le sevrage tabagique am eliore la morbidit e et la mortalit e chez les fumeurs qui parviennent à une abstinence à long term. De nombreux fumeurs utilisent des cigarettes electroniques (e-cigarettes) pour tenter d'arrêter de fumer, malgr e le manque de donn ees concernant leur efficacit e et leur s ecurit e pour le sevrage tabagique. M ethodes : L'essai "Evaluation l'utilisation de la cigarette Électronique (E3)" pour cesser de fumer (E3)" est un essai contrôl e randomis e multicentrique (NCT02417467) avec une p eriode de traitement de 12 semaines et un suivi de 52 semaines. Au total, 376 participants More than half of adults who smoke conventional cigarettes attempted to quit in the past year, many using the increasingly popular electronic cigarette (e-cigarette). 1 Between 2014 and 2016, North Americans who made a quit attempt were more likely to use an e-cigarette (35.3%) as a cessation tool than the nicotine patch or gum (24.5%), or an approved medication such as bupropion (Zyban) or varenicline (Champix/Chantix) (12.2%). 2 The available data from randomized controlled trials (RCTs), which varied substantially in designs and populations (Supplemental Appendix S1), suggest that nicotine ecigarettes may be modestly more efficacious for smoking cessation than conventional smoking cessation therapies. 3-6 However, many of these RCTs were limited by small sample sizes, conducted in smokers not motivated to quit, or were otherwise not designed to evaluate the efficacy of e-cigarettes compared with conventional therapies. 3,5,7-11 The recent outbreak of e-cigarette, or vaping, product useassociated lung injury (EVALI) in the United States has also brought into question the safety of e-cigarettes. As of mid-January 2020, a total of 2668 people were hospitalized, and 60 had died after using e-cigarettes. 12 Mounting evidence suggests that the outbreak is likely due to the use of e-cigarette liquids containing cannabis derivatives. 13 Although most commercially available e-cigarettes are therefore unlikely to cause EVALI, additional data are required concerning their safety. The Evaluating the Efficacy of E-Cigarette use for Smoking Cessation (E3) trial will improve our understanding of the efficacy and safety of e-cigarettes for smoking cessation in North America. Methods Study design The E3 trial (clinicaltrials.gov registration NCT02417467) is a multicentre, three-arm RCT with a treatment period of 12 CJC...
BackgroundThe North American opioid crisis is marked by high opioid-related mortality and morbidity, including opioid use-associated infections (OUAIs). Users of pharmaceutical and non-pharmaceutical opioids are at an increased risk of acquiring hepatitis C (HCV), human immunodeficiency virus (HIV), and other infections. No high-level evidence, however, has been synthesized regarding effectiveness of interventions to prevent OUAIs in legal, and illegal/mixed opioid users. The aim of the study is to synthesize available systematic review (SR)–level evidence on the scope and effectiveness of interventions to prevent OUAIs among opioid users.MethodsA SR of SRs approach was applied. We searched PubMed, Embase, PsycINFO, Cochrane Database of Systematic Reviews, Epistemonikos and Google Scholar from inception to September 2020. Data selection and extraction were performed independently by three researchers. Risk of bias and quality of evidence were assessed using the AMSTAR2 tool. Results were narratively synthesized. Strength of evidence for each category was reported.ResultsEleven of twelve identified SRs included interventions to prevent HCV/HIV transmission in persons who inject drugs (PWID), including opioids. One SR evaluated interventions to prevent recurrent infectious endocarditis. There was sufficient and tentative SR of SRs-level evidence for the effectiveness of opioid substitution therapy (OST) in preventing HIV and HCV, respectively. We found tentative evidence to support effectiveness of needle/syringe exchange programs (NSP) in HIV prevention, and sufficient evidence to support effectiveness of the combined OST and NSP in HCV prevention. There was insufficient SR-level evidence to support or discount effectiveness of other interventions to prevent OUAIs. No SR focused on non-PWID populations.ConclusionSR-level evidence supports the use of OST, NSP, and combined interventions for the reduction of HCV and HIV transmission in PWID. More research on prevention of other OUAIs and on prevention of OUAIs in non-PWID populations is urgently needed.Systematic Review Registration:Registered in PROSPERO on July 30, 2020. https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=195929, identifier: #195929.
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