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BMJ (Clinical Research Ed.) Sep 2019Electronic cigarettes (e-cigarettes) are alternative, non-combustible tobacco products that generate an inhalable aerosol containing nicotine, flavors, propylene glycol,... (Review)
Review
Electronic cigarettes (e-cigarettes) are alternative, non-combustible tobacco products that generate an inhalable aerosol containing nicotine, flavors, propylene glycol, and vegetable glycerin. Vaping is now a multibillion dollar industry that appeals to current smokers, former smokers, and young people who have never smoked. E-cigarettes reached the market without either extensive preclinical toxicology testing or long term safety trials that would be required of conventional therapeutics or medical devices. Their effectiveness as a smoking cessation intervention, their impact at a population level, and whether they are less harmful than combustible tobacco products are highly controversial. Here, we review the evidence on the effects of e-cigarettes on respiratory health. Studies show measurable adverse biologic effects on organ and cellular health in humans, in animals, and in vitro. The effects of e-cigarettes have similarities to and important differences from those of cigarettes. Decades of chronic smoking are needed for development of lung diseases such as lung cancer or chronic obstructive pulmonary disease, so the population effects of e-cigarette use may not be apparent until the middle of this century. We conclude that current knowledge of these effects is insufficient to determine whether the respiratory health effects of e-cigarette are less than those of combustible tobacco products.
Topics: Electronic Nicotine Delivery Systems; Humans; Smoking Cessation; Smoking Prevention; Tobacco Use Cessation Devices
PubMed: 31570493
DOI: 10.1136/bmj.l5275 -
The New England Journal of Medicine Feb 2019E-cigarettes are commonly used in attempts to stop smoking, but evidence is limited regarding their effectiveness as compared with that of nicotine products approved as... (Comparative Study)
Comparative Study Randomized Controlled Trial
BACKGROUND
E-cigarettes are commonly used in attempts to stop smoking, but evidence is limited regarding their effectiveness as compared with that of nicotine products approved as smoking-cessation treatments.
METHODS
We randomly assigned adults attending U.K. National Health Service stop-smoking services to either nicotine-replacement products of their choice, including product combinations, provided for up to 3 months, or an e-cigarette starter pack (a second-generation refillable e-cigarette with one bottle of nicotine e-liquid [18 mg per milliliter]), with a recommendation to purchase further e-liquids of the flavor and strength of their choice. Treatment included weekly behavioral support for at least 4 weeks. The primary outcome was sustained abstinence for 1 year, which was validated biochemically at the final visit. Participants who were lost to follow-up or did not provide biochemical validation were considered to not be abstinent. Secondary outcomes included participant-reported treatment usage and respiratory symptoms.
RESULTS
A total of 886 participants underwent randomization. The 1-year abstinence rate was 18.0% in the e-cigarette group, as compared with 9.9% in the nicotine-replacement group (relative risk, 1.83; 95% confidence interval [CI], 1.30 to 2.58; P<0.001). Among participants with 1-year abstinence, those in the e-cigarette group were more likely than those in the nicotine-replacement group to use their assigned product at 52 weeks (80% [63 of 79 participants] vs. 9% [4 of 44 participants]). Overall, throat or mouth irritation was reported more frequently in the e-cigarette group (65.3%, vs. 51.2% in the nicotine-replacement group) and nausea more frequently in the nicotine-replacement group (37.9%, vs. 31.3% in the e-cigarette group). The e-cigarette group reported greater declines in the incidence of cough and phlegm production from baseline to 52 weeks than did the nicotine-replacement group (relative risk for cough, 0.8; 95% CI, 0.6 to 0.9; relative risk for phlegm, 0.7; 95% CI, 0.6 to 0.9). There were no significant between-group differences in the incidence of wheezing or shortness of breath.
CONCLUSIONS
E-cigarettes were more effective for smoking cessation than nicotine-replacement therapy, when both products were accompanied by behavioral support. (Funded by the National Institute for Health Research and Cancer Research UK; Current Controlled Trials number, ISRCTN60477608 .).
Topics: Adult; Electronic Nicotine Delivery Systems; Female; Humans; Male; Middle Aged; Nicotine; Smoking Cessation; Tobacco Use Cessation Devices; Tobacco Use Disorder; Treatment Outcome; Vaping
PubMed: 30699054
DOI: 10.1056/NEJMoa1808779 -
International Journal of Environmental... Mar 2020The aim of this review of reviews was to collate the latest evidence from systematic reviews about the maternal and child health outcomes of being exposed to tobacco and... (Review)
Review
Exposure to Tobacco, Environmental Tobacco Smoke and Nicotine in Pregnancy: A Pragmatic Overview of Reviews of Maternal and Child Outcomes, Effectiveness of Interventions and Barriers and Facilitators to Quitting.
The aim of this review of reviews was to collate the latest evidence from systematic reviews about the maternal and child health outcomes of being exposed to tobacco and nicotine during pregnancy; the effectiveness of interventions designed to reduce these exposures, and barriers to and facilitators of smoking cessation during pregnancy. Two databases were searched to obtain systematic reviews published from 2010 to 2019. Pertinent data from 76 articles were summarized using a narrative synthesis (PROSPERO reference: CRD42018085896). Exposure to smoke or tobacco in other forms during pregnancy is associated with an increased risk of obstetric complications and adverse health outcomes for children exposed in-utero. Counselling interventions are modestly effective, while incentive-based interventions appear to substantially increase smoking cessation. Nicotine replacement therapy is effective during pregnancy but the evidence is not conclusive. Predictors and barriers to smoking cessation in pregnancy are also discussed. Smoking during pregnancy poses substantial risk to mother's and child's health. Psychosocial interventions and nicotine replacement therapy (NRT) appear to be effective in helping pregnant women quit smoking. Barriers to smoking cessation must be identified and steps taken to eradicate them in order to reduce smoking among pregnant women. More research is needed on smoking cessation medications and e-cigarettes.
Topics: Child; Electronic Nicotine Delivery Systems; Female; Humans; Nicotine; Pregnancy; Smoking Cessation; Nicotiana; Tobacco Smoke Pollution; Tobacco Use Cessation Devices
PubMed: 32204415
DOI: 10.3390/ijerph17062034 -
JAMA Internal Medicine Nov 2020Smoking is a leading cause of premature death globally. Smartphone applications for smoking cessation are ubiquitous and address barriers to accessing traditional... (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
Smoking is a leading cause of premature death globally. Smartphone applications for smoking cessation are ubiquitous and address barriers to accessing traditional treatments, yet there is limited evidence for their efficacy.
OBJECTIVE
To determine the efficacy of a smartphone application for smoking cessation based on acceptance and commitment therapy (ACT) vs a National Cancer Institute smoking cessation application based on US clinical practice guidelines (USCPG).
DESIGN, SETTING, AND PARTICIPANTS
A 2-group, stratified, double-blind, individually randomized clinical trial was conducted from May 27, 2017, to September 28, 2018, among 2415 adult cigarette smokers (n = 1214 for the ACT-based smoking cessation application group and n = 1201 for the USCPG-based smoking cessation application group) with 3-, 6-, and 12-month postrandomization follow-up. The study was prespecified in the trial protocol. Follow-up data collection started on August 26, 2017, and ended at the last randomized participant's 12-month follow-up survey on December 23, 2019. Data were analyzed from February 25 to April 3, 2020. The primary analysis was performed on a complete-case basis, with intent-to-treat missing as smoking and multiple imputation sensitivity analyses.
INTERVENTIONS
iCanQuit, an ACT-based smoking cessation application, which taught acceptance of smoking triggers, and the National Cancer Institute QuitGuide, a USCPG-based smoking cessation application, which taught avoidance of smoking triggers.
MAIN OUTCOMES AND MEASURES
The primary outcome was self-reported 30-day point prevalence abstinence (PPA) at 12 months after randomization. Secondary outcomes were 7-day PPA at 12 months after randomization, prolonged abstinence, 30-day and 7-day PPA at 3 and 6 months after randomization, missing data imputed with multiple imputation or coded as smoking, and cessation of all tobacco products (including e-cigarettes) at 12 months after randomization.
RESULTS
Participants were 2415 adult cigarette smokers (1700 women [70.4%]; 1666 White individuals [69.0%] and 868 racial/ethnic minorities [35.9%]; mean [SD] age at enrollment, 38.2 [10.9] years) from all 50 US states. The 3-month follow-up data retention rate was 86.7% (2093), the 6-month retention rate was 88.4% (2136), and the 12-month retention rate was 87.2% (2107). For the primary outcome of 30-day PPA at the 12-month follow-up, iCanQuit participants had 1.49 times higher odds of quitting smoking compared with QuitGuide participants (28.2% [293 of 1040] vs 21.1% [225 of 1067]; odds ratio [OR], 1.49; 95% CI, 1.22-1.83; P < .001). Effect sizes were very similar and statistically significant for 7-day PPA at the 12-month follow-up (OR, 1.35; 95% CI, 1.12-1.63; P = .002), prolonged abstinence at the 12-month follow-up (OR, 2.00; 95% CI, 1.45-2.76; P < .001), abstinence from all tobacco products (including e-cigarettes) at the 12-month follow-up (OR, 1.60; 95% CI, 1.28-1.99; P < .001), 30-day PPA at 3-month follow-up (OR, 2.20; 95% CI, 1.68-2.89; P < .001), 30-day PPA at 6-month follow-up (OR, 2.03; 95% CI, 1.63-2.54; P < .001), 7-day PPA at 3-month follow-up (OR, 2.04; 95% CI, 1.64-2.54; P < .001), and 7-day PPA at 6-month follow-up (OR, 1.73; 95% CI, 1.42-2.10; P < .001).
CONCLUSIONS AND RELEVANCE
This trial provides evidence that, compared with a USCPG-based smartphone application, an ACT-based smartphone application was more efficacious for quitting cigarette smoking and thus can be an impactful treatment option.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02724462.
Topics: Adult; Double-Blind Method; Female; Follow-Up Studies; Humans; Male; Mobile Applications; Retrospective Studies; Smartphone; Smoking Cessation; Tobacco Use Cessation Devices
PubMed: 32955554
DOI: 10.1001/jamainternmed.2020.4055 -
Nature Medicine May 2022Nicotine replacement therapy, in the form of nicotine patches, is commonly offered to pregnant women who smoke to help them to stop smoking, but this approach has... (Randomized Controlled Trial)
Randomized Controlled Trial
Nicotine replacement therapy, in the form of nicotine patches, is commonly offered to pregnant women who smoke to help them to stop smoking, but this approach has limited efficacy in this population. Electronic cigarettes (e-cigarettes) are also used by pregnant women who smoke but their safety and efficacy in pregnancy are unknown. Here, we report the results of a randomized controlled trial in 1,140 participants comparing refillable e-cigarettes with nicotine patches. Pregnant women who smoked were randomized to e-cigarettes (n = 569) or nicotine patches (n = 571). In the unadjusted analysis of the primary outcome, validated prolonged quit rates at the end of pregnancy in the two study arms were not significantly different (6.8% versus 4.4% in the e-cigarette and patch arms, respectively; relative risk (RR) = 1.55, 95%CI: 0.95-2.53, P = 0.08). However, some participants in the nicotine patch group also used e-cigarettes during the study. In a pre-specified sensitivity analysis excluding abstinent participants who used non-allocated products, e-cigarettes were more effective than patches (6.8% versus 3.6%; RR = 1.93, 95%CI: 1.14-3.26, P = 0.02). Safety outcomes included adverse events and maternal and birth outcomes. The safety profile was found to be similar for both study products, however, low birthweight (<2,500 g) was less frequent in the e-cigarette arm (14.8% versus 9.6%; RR = 0.65, 95%CI: 0.47-0.90, P = 0.01). Other adverse events and birth outcomes were similar in the two study arms. E-cigarettes might help women who are pregnant to stop smoking, and their safety for use in pregnancy is similar to that of nicotine patches. ISRCTN62025374.
Topics: Electronic Nicotine Delivery Systems; Female; Humans; Nicotine; Pregnancy; Smoking Cessation; Tobacco Use Cessation Devices
PubMed: 35577966
DOI: 10.1038/s41591-022-01808-0 -
Health Technology Assessment... Aug 2019Over the past few years, a large number of smokers in the UK have stopped smoking with the help of e-cigarettes. So far, UK Stop Smoking Services (SSSs) have been... (Clinical Trial)
Clinical Trial
BACKGROUND
Over the past few years, a large number of smokers in the UK have stopped smoking with the help of e-cigarettes. So far, UK Stop Smoking Services (SSSs) have been reluctant to include e-cigarettes among their treatment options because data on their efficacy compared with the licensed medications are lacking.
OBJECTIVE
The objective was to compare the efficacy of refillable e-cigarettes and nicotine replacement therapy (NRT) products, when accompanied by weekly behavioural support.
DESIGN
A randomised controlled trial comparing e-cigarettes and NRT.
SETTING
Three sites that provide local SSSs.
PARTICIPANTS
The participants were 886 smokers seeking help to quit smoking, aged ≥ 18 years, not pregnant or breastfeeding, with no strong preference to use or not to use NRT or e-cigarettes in their quit attempt, and currently not using NRT or e-cigarettes. A total of 886 participants were randomised but two died during the study (one in each study arm) and were not included in the analysis.
INTERVENTIONS
The NRT arm ( = 446) received NRT of their choice (single or combination), provided for up to 12 weeks. The e-cigarette arm ( = 438) received an e-cigarette starter pack and were encouraged to buy addtional e-liquids and e-cigarette products of their choice. Both arms received the same standard behavioural support. Participants attended weekly sessions at their SSS and provided outcome data at 4 weeks. They were then followed up by telephone at 6 and 12 months. Participants reporting abstinence or at least 50% reduction in cigarette consumption at 12 months were invited to attend for carbon monoxide (CO) validation. Participants/researchers could not be blinded to the intervention.
MAIN OUTCOME MEASURES
The primary outcome was CO-validated sustained abstinence rates at 52 weeks. Participants lost to follow-up or not providing biochemical validation were included as non-abstainers. Secondary outcomes included abstinence at other time points, reduction in smoke intake, treatment adherence and ratings, elicited adverse reactions, and changes in self-reported respiratory health. A cost-efficacy analysis of the intervention was also conducted.
RESULTS
The 1-year quit rate was 9.9% in the NRT arm and 18.0% in the e-cigarette arm (risk ratio 1.83, 95% confidence interval 1.30 to 2.58; < 0.001). The e-cigarette arm had significantly higher validated quit rates at all time points. Participants in the e-cigarette arm showed significantly better adherence and experienced fewer urges to smoke throughout the initial 4 weeks of their quit attempt than those in the NRT arm, and gave their allocated product more favourable ratings. They were also more likely to be still using their allocated product at 1 year (39.5% vs. 4.3%, χ = 161.4; < 0.001). Participants assigned to e-cigarettes reported significantly less coughing and phlegm at 1 year than those assigned to NRT (controlling for smoking status). A detailed economic analysis confirmed that, because e-cigarettes incur lower NHS costs than NRT and generate a higher quit rate, e-cigarette use is more cost-effective.
LIMITATIONS
The results may not be generalisable to other types of smokers or settings, or to cartridge-based e-cigarettes.
CONCLUSIONS
Within the context of multisession treatment for smokers seeking help, e-cigarettes were significantly more effective than NRT. If SSSs provide e-cigarette starter packs, it is likely to boost their success rates and improve their cost-efficacy.
FUTURE WORK
The efficacy of e-cigarettes provided with different levels of support will show whether smokers should be encouraged to switch to vaping within support services or whether e-cigarettes can be recommended with less intensive or no support.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN60477608.
FUNDING
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 23, No. 43. See the NIHR Journals Library website for further project information. The trial was supported by the Cancer Research UK Prevention Trials Unit (grant A16893).
Topics: Adult; Behavior Therapy; Cost-Benefit Analysis; Electronic Nicotine Delivery Systems; Female; Humans; Male; Smoking Cessation; Tobacco Use Cessation Devices; United Kingdom
PubMed: 31434605
DOI: 10.3310/hta23430 -
Addictive Behaviors May 2013Long-term smokeless tobacco (ST) use is associated with cardiovascular disease and cancer, but not all ST users want to quit. Previous studies have evaluated the... (Comparative Study)
Comparative Study Randomized Controlled Trial
Long-term smokeless tobacco (ST) use is associated with cardiovascular disease and cancer, but not all ST users want to quit. Previous studies have evaluated the effectiveness of nicotine lozenges and tobacco-free snuff for reducing ST use among ST users not ready to quit, but no comparative effectiveness trials of these two products have been conducted. We conducted a multicenter, randomized clinical pilot study evaluating the comparative effectiveness of the 4-mg nicotine lozenge and tobacco-free snuff for reducing ST use and increasing tobacco abstinence among ST users with no intention of quitting in the next 30 days. Participants received 8 weeks of treatment and behavioral counseling on tobacco reduction strategies with follow-up to 26 weeks. We randomized 81 participants (40 nicotine lozenges, 41 tobacco-free snuff). No significant differences in reduction were observed between the two groups at weeks 8, 12, and 26. No significant differences were observed between groups in nicotine withdrawal or tobacco craving. However, both groups significantly reduced (p<.001) ST use in cans/week and dips/day from baseline which was sustained through the end-of-study. The observed biochemically-confirmed abstinence rates at week 26 were similar between groups (12% vs. 12%, one-tailed p=.615). The 4-mg nicotine lozenge and the tobacco-free snuff both appear to be effective and comparable for reducing ST use among ST users not ready to quit in the next 30 days.
Topics: Adult; Aged; Female; Humans; Male; Middle Aged; Pilot Projects; Substance Withdrawal Syndrome; Tobacco Use Cessation; Tobacco Use Cessation Devices; Tobacco Use Disorder; Tobacco, Smokeless; Young Adult
PubMed: 23454876
DOI: 10.1016/j.addbeh.2013.01.023 -
Chronic Respiratory Disease May 2016
Topics: Behavior Therapy; Health Promotion; Humans; Motivation; Product Packaging; Public Policy; Smoke-Free Policy; Smoking Cessation; Taxes; Tobacco Products; Tobacco Use Cessation Devices; Tobacco Use Disorder
PubMed: 27440789
DOI: 10.1177/1479972316647179 -
Australian Journal of General Practice Jul 2022Under 2021 regulations, a prescription is required to import nicotine liquid for vaping or to purchase it from Australian pharmacies.
BACKGROUND
Under 2021 regulations, a prescription is required to import nicotine liquid for vaping or to purchase it from Australian pharmacies.
OBJECTIVE
This article outlines 1) the latest evidence on vaping, 2) devices and liquids available, 3) how to counsel smokers about vaping and 4) how to write nicotine prescriptions.
DISCUSSION
Vaping is a second-line quitting aid for adult smokers unable to quit with approved treatments and is the most popular quitting method in Australia. It is safer than smoking and more effective than nicotine replacement therapy. It is necessary that general practitioners (GPs) know how vaping works, what products are available, when to consider vaping for smoking patients and how to counsel smokers about it. GPs will be asked to write prescriptions for patients to purchase nicotine liquid from Australian pharmacies under the Authorised Provider Scheme or import it legally. Vaping should cease within 3-6 months if possible; however, long-term vaping is far safer than relapsing to smoking.
Topics: Adult; Australia; Humans; Nicotine; Smoking Cessation; Tobacco Use Cessation Devices; Vaping
PubMed: 35773160
DOI: 10.31128/AJGP-08-21-6139 -
Neuropharmacology Nov 2020The landscape of worldwide tobacco use is changing, with a decrease in traditional smoking and an exponential rise in electronic cigarette use. No new nicotine cessation... (Review)
Review
The landscape of worldwide tobacco use is changing, with a decrease in traditional smoking and an exponential rise in electronic cigarette use. No new nicotine cessation pharmacotherapies have come to market in the last 10 years. The current therapies that have been approved by the United States Food and Drug Administration for nicotine cessation include nicotine replacement therapy, varenicline, a nicotinic acetylcholine receptor partial agonist, and the atypical antidepressant bupropion. Nicotine replacement therapy and varenicline both act on nicotinic acetylcholine receptors. Bupropion inhibits the dopamine transporter, the norepinephrine transporter, and the nicotinic acetylcholine receptors to inhibit smoking behavior. Notwithstanding these treatments, rates of successful nicotine cessation in clinical trials remain low. Recent pharmacological approaches to improve nicotine cessation rates in animal models have turned their focus away from activating nicotinic acetylcholine receptors. The present review focuses on such pharmacological approaches, including nicotine vaccines, anti-nicotine antibodies, nicotine-degrading enzymes, cannabinoids, and metformin. Both immunopharmacological and enzymatic approaches rely on restricting and degrading nicotine within the periphery, thus preventing psychoactive effects of nicotine on the central nervous system. In contrast, pharmacologic inhibition of the enzymes which degrade nicotine could affect smoking behavior. Cannabinoid receptor agonists and antagonists interact with the dopamine reward pathway and show efficacy in reducing nicotine addiction-like behaviors in preclinical studies. Metformin is currently approved by the Food and Drug Administration for the treatment of diabetes. It activates specific intracellular kinases that may protect against the lower metabolism, higher oxidation, and inflammation that are associated with nicotine withdrawal. Further studies are needed to investigate non-nicotinic targets to improve the treatment of tobacco use disorder. This article is part of the special issue on 'Contemporary Advances in Nicotine Neuropharmacology'.
Topics: Animals; Antidepressive Agents; Bupropion; Disease Models, Animal; Electronic Nicotine Delivery Systems; Humans; Nicotinic Agonists; Receptors, Nicotinic; Smoking Cessation; Smoking Cessation Agents; Tobacco Use Cessation Devices; Tobacco Use Disorder; Varenicline
PubMed: 32758566
DOI: 10.1016/j.neuropharm.2020.108225