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ObjectivesTo measure the short-term effects of an electronic nicotine delivery device (“e cigarette”, ENDD) on desire to smoke, withdrawal symptoms, acceptability, pharmacokinetic properties and adverse effects.DesignSingle blind randomised repeated measures cross-over trial of the Ruyan V8 ENDD.SettingUniversity research centre in Auckland, New Zealand.Participants40 adult dependent smokers of 10 or more cigarettes per day.InterventionsParticipants were randomised to use ENDDs containing 16 mg nicotine or 0 mg capsules, Nicorette nicotine inhalator or their usual cigarette on each of four study days 3 days apart, with overnight smoking abstinence before use of each product.Main outcome measuresThe primary outcome was change in desire to smoke, measured as “area under the curve” on an 11-point visual analogue scale before and at intervals over 1 h of use. Secondary outcomes included withdrawal symptoms, acceptability and adverse events. In nine participants, serum nicotine levels were also measured.ResultsOver 60 min, participants using 16 mg ENDD recorded 0.82 units less desire to smoke than the placebo ENDD (p=0.006). No difference in desire to smoke was found between 16 mg ENDD and inhalator. ENDDs were more pleasant to use than inhalator (p=0.016) and produced less irritation of mouth and throat (p<0.001). On average, the ENDD increased serum nicotine to a peak of 1.3 mg/ml in 19.6 min, the inhalator to 2.1 ng/ml in 32 min and cigarettes to 13.4 ng/ml in 14.3 min.ConclusionsThe 16 mg Ruyan V8 ENDD alleviated desire to smoke after overnight abstinence, was well tolerated and had a pharmacokinetic profile more like the Nicorette inhalator than a tobacco cigarette. Evaluation of the ENDD for longer-term safety, potential for long-term use and efficacy as a cessation aid is needed.Trial registrationNo.12607000587404, Australia and New Zealand Clinical Trials Register

The evidence of relative safety of ECs and of the lack of any gateway effect is much stronger than any evidence to the contrary; misinforming smokers and health professionals about the relative risks of smoking and vaping is wrong; and discouraging smokers from using ECs is irresponsible, however much the safe sounding \"precautionary principle\" is invoked.

Electronic cigarettes (e-cigarettes) can deliver nicotine and mitigate tobacco withdrawal and are used by many smokers to assist quit attempts. We investigated whether e-cigarettes are more effective than nicotine patches at helping smokers to quit. We did this pragmatic randomised-controlled superiority trial in Auckland, New Zealand, between Sept 6, 2011, and July 5, 2013. Adult (≥18 years) smokers wanting to quit were randomised (with computerised block randomisation, block size nine, stratified by ethnicity [Māori; Pacific; or non-Māori, non-Pacific], sex [men or women], and level of nicotine dependence [>5 or ≤5 Fagerström test for nicotine dependence]) in a 4:4:1 ratio 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 behavioural support via voluntary telephone counselling. 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. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12610000866000. 657 people were randomised (289 to nicotine e-cigarettes, 295 to patches, and 73 to placebo e-cigarettes) and were included in the intention-to-treat analysis. 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% (three of 73) with placebo e-cigarettes (risk difference for nicotine e-cigarette vs patches 1·51 [95% CI −2·49 to 5·51]; for nicotine e-cigarettes vs placebo e-cigarettes 3·16 [95% CI −2·29 to 8·61]). Achievement of abstinence was substantially lower than we anticipated for the power calculation, thus we had insufficient statistical power to conclude superiority of nicotine e-cigarettes to patches or to placebo e-cigarettes. We identified no significant differences in adverse events, with 137 events in the nicotine e-cigarettes group, 119 events in the patches group, and 36 events in the placebo e-cigarettes group. We noted no evidence of an association between adverse events and study product. 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. Uncertainty exists about the place of e-cigarettes in tobacco control, and more research is urgently needed to clearly establish their overall benefits and harms at both individual and population levels. Health Research Council of New Zealand.

In this trial involving smokers who called the New Zealand national quitline, cytisine (a partial agonist of the nicotinic acetylcholine receptor) was superior to nicotine-replacement therapy in helping smokers quit. Nausea and sleep disorders were more frequent with cytisine. Cytisine is a plant-based alkaloid found in members of the Leguminosae family. 1 , 2 Like varenicline, cytisine is a partial agonist of nicotinic acetylcholine receptors (nAChRs), with an affinity for the α4β2 receptor subtype, 3 and a half-life of 4.8 hours. 4 Cytisine is a generic agent currently manufactured by Sopharma as Tabex and by Aflofarm Pharma as Desmoxan. It has been available both with and without prescription for smoking cessation since the 1960s, largely in Eastern Europe. 5 Four systematic reviews report cytisine to be superior to placebo for short-term and long-term abstinence. 6 – 9 When taken at the recommended dosage (1.5 to 9 . . .

Objectives: General practitioners (GPs) are the main source of referrals to specialist smoking cessation services (SSCS), but the referral rates are low. We evaluated effects of a brief GP training session on the number of referrals received by their local SSCS. Methods: A cluster-randomised controlled trial was undertaken across three East London primary care trusts. A total of 91 GPs were randomly allocated to a training session or usual care. Participants in the intervention arm were offered a 40-min training session addressing the rationale and skills for referral of smokers for treatment. Participants in the usual care arm received referral guidance by post. The main outcome measure was the number of referrals recorded by the SSCS over 3 months after the intervention. Results: Over the 3-month baseline period the average number of referrals per GP was 1.0 and 0.6 in the intervention and usual care arms, respectively. During the post-intervention period the mean number of referrals was 6.4 and 1.8 per GP. When adjusting for baseline variables the incidence rate ratio for the referrals from the intervention arm compared to usual care was 4.9 (p<0.001; 95 CI 1.7 to 14.7). Conclusion: A brief training session can significantly increase GP referral to smoking cessation services. Trial registration: National Research Register, Department of Health, UK N0261148824 (available online at: http://www.nrr.nhs.uk/ViewDocument.asp?ID  N0261148824)

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. A randomized controlled trial comparing the efficacy of electronic cigarettes and nicotine patches for smoking cessation in pregnant women found no differences between the interventions. However, electronic cigarettes were found to have some benefit when only the data from women who adhered strictly to the trial protocol were analyzed.

The 5:2 diet is a popular intermittent energy restriction method of weight management that awaits further evaluation. We compared the effects of one-off 5:2 instructions with the effects of one-off standard multicomponent weight-management advice; and also examined whether additional behavioural support enhances 5:2 adherence and efficacy compared to one-off instructions. Three hundred adults with obesity were randomised to receive a Standard Brief Advice (SBA) covering diet and physical activity (N = 100); 5:2 self-help instructions (5:2SH) (N = 100); or 5:2SH plus six once-weekly group support sessions (N = 100). Participants were followed up for one year. Adherence to 5:2SH was initially high (74% at 6 weeks), but it declined over time (31% at 6 months and 22% at one year). 5:2SH and SBA achieved similar weight-loss at six months (-1.8kg (SD = 3.5) vs -1.7kg (SD = 4.4); b = 0.23, 95%CI:-0.79-1.27, p = 0.7) and at one year (-1.9kg (SD = 4.9) vs -1.8kg (SD = 5.7), b = 0.20, 95%CI:-1.21-1.60, p = 0.79), with 18% vs 15% participants losing ≥5% of their body weight with 5:2SH and SBA, respectively at one year (RR = 0.83, 95%CI:0.44-1.54, p = 0.55). Both interventions received positive ratings, but 5:2SH ratings were significantly higher. 5:2SH had no negative effect on fat and fiber intake and physical activity compared to SBA. Compared to 5:2SH, 5:2G generated a greater weight loss at 6 weeks (-2.3kg vs -1.5kg; b = 0.74, 95%CI:1.37-0.11, p = 0.02), but by one year, the difference was no longer significant (-2.6kg vs -1.9kg, p = 0.37; ≥5% body weight loss 28% vs 18%, p = 0.10). Simple 5:2 advice and multicomponent weight management advice generated similar modest results. The 5:2 diet did not undermine other health behaviours, and it received more favourable ratings. Adding initial group support enhanced 5:2 adherence and effects, but the impact diminished over time. Health professionals who provide brief weight management advice may consider including the 5:2 advice as an option. ISRCTN registry (ISRCTN79408248).

In a randomized trial involving 886 smokers, e-cigarettes were more effective than nicotine-replacement therapy with respect to the 1-year abstinence rate (18% vs. 10%). Throat or mouth irritation was more common in the e-cigarette group, and nausea was more common in the nicotine-replacement group.

Varenicline and combination nicotine replacement treatment (cNRT) have been recommended as the most effective pharmacotherapies, with equal abstinence rate for smoking cessation in a network meta-analysis of randomized trials, but data from real-world long-term follow-up studies are rare. This study aimed to compare the 12-month sustained abstinence rates of smokers using varenicline versus cNRT in their quit attempt. A total of 3569 smokers were recruited via the Department of Family Medicine outpatient department at Kaohsiung Veteran General Hospital between June 2013 and March 2019. Participants received counseling from a physician and chose either varenicline (N = 2870) or cNRT (N = 699) for smoking cessation. Both varenicline and cNRT users could receive a free 8-week supply and eight clinic visits over 90 days. Participants were followed-up by telephone at 12, 24, and 52 weeks from first visit. The primary outcome measure of the study was self-reported sustained abstinence up to 52 weeks. Varenicline users had a significantly higher sustained abstinence rate at weeks 12-52, adjusted for baseline variables (15.2% vs 10.3%, p = .001; adjusted odds ratio = 1.47, 95% confidence interval: 1.05-2.05). Other significant predictors of 52 weeks sustained abstinence were being male, having a higher income, attending more clinical visits, and have lower nicotine dependence. Varenicline appears to have higher sustained abstinence rates to 52 weeks compared with cNRT, in a smoking cessation clinic where smokers can choose their medication option. Network meta-analysis of randomized trials suggests that varenicline and cNRT are similarly effective for smoking cessation. This study shows that 1-year sustained abstinence rates were significantly higher among smokers using varenicline, compared with smokers using cNRT, when used as part of a structured smoking cessation program. These findings are highly relevant to policy makers and service providers to help determine provision of smoking cessation treatment.

Background Effective and scalable prevention approaches are urgently needed to address the rapidly increasing rates of e-cigarette use among adolescents. School-based eHealth interventions can be an efficient, effective, and economical approach, yet there are none targeting e-cigarettes within Australia. This paper describes the protocol of the OurFutures Vaping Trial which aims to evaluate the efficacy and cost-effectiveness of the first school-based eHealth intervention targeting e-cigarettes in Australia. Methods A two-arm cluster randomised controlled trial will be conducted among Year 7 and 8 students (aged 12–14 years) in 42 secondary schools across New South Wales, Western Australia and Queensland, Australia. Using stratified block randomisation, schools will be assigned to either the OurFutures Vaping Program intervention group or an active control group (health education as usual). The intervention consists of four web-based cartoon lessons and accompanying activities delivered during health education over a four-week period. Whilst primarily focused on e-cigarette use, the program simultaneously addresses tobacco cigarette use. Students will complete online self-report surveys at baseline, post-intervention, 6-, 12-, 24-, and 36-months after baseline. The primary outcome is the uptake of e-cigarette use at 12-month follow-up. Secondary outcomes include the uptake of tobacco smoking, frequency/quantity of e-cigarettes use and tobacco smoking, intentions to use e-cigarettes/tobacco cigarettes, knowledge about e-cigarettes/tobacco cigarettes, motives and attitudes relating to e-cigarettes, self-efficacy to resist peer pressure and refuse e-cigarettes, mental health, quality of life, and resource utilisation. Generalized mixed effects regression will investigate whether receiving the intervention reduces the likelihood of primary and secondary outcomes. Cost-effectiveness and the effect on primary and secondary outcomes will also be examined over the longer-term. Discussion If effective, the intervention will be readily accessible to schools via the OurFutures platform and has the potential to make substantial health and economic impact. Without such intervention, young Australians will be the first generation to use nicotine at higher rates than previous generations, thereby undoing decades of effective tobacco control. Trial registration The trial has been prospectively registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12623000022662; date registered: 10/01/2023).