Clinical study protocol on electronic cigarettes and nicotine pouches for smoking cessation in Pakistan: a randomized controlled trial
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SUBMITTER: Hameed A
PROVIDER: S-EPMC10759381 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
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Project description:IntroductionNicotine-replacement therapy (NRT) and electronic cigarettes (e-cigarettes) have been frequently used for smoking cessation. The aim of this review is to investigate the effectiveness and safety of e-cigarettes versus NRT for smoking cessation.MethodsWe searched PubMed, EMBASE, the Cochrane Library from inception to 10 October 2021. We included randomized controlled trials (RCTs) comparing e-cigarettes versus NRT for smoking cessation. Two authors independently screened titles, abstracts and full texts for eligibility. Paired authors extracted data, assessed risk of bias, and used GRADE (Grades of Recommendation, Assessment, Development, and Evaluation) to rate the certainty of evidence.ResultsThe study included five RCTs with 1748 participants. The meta-analysis suggested the e-cigarettes versus NRT increased the ≥6 months continuous abstinence rate (RR=1.67; 95% CI: 1.21-2.28; 55 more per 1000 participants, low certainty), and 7-day point abstinence rate at ≥6 months follow-up (RR=1.43; 95% CI: 1.19-1.72; 84 more per 1000, low certainty). However, we found no evidence that e-cigarettes versus NRT increased 3-6 months continuous abstinence rate (RR=1.07; 95% CI: 0.73-1.57; 10 more per 1000, very low certainty) and <3 months continuous abstinence rate (RR=1.20; 95% CI: 0.90-1.60; 54 more per 1000, low certainty); similar results were found at <3 months follow-up (RR=1.19; 95% CI: 0.92-1.54; 55 more per 1000, very low certainty) and 3-6 months follow-up in 7-day point abstinence rate (RR=1.01; 95% CI: 0.70-1.44; 2 more per 1000, very low certainty). The adverse events were not significant between e-cigarettes and NRT other than throat irritation (RR=1.27; 95% CI: 1.13-1.42; 118 more per 1000, low certainty).ConclusionsE-cigarettes appeared to be superior to NRT in ≥6 months continuous abstinence rate and 7-day point abstinence rate. At short-term duration, we found no evidence that e-cigarettes compared to NRT increased the <6 months continuous abstinence rate and 7-day point abstinence rate.
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Project description:The use of nicotine replacement therapy before quitting smoking is called nicotine preloading. Standard smoking cessation protocols suggest commencing nicotine replacement therapy only on the first day of quitting smoking (quit day) aiming to reduce withdrawal symptoms and craving. However, other, more successful smoking cessation pharmacotherapies are used prior to the quit day as well as after. Nicotine preloading could improve quit rates by reducing satisfaction from smoking prior to quitting and breaking the association between smoking and reward. A systematic literature review suggests that evidence for the effectiveness of preloading is inconclusive and further trials are needed.This is a study protocol for a multicenter, non-blinded, randomized controlled trial based in the United Kingdom, enrolling 1786 smokers who want to quit, funded by the National Institute for Health Research, Health Technology Assessment program, and sponsored by the University of Oxford. Participants will primarily be recruited through general practices and smoking cessation clinics, and randomized (1:1) either to use 21 mg nicotine patches, or not, for four weeks before quitting, whilst smoking as normal. All participants will be referred to receive standard smoking cessation service support. Follow-ups will take place at one week, four weeks, six months and 12 months after quit day. The primary outcome will be prolonged, biochemically verified six-month abstinence. Additional outcomes will include point prevalence abstinence and abstinence of four-week and 12-month duration, side effects, costs of treatment, and markers of potential mediators and moderators of the preloading effect.This large trial will add substantially to evidence on the effectiveness of nicotine preloading, but also on its cost effectiveness and potential mediators, which have not been investigated in detail previously. A range of recruitment strategies have been considered to try and compensate for any challenges encountered in recruiting the large sample, and the multicentre design means that knowledge can be shared between recruitment teams. The pragmatic study design means that results will give a realistic estimate of the success of the intervention if it were to be rolled out as part of standard smoking cessation service practice.Current Controlled Trials ISRCTN33031001. Registered 27 April 2012.
| S-EPMC4223826 | biostudies-other
Project description:Stop smoking it is often associated to weight gain that is one of the most important causes for relapse. This is the first study to describe long-term changes in body weight in smokers invited to quit or reduce smoking by switching to ECs. Conventional cigarettes consumption and body weight were measured prospectively in a randomized controlled trial of smokers invited to switch to ECs. Post cessation weight changes from baseline at week-12, -24 and -52 were compared among 1) high, medium and zero nicotine strength products and 2) pooled continuous smoking failure, smoking reduction and abstinence phenotypes. Saliva cotinine levels and appetite levels were also measured. No significant changes in body weight were observed among high, medium and zero nicotine strength products. Differences among continuous smoking phenotypes were significant only at week-12 (p = 0.010) and week-24 (p = 0.012) with quitters gaining 2.4{plus minus}4.3 Kg and 2.9{plus minus}4.4 Kg respectively. However, weight gain at week-52 (1.5{plus minus}5.0 Kg) was no longer significant compared to Failures and Reducers. No confounding factors could explain the significant changes in body weight. Smokers who quit smoking by switching to ECs may limit their post-cessation weight gain, with substantial reversal in weight gain being manifest at late time points.
| S-EPMC4700433 | biostudies-other
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| S-EPMC7427392 | biostudies-literature
Project description:IntroductionCigarette smoking by surgical patients is associated with increased complications. E-cigarettes have emerged as a potential smoking cessation tool. We sought to determine the feasibility and acceptability of e-cigarettes, compared to nicotine patch, for perioperative smoking cessation in veterans.MethodsPreoperative patients were randomized to either the nicotine patch group (n = 10) or the e-cigarette group (n = 20). Both groups were given a free 6-week supply in a tapering dose. All patients received brief counseling, a brochure on perioperative smoking cessation, and referral to the California Smokers' Helpline. The primary outcome was rate of smoking cessation on day of surgery confirmed by exhaled carbon monoxide. Secondary outcomes included smoking habits, pulmonary function, adverse events, and satisfaction with the products on day of surgery and at 8-weeks follow-up.ResultsBiochemically verified smoking cessation on day of surgery was similar in both groups. Change in forced expiratory volume in one second (FEV1) was 592 ml greater in the e-cigarette group (95% CI [153-1,031] ml, p = 0.01) and change in forced expiratory volume in one second to forced vital capacity ratio (FEV1/FVC ratio) was 40.1% greater in the e-cigarette group (95% CI [18.2%-78.4%], p = 0.04). Satisfaction with the product was similar in both groups.DiscussionE-cigarettes are a feasible tool for perioperative smoking cessation in veterans with quit rates comparable to nicotine replacement patch. Spirometry appears to be improved 8-weeks after initiating e-cigarettes compared to nicotine patch, possibly due to worse baseline spirometry and more smoking reduction in the e-cigarette group. An adequately powered study is recommended to determine if these results can be duplicated.
| S-EPMC6166615 | biostudies-literature