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Nicotine delivery, tolerability and reduction of smoking urge in smokers following short-term use of one brand of electronic cigarettes.

ABSTRACT: This randomized, partially single-blinded, 6-period crossover clinical study of adult smokers compared the nicotine pharmacokinetics, impacts on smoking urge and tolerability of various formulations of one brand of e-cigarettes with that of a tobacco cigarette.Five e-cigarettes with different e-liquid formulations containing 1.6 % and 2.4 % nicotine and a conventional tobacco cigarette were randomized among 24 subjects under two exposure sessions consisting of a 30-min controlled and a one-hour ad lib use period to assess plasma nicotine levels, impacts on smoking urge and adverse events. The 30-min controlled use session comprised an intensive use of the e-cigarettes with a total of 50 puffs taken every 30 s for comparison to a single conventional cigarette having a typical machine-measured nicotine yield (~0.8 mg). Ad lib product use conditions provided insight into more naturalistic product use behaviors and their accompanying smoking urge reductions. Adverse events (AEs) were assessed by the Principal Investigator.Significant (p?

SUBMITTER: D'Ruiz CD

PROVIDER: S-EPMC4588874 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Nicotine delivery, tolerability and reduction of smoking urge in smokers following short-term use of one brand of electronic cigarettes.

D'Ruiz Carl D CD Graff Donald W DW Yan X Sherwin XS

BMC public health 20150930

<h4>Background</h4>This randomized, partially single-blinded, 6-period crossover clinical study of adult smokers compared the nicotine pharmacokinetics, impacts on smoking urge and tolerability of various formulations of one brand of e-cigarettes with that of a tobacco cigarette.<h4>Methods</h4>Five e-cigarettes with different e-liquid formulations containing 1.6 % and 2.4 % nicotine and a conventional tobacco cigarette were randomized among 24 subjects under two exposure sessions consisting of ...[more]

PMID: 26424091

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Project description:Electronic cigarette (EC) use is growing dramatically with use highest among young adults and current smokers. One of the most common reasons for using ECs is interest in quitting or reducing cigarettes per day (CPD); however there are few randomized controlled trials (RCT) on the effect of ECs on smoking abstinence and reduction.We conducted a two-arm; double-blind RCT. Subjects were randomized to receive 3-weeks of either disposable 4.5% nicotine EC (intervention) or placebo EC. The primary outcome was self-reported reduction of at least 50% in the number of CPDs smoked at week 3 (end of treatment) compared to baseline. Study subjects (n = 99) were young adult (21-35), current smokers (smoked ? 10 CPDs) living in NYC.Compared with baseline, a significant reduction in CPDs was observed at both study time periods (1 and 3 weeks) for intervention (P < .001) and placebo (P < .001) groups. Between-group analyses showed significantly fewer CPDs in the intervention group compared to the placebo group at week 3 (P = .03), but not at any other follow-up periods. The logistic regression analysis showed that using a greater number of ECs, treatment condition and higher baseline readiness to quit were significantly associated with achieving at least 50% reduction in CPDs at the end of treatment.A diverse young adult sample of current everyday smokers, who were not ready to quit, was able to reduce smoking with the help of ECs. Further study is needed to establish the role of both placebo and nicotine containing ECs in increasing both reduction and subsequent cessation.Despite the critical need for well-designed clinical trials on the effect of ECs on cessation and cigarette reduction, the majority of studies have been observational or noncomparative intervention designs. Only three RCTs studying ECs as a cessation or reduction intervention have been published, and none were conducted in the United States. The current study adds knowledge to current literature on the feasibility of using ECs to aid smoking reduction among young smokers in US urban populations.

Project description:Background The success of pharmacotherapies for smoking cessation in real-life remains limited, with a significant number of long-term relapses. Despite first promising results, the duration of the effectiveness of electronic cigarettes is still unknown. Our objective was to assess the duration of the effectiveness of electronic cigarettes on smoking cessation and reduction in daily smokers. Methods The databases EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), ClinicalTrials.gov and PUBMED were consulted until March 23, 2022. We selected only randomized controlled trials with daily adult smokers. The intervention was the nicotinic electronic cigarette vs. non-nicotine electronic cigarette or other validated pharmacotherapies (varenicline, bupropion and nicotine replacement therapy). The minimum duration of the intervention was 3 months, with a follow-up of at least 6 months. Two independent reviewers used the PRISMA guidelines. The primary endpoint was smoking cessation at the end of the intervention and follow-up periods confirmed by a reduction in expired CO < 10 ppm. The reduction was defined as at least 50% of the initial consumption or by a decrease of daily mean cigarette consumption at the end of the intervention and follow-up periods. Results Abstinence at the end of the intervention and follow-up periods was significantly higher in the nicotine electronic cigarette group, compared to nicotine replacement therapy (NRT) [respectively: RR: 1.37 (CI 95%: 1.32–2.93) and RR: 1.49 (CI 95%: 1.14–1.95)] and to the non-nicotine electronic cigarette condition [respectively: RR: 1.97 (CI 95%: 1.18–2.68) and RR: 1.66 (CI 95%: 1.01–2.73)]. With regard to smoking reduction, the electronic cigarette with nicotine is significantly more effective than NRT at the end of the intervention and follow-up periods [respectively RR: 1.48 (CI 95%: 1.04–2.10) and RR: 1.47 (CI 95%: 1.18–1.82)] and non-nicotine electronic cigarette in the long term [RR: 1.31 (CI 95%: 1.02–1.68)]. Conclusions This meta-analysis shows the duration of the effectiveness of the nicotine electronic cigarette vs. non-nicotine electronic cigarette and NRT on smoking cessation and reduction. There are still uncertainties about the risks of its long-term use and its potential role as a gateway into smoking, particularly among young people.

Project description:IntroductionMost pregnant smokers report abruptly reducing their cigarettes per day (CPD) by ~50% after learning of pregnancy and making further smaller reductions over the remainder of their pregnancy. Laboratory and naturalistic studies with non-pregnant smokers have found that these types of reductions often lead to changes in smoking topography (i.e., changes in smoking intensity to maintain a desired blood-nicotine level). If pregnant women smoke more intensely, they may expose themselves and their offspring to similar levels of toxicants despite reporting reductions in CPD.MethodsPregnant and non-pregnant female smokers (n = 20 and 89, respectively) participated. At the experimental session, after biochemical confirmation of acute abstinence, participants smoked one usual brand cigarette ad lib through a Borgwaldt CReSS Desktop Smoking Topography device. Carbon monoxide (CO) and measures of nicotine withdrawal, craving, and reinforcement derived from smoking were also collected.ResultsThe two groups did not differ on demographic or smoking characteristics at screening, except nicotine metabolism rate, which as expected, was faster in pregnant smokers. Analyses suggest that none of the smoking topography parameters differed between pregnant and non-pregnant smokers, although pregnant smokers had a significantly smaller CO boost. Both groups reported similar levels of relief of withdrawal and craving after smoking, but other subjective effects suggest that pregnant smokers find smoking less reinforcing than non-pregnant smokers.ConclusionsPregnant smokers do not smoke cigarettes differently than non-pregnant women, but appear to find smoking comparatively less pleasurable.ImplicationsThis is the first study to assess smoking topography in pregnant women. Pregnant women appear to be at increased risk for smoking cigarettes with more intensity because of (1) their tendency to make significant abrupt reductions in the number of cigarettes they smoke each day after learning of pregnancy and (2) an increase in nicotine metabolism induced by pregnancy. Despite these changes, the present results suggest that pregnant women do not smoke cigarettes more intensely or in a way that causes more toxicant exposure, perhaps due to a reportedly less pleasurable smoking experience.

Project description:Background and aimsIn 2017, the US Food and Drug Administration (FDA) proposed to reduce nicotine in cigarettes to minimally or non-addictive levels. This study qualitatively explored perceptions of nicotine and addiction, both independently and in response to messages communicating about nicotine reduction.DesignQualitative study using focus groups. Participants described their perceptions of nicotine and addiction and their responses to messages about the nicotine reduction.SettingAtlanta, GA and San Francisco, CA, USA. Semi-structured focus groups were conducted virtually in Spring 2020.ParticipantsExclusive smokers (n = 27), dual users (of cigarettes and electronic cigarettes) (n = 25), former smokers (n = 32) and young adult non-smokers (n = 31).MeasurementInductive thematic analysis of transcripts was conducted, and results were compared across smoking status groups.FindingsParticipants across all smoking status groups associated nicotine with tobacco products, but consistently misperceived that nicotine caused disease. Perceptions of addiction were largely negative and varied by smoking status. Experienced smokers (exclusive smokers, former smokers and dual users) differentiated tobacco use from other addictions and minimized their own experiences of addiction. Perceptions of addiction across experienced smokers included not only the chemical properties of nicotine, but also the behavioral aspects of tobacco use, including oral fixation, having a smoking routine and response to internal and external cues. In response to messages, many believed that removing the nicotine would not make cigarettes less addictive because of the multi-factorial nature of smoking addiction that includes non-pharmacological cues.ConclusionsPerceptions of nicotine and addiction among non-smokers, former smokers, exclusive smokers and dual users of cigarettes and e-cigarettes vary based on smoking status, but there is a common tendency to believe that nicotine is addictive, that addiction results from more than just nicotine, and that very low nicotine cigarettes will not necessarily reduce the addictiveness of cigarettes.

Dataset Information

Nicotine delivery, tolerability and reduction of smoking urge in smokers following short-term use of one brand of electronic cigarettes.

Publications

Nicotine delivery, tolerability and reduction of smoking urge in smokers following short-term use of one brand of electronic cigarettes.

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