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This study is part of a programmatic effort evaluating the effects of reducing nicotine content of cigarettes to minimally addictive levels. To examine whether very low-nicotine-content (VLNC) cigarettes decrease smoking rates and dependence severity among smokers with psychiatric disorders or socioeconomic disadvantage. These 3 randomized clinical trials were performed at the University of Vermont, Brown University, and Johns Hopkins University between October 2016 and September 2019. Participants received 12 weeks of exposure to study cigarettes with nicotine content ranging from levels representative of commercial cigarettes (15.8 mg nicotine/g tobacco) to less than a hypothesized addiction threshold (2.4 mg/g and 0.4 mg/g). Daily smokers from 3 at-risk populations participated: individuals with affective disorders, exemplifying smokers with mental illness; individuals with opioid use disorder, exemplifying smokers with substance use disorders; and women with high school educations or less, exemplifying smokers with socioeconomic disadvantage. Data were analyzed from September 2019 to July 2020. Random assignment to 1 of 3 study cigarettes provided weekly at no cost for 12 weeks. The primary outcome was between-group differences in mean total cigarettes smoked daily (CPD) during week 12; secondary outcomes included CPD for study and nonstudy cigarettes and dependence severity across weeks analyzed using analysis of covariance, random coefficients growth modeling, or repeated measures analysis of variance. A total of 775 participants were included (mean [SD] age, 35.59 [11.05] years; 551 [71.10%] women [owing to 1 population being exclusively women]); participants smoked a mean (SD) of 17.79 (9.18) CPD at study intake. A total of 286 participants were randomized to 0.4 mg/g, 235 participants were randomized to 2.4 mg/g, and 254 participants were randomized to 15.8 mg/g. Participants randomized to VLNC cigarettes had decreased mean [SEM] total CPD during week 12 across populations (Cohen d = 0.61; P < .001). At week 12, mean (SEM) CPD decreased to 17.96 (0.98) CPD in the 0.4 mg/g group and to 19.53 (1.07) CPD in the 2.4 mg/g group, both of which were significantly different from the 15.8 mg/g group (25.08 [1.08] CPD at week 12) but not each other (0.4 mg/g adjusted mean difference: -7.54 [95%CI, -9.51 to -5.57]; 2.4 mg/g adjusted mean difference: -5.34 [95% CI, 7.41 to -3.26]). Several secondary outcomes differed across populations randomized to VLNCs, including mean total CPD across weeks, with linear trends lower in participants receiving 0.4 mg/g (-0.28 [95%CI, -0.39 to -0.18]; P < .001) and 2.4 mg/g (-0.13 [95%CI, -0.25 to -0.01]; P < .001) doses compared with those receiving the 15.8 mg/g dose (0.30 [95% CI, 0.19 to 0.41]). Fagerström Test of Nicotine Dependence mean total scores were significantly lower in participants who received VLNCs (Cohen d = 0.12; P < .001), with those who received the 0.4 mg/g dose (mean [SD] score, 3.99 [0.06]; P < .001 vs 15.8 mg/g) or 2.4 mg/g dose (mean [SD] score, 4.07 [0.06]; P = .01 vs 15.8 mg/g) differing from those who received the 15.8 mg/g dose (mean [SD] score, 4.31 [0.06]) but not from each other. These findings demonstrate that decreasing the nicotine content of cigarettes to very low levels reduced smoking rate and nicotine-dependence severity in these high-risk populations, effects that may facilitate successful cessation. ClinicalTrials.gov Identifiers: NCT02232737, NCT02250664, NCT02250534.

Background Smoking rates in the UK have declined steadily over the past decades, masking considerable inequalities, as little change has been observed among people with a mental health condition. This trial sought to assess the feasibility and acceptability of supplying an electronic cigarette (e-cigarette) starter kit for smoking cessation as an adjunct to usual care for smoking cessation, to smokers with a mental health condition treated in the community, to inform a future effectiveness trial. Methods This randomised controlled feasibility trial, conducted March-December 2022, compared the intervention (e-cigarette starter kit with a corresponding information leaflet and demonstration with Very Brief Advice) with a ‘usual care’ control at 1-month follow-up. Participants were ≥ 18 years, receiving treatment for any mental health condition in primary or secondary care in three Mental Health Trusts in Yorkshire and one in London, UK. They were also willing to address their smoking through either cessation or reduction of cigarette consumption. The agreed primary outcome measure was feasibility (consent ~ 15% of eligible participants; attrition rate < 30%). Acceptability, validated sustained abstinence and ≥ 50% cigarette consumption reduction at 1-month, were also evaluated and qualitative interviews conducted to further explore acceptability in this population. Results Feasibility targets were partially met; of 201 eligible participants, 43 (mean age = 45.2, SD = 12.7; 39.5% female) were recruited (21.4%) and randomised (intervention:48.8%, n  = 21; control:51.2%, n  = 22). Attrition rate was 37.2% at 1-month follow-up and was higher (45.5%) in the control group. At follow-up ( n  = 27), 93.3% ( n  = 14) in the intervention group and 25.0% ( n  = 3) in the control group reported e-cigarette use. The intervention was well received with minimal negative effects. In intention-to-treat analysis, validated sustained abstinence at 1-month was 2/21 (9.5%) and 0/22 (0%) and at least 50% reduction in cigarette consumption 13/21 (61.9%) and 3/22 (13.6%), for the intervention and control group, respectively. Qualitative analysis of participant interviews ( N  = 5) showed the intervention was broadly acceptable, but they also highlighted areas of improvements for the intervention and trial delivery. Conclusions Offering an e-cigarette starter kit to smokers with a mental health condition treated in the community was acceptable and largely feasible, with harm reduction outcomes (i.e. switching from cigarette smoking to e-cigarette use and substantial reduction in cigarette consumption) favouring the intervention. The findings of the study will be used to help inform the design of a main trial. Trial Registration Registry: ISRCTN. Registration number: ISRCTN17691451. Date of registration: 30/09/2021

RationaleThe degree to which the EU version of Juul with 20 mg/ml nicotine (Juul EU) delivers nicotine to users is likely to determine its treatment potential.ObjectivesTo compare the pharmacokinetic profile and user ratings of Juul EU, Juul US (59 mg/ml nicotine), cigarettes and other e-cigarette (EC) products.MethodsIn a within-subjects crossover design, 18 vapers used, at separate sessions, their own brand cigarette (OBC), Juul US and Juul EU for 5 min ad libitum, after overnight abstinence. Seven of the participants also tested eight other EC previously. Blood samples were taken at baseline and 2, 4, 6, 8, 10 and 30 min after initiating product use. Products were rated on a range of characteristics.ResultsJuul EU delivered less nicotine than OBC (t(13) = −4.64 p < .001) and than Juul US (t(13) = −6.40, p < .001): AUC0 ≥ 30 77.3, 324.8 and 355.9, respectively. Maximum nicotine concentration (Cmax) was also much lower for Juul EU than Juul US (z = −3.59, p < .001): Cmax 3.8 ng/ml vs 21.1 ng/ml, respectively. Juul EU was perceived to relieve urges to smoke less than Juul US (z = −2.29, p = .022) and to provide less nicotine (z = −2.57. p = 0.010). Juul EU delivered less nicotine than refillable EC (Cmax: t(6) = 3.02, p = 0.023; AUC0 ≥ 30: z = −2.20, p = 0.028) and also less than cig-a-like EC, though the difference did not reach significance (Cmax: t(6) = 2.49, p = 0.047; AUC0 ≥ 30: z = −1.99, p = 0.046). Subjective ratings of Juul EU and other EC products were similar.ConclusionsJuul EU delivers much less nicotine to users than Juul US, and also less than refillable EC products. It may thus have more limited potential to help smokers quit.

BackgroundResearch is needed to understand the acceptability of electronic nicotine delivery systems (ENDS) as a smoking reduction aid. This study examines the acceptability of ENDS by liquid nicotine concentration and flavour among people who smoke using ENDS to reduce their smoking.MethodsPeople who smoke cigarettes but were naïve to ENDS participated in a double-blind randomised controlled trial to reduce conventional cigarette smoking. Participants were randomised to either a control cigarette substitute (CS) or one of three ENDS groups; 0 mg/mL, 8 mg/mL or 36 mg/mL nicotine concentration. ENDS flavour was chosen by the participant (tobacco or menthol). Participants reported their CS, ENDS and cigarettes per day (CPD) from the past 7 days at 1-month, 3-month and 6-month follow-up visits. Participants also reported side effects and measures of satisfaction, psychological reward, aversion and craving relief. Outcome variables were modelled using linear mixed effects by the following groups: liquid nicotine concentration, flavour and a flavour-nicotine concentration interaction.ResultsParticipants (n=520) were 41.2% male, 67.3% white, had a mean age of 46.2 years and smoked a mean of 18.6 CPD (SD=7.74) at baseline. All flavour and concentration groups decreased CPD from baseline to all follow-up visits with the 36 mg/mL experiencing the greatest reduction, compared with the 0 mg/mL and 8 mg/mL groups. All groups except the 36 mg/mL group decreased their product use over time. The use of menthol flavour was associated with fewer side effects at 3 months (p=0.02) and lesser aversion at 1 month (p=0.03) compared with tobacco-flavoured ENDS. The 36 mg/mL group experienced the greatest craving relief and greatest aversion compared with other groups.ConclusionsBoth nicotine concentration and flavour appear to have independent, as well as interactive, effects that influence ENDS acceptability among people who use cigarettes.

Smartphone applications (apps) for smoking cessation are becoming increasingly available, but their efficacy remains to be demonstrated. We conducted a pilot study of SmokeBeat, a novel app designed for use with smartwatches and wristbands. SmokeBeat is powered by a data analytics software platform that processes information from the sensors embedded in wearables. It relies on an original algorithm to identify in real time the hand-to-mouth gestures that characterize smoking a cigarette. We examined whether merely monitoring and notifying smokers on smoking episodes in real time via the SmokeBeat app would lead to reduction in smoking. Forty smokers (9 women and 31 men) who expressed a wish to reduce or quit smoking were randomly assigned to using the SmokeBeat app for 30 days or to a wait-list control group. All participants completed questionnaires at baseline and at the end of the study, including their level of smoking. Smokers in the experimental condition were notified whenever the SmokeBeat system detected a smoking episode and were asked to confirm or deny it. The SmokeBeat algorithm correctly detected over 80% of the smoking episodes and produced very few false alarms. According to both self-report and detection of smoking episodes by the SmokeBeat system, smokers in the experimental condition showed a significant decline in smoking rate over the 30-day trial (p < .001). There was no change in the smoking rate of the control group. These preliminary results suggest that automatic monitoring of smoking episodes and alerting the smoker in real time may facilitate smoking reduction in motivated smokers. Raising the awareness of smokers to the act of smoking in real time, as the SmokeBeat app is able to do, can counter the automaticity of the smoking habit. Bringing smoking under conscious awareness may benefit smokers who are motivated to reduce or quit smoking to gain better control of their smoking behavior and reduce cigarette intake.

IntroductionNicotine replacement therapy (NRT) helps pregnant women quit smoking. Usual National Health Service (NHS) cessation care in pregnancy starts only after women stop smoking and comprises behavioural support and NRT. NRT is stopped if women restart smoking. We hypothesised that NRT would have a bigger effect on cessation in pregnancy if used: (1) to reduce smoking before quitting (‘preloading’), (2) during brief smoking lapses after quitting and (3) to help those who cannot stop smoking, to reduce instead.Methods and analysisA two-arm parallel group, open-label, multicentre, assessor-blind randomised controlled trial. Participants are recruited at hospital antenatal clinics and other NHS settings throughout England and Wales or via social media advertising. Those enrolled are in antenatal care, <25 weeks’ gestation, smoke ≥5 daily cigarettes; accept referral for NHS stop smoking support and agree to set quit dates, try NRT and vape less than daily. Participants are randomised to: (1) usual care (UC) or (2) UC plus an intervention combining (1) NRT for preloading, (2) counselling to continue NRT during brief smoking lapses, and for those who cannot stop, (3) NRT to reduce smoking. The primary outcome is biochemically validated, smoking abstinence from 6 weeks after randomisation to 36 weeks gestation. Secondary outcomes include birth outcomes and cost per quality-adjusted life year. Questionnaires collect follow-up data augmented by medical record information. We anticipate quit rates of 10% and 15.9% in the control and intervention groups (OR=1.7). By recruiting 1430 participants, smoking, nicotine and pregnancy 3 should have 90% power (alpha=5%) to detect this effect. We will use the Economics of Smoking in Pregnancy model to estimate cost-effectiveness.Ethics and disseminationEthics approval was granted by the West Midlands—Coventry & Warwickshire Research Ethics Committee (REC reference: 21/WM/0172; Protocol number 21001; IRAS Project ID: 291236). Written informed consent will be obtained from all participants. Findings will be disseminated to the public, funders, relevant practice and policy representatives and other researchers.Trial registration numberISRCTN84798566.

Abstract Aims To compare the efficacy of brief advice about cut-down-to-quit (CDTQ) with that of brief advice about quit immediately (QI), as delivered by trained volunteers, without the use of pharmacological therapy, to outreach-recruited Chinese smokers in Hong Kong who intend to quit smoking. Methods Smokers (N = 1077) who enrolled in the Quit and Win Contest 2014 and intended to quit or reduce smoking were randomized in participation sessions to CDTQ (n = 559) and QI (n = 518) groups. Subjects in the CDTQ group received brief advice and a card about smoking reduction. Subjects in the QI group received brief advice and a leaflet about quitting smoking. All received a smoking cessation booklet and corresponding CDTQ or QI brief telephone advice at intervals of 1 week, 1 month, or 2 months. The primary outcomes were self-reported 7-day point prevalence abstinence (PPA) at the 3-month and 6-month follow-ups. The secondary outcomes included abstinence rate as validated by biochemical tests, smoking reduction (≥50% reduction from baseline), and quit attempt (QA). The outcome assessors were blinded as to group assignment. Results By intention to treat, the QI and CDTQ groups showed similar results as regards (i) self-reported PPA (10.6% [95% CI 8.1%–13.6%] vs. 9.1% [95% CI 6.9%–11.8%]), (ii) validated abstinence rate (5.6% [3.8%–7.9%] vs. 5.4% [3.6%–7.6%]), and (iii) QA rate (59.2% [53.5%–64.8%] vs. 54.1% [48.7%–59.3%]) at 6-month. However, the CDTQ group showed a significantly higher reduction rate than the QI group (20.9% [CI 17.6%–24.5%] vs. 14.5% [11.6%–17.8%]). The overall intervention adherence was suboptimal (45.4%), particularly in the CDTQ group (42.3%). Self-efficacy as regards quitting of smoking was similar between the groups at 6 months. Conclusions Brief advice on CDTQ and QI had similar short-term PPAs. Longer-term follow-up is needed to understand the latent effect of smoking reduction on abstinence. Implications This is the first randomized controlled trial in ethnic Chinese smokers to evaluate the relative efficacy of brief advice on (a) CDTQ and (b) QI as regards quitting. The two interventions showed similar effects as regards PPA. The findings suggested that brief advice on CDTQ may be as effective as brief advice on QI in smokers recruited in community settings.

Abstract Introduction Smoking prevalence remains high in some vulnerable groups, including those who misuse substances, have a mental illness, are homeless, or are involved with the criminal justice system. E-cigarette use is increasing and may support smoking cessation/reduction. Methods Systematic review of quantitative and qualitative data on the effectiveness of e-cigarettes for smoking cessation/reduction among vulnerable groups. Databases searched were MEDLINE, EMBASE, PsychINFO, CINAHL, ASSIA, ProQuest Dissertations and Theses, and Open Grey. Narrative synthesis of quantitative data and thematic synthesis of qualitative data. Results 2628 records and 46 full texts were screened; 9 studies were identified for inclusion. Due to low quality of evidence, it is uncertain whether e-cigarettes are effective for smoking cessation in vulnerable populations. A moderate quality study suggested that e-cigarettes were as effective as nicotine replacement therapy. Four studies suggested significant smoking reduction; however, three were uncontrolled and had sample sizes below 30. A prospective cohort study found no differences between e-cigarette users and nonusers. No significant adverse events and minimal side effects were identified. Qualitative thematic synthesis revealed barriers and facilitators associated with each component of the COM-B (capability, opportunity, motivation, and behavior) model, including practical barriers; perceptions of effectiveness for cessation/reduction; design features contributing to automatic and reflective motivation; smoking bans facilitating practical opportunity; and social connectedness increasing social opportunity. Conclusion Further research is needed to identify the most appropriate device types for practicality and safety, level of support required in e-cigarette interventions, and to compare e-cigarettes with current best practice smoking cessation support among vulnerable groups. Implications Smoking prevalence among people with mental illness, substance misuse, homelessness, or criminal justice system involvement remains high. E-cigarettes could support cessation. This systematic review found limited quantitative evidence assessing effectiveness. No serious adverse events were identified. Qualitative thematic synthesis revealed barriers and facilitators mapping to each component of the COM-B (capability, opportunity, motivation, and behavior) model, including practical barriers; perceived effectiveness; design features contributing to automatic and reflective motivation; smoking bans facilitating practical opportunity; and social connectedness increasing social opportunity. Further research should consider appropriate devices for practicality and safety, concurrent support, and comparison with best practice smoking cessation support.

ObjectivesTo examine changes in cardiovascular disease (CVD) risk factors, lung function and clinical laboratory markers among people who smoke who used e-cigarettes to reduce their cigarette smoking.DesignFour-arm, parallel-group, double-blind, randomised placebo-controlled trial.SettingTwo sites—Virginia Commonwealth University (Richmond, Virginia, USA) and Penn State University, College of Medicine (Hershey, Pennsylvania, USA).ParticipantsAdults (n=520) aged 21–65 years who smoked at least 10 cigarettes per day, had an expired-air carbon monoxide reading of >9 parts per million at baseline and were interested in reducing their cigarette consumption.InterventionsE-cigarettes with 0, 8 or 36 mg/mL nicotine liquid concentration or a cigarette substitute.Primary outcome measuresCVD risk factors (blood lipids, C-reactive protein, blood pressure, heart rate, waist-to-hip ratio, body mass index and INTERHEART risk score), lung function (spirometry indices, and pulmonary symptoms and functional state using the Clinical Chronic Obstructive Pulmonary Disorder Questionnaire), and other clinical laboratory markers (complete blood count and complete metabolic panel).ResultsAt 6 months, the use of nicotine e-cigarettes caused no significant between-group differences for most measures. However, participants randomised to the 36 mg/mL e-cigarette condition had significantly higher levels of high-density lipoprotein (HDL) (p=0.003 unadjusted, p=0.002 adjusted) and lower levels of low-density lipoprotein (LDL) (p=0.044 adjusted) and cholesterol/HDL ratio (p=0.034 unadjusted, p=0.026 adjusted) compared with the cigarette substitute condition. Also, those in the 36 mg/mL e-cigarette condition had higher HDL levels than those in the 0 mg/mL condition (p=0.016 unadjusted, p=0.019 adjusted).ConclusionsParticipants randomised to the highest nicotine e-cigarette condition showed modest improvements in some measures of blood lipids (eg, increased HDL, and reduced LDL and cholesterol/HDL ratio) as compared with a non-aerosol cigarette substitute among individuals attempting to reduce their cigarette smoking. Future studies of e-cigarettes for smoking cessation would benefit from including these measures to further explore the results found in this study.Trial registration numberNCT02342795.

Background Quitting cigarette smoking can substantially reduce or eliminate the risk of developing numerous chronic diseases. Use of flavored tobacco or nicotine products is commonly cited by adults who smoke cigarettes to be important in helping them reduce or quit smoking. The purpose of this analysis was to understand the association between the levels of use of flavored oral nicotine products and smoking reduction and quitting and how reduction or quitting may differ between predominant users of fruit/other versus mint flavored oral nicotine products after six months of use. Methods Participants were provided with their choice of a variety of forms and flavors of Rogue ® nicotine products (Study Products) over a 6-month actual use period and completed online surveys assessing tobacco, nicotine and Study Product use at Baseline and Months 1, 2, 4, and 6 thereafter. Results Among the 1393 participants at Month 6, 41.4% and 52.5% used predominantly fruit/other or mint Study Product flavors, respectively. Compared to predominant mint users, predominant fruit/other users had greater cigarette reduction (mean reduction: 50.0% vs. 48.4%) and a higher proportion had quit smoking (proportion quit: 15.4% vs. 11.6%) at Month 6. Additionally, 38.8% of predominant fruit/other users and 39.3% of predominant mint users reduced their cigarette consumption by ≥  50% from Baseline. Increased use of fruit/other flavors was independently associated with smoking reduction (8.6% greater reduction per 10 pieces/day; p  < 0.001) and odds of quitting smoking (OR = 1.29 [95% CI: 1.04–1.59] per 10 pieces/day; p  = 0.017). Increased use of mint flavors was independently associated with smoking reduction (7.5% greater reduction per 10 mint pieces/day; p  < 0.001) but not with odds of quitting smoking. Conclusions Increased use of either fruit/other or mint flavored Study Products at Month 6 was associated with significantly increased smoking reduction, whereas only increased use of fruit/other flavors was associated with greater odds of quitting smoking among participants in the study. Trial Registration This study was observational. Participants were not prospectively assigned to one or more health-related interventions and could choose to use or not use the commercially available study products provided during the study. Thus, the study was not registered in a trial database by the Sponsor.