Expired Air Carbon Monoxide Research Articles

Efficacy of Electronic Cigarettes vs Varenicline and Nicotine Chewing Gum as an Aid to Stop Smoking

ImportanceElectronic cigarettes (ECs) are often used by smokers as an aid to stopping smoking, but evidence is limited regarding their efficacy compared with nicotine replacement therapy (NRT), and no evidence is available on how their efficacy compares with that of varenicline.ObjectiveTo evaluate whether ECs are superior to NRT and noninferior to varenicline in helping smokers quit.Design, Setting, and ParticipantsThis was a randomized clinical trial conducted at 7 sites in China and including participants who were smoking at least 10 cigarettes per day and motivated to quit, not using stop-smoking medications or EC, and willing to use any of the study products. Participants were first recruited in May 2021, and data analysis was conducted in December 2022.InterventionsA cartridge-based EC (30 mg/mL nicotine salt for 2 weeks and 50 mg/mL after that), varenicline (0.5 mg, once a day for 3 days; 0.5 mg, twice a day for 4 days; and 1 mg, twice a day, after that), and 2 mg (for smokers of ≤20 cigarettes per day) or 4 mg (>20 cigarettes per day) nicotine chewing gum, all provided for 12 weeks and accompanied by minimal behavioral support (an invitation to join a self-help internet forum).Main Outcomes and MeasuresThe primary outcome was sustained abstinence from smoking at 6 months as validated by an expired-air carbon monoxide reading (<8 parts per million). Participants lost to follow-up were included as nonabstainers.ResultsOf 1068 participants, 357 (33.5%) were female, and the mean (SD) age was 33.9 (3.1) years. A total of 409 (38.3%), 409 (38.3%), and 250 (23.4%) participants were randomized to the EC, varenicline, and NRT arms, respectively. The 6-month biochemically validated abstinence rates were 15.7% (n = 64), 14.2% (n = 58), and 8.8% (n = 22) in the EC, varenicline, and NRT study arms, respectively. The quit rate in the EC arm was noninferior to the varenicline arm (absolute risk reduction, 1.47%; 95% CI, −1.41% to 4.34%) and higher than in the NRT arm (odds ratio, 1.92; 95% CI, 1.15-3.21). Treatment adherence was similar in all study arms during the initial 3 months, but 257 participants (62.8%) in the EC arm were still using ECs at 6 months, with no further use in the 2 other study arms. The most common adverse reactions were throat irritation (32 [7.8%]) and mouth irritation (28 [6.9%]) in the EC arm, nausea (36 [8.8%]) in the varenicline arm, and throat irritation (20 [8.0%]) and mouth irritation (22 [8.8%]) in the NRT arm. No serious adverse events were recorded.Conclusions and RelevanceThe results of this randomized clinical trial found that when all treatments were provided with minimal behavior support, the efficacy of EC was noninferior to varenicline and superior to nicotine chewing gum.Trial RegistrationChinese Clinical Trial Registry: ChiCTR2100048156

Using varenicline in combination with electronic nicotine delivery systems (ENDS)

BackgroundVarenicline is efficacious for smoking cessation, but a return to smokingusually occurs after treatment ends. Electronic nicotine delivery systems (ENDS) may enhance smoking reduction and cessation by providing a behavioral substitute for smoking and may deter smoking in the long term if an individual's nicotine dependence can be transferred to ENDS. The goal of this study was to evaluate varenicline in conjunction with ENDS to promote switching to ENDS. MethodsTwenty-five individuals who smoked cigarettes, interested in switching but not seeking cessation treatment, received ENDS for 13 weeks; during weeks 2–13 they received varenicline. Assessments included self-reported cigarette and ENDS use, expired air carbon monoxide (CO), reward ratings, tolerability/side effects, and dependence measures. ResultsCigarette smoking decreased from 15.6 cigarettes/day (SD=5.6) at baseline to 2.8 cigarettes/day (SD=5.1) at week 13 (paired t(22)=10.24, p<0.0001). 28% of participants were confirmed to be abstinent in the last 4 weeks of treatment. ENDS use remained relatively constant, averaging 11.8 occasions per day (SD=10.6). Cigarette dependence (assessed by time to first use of the day) decreased after introduction of ENDS (paired t(23) = −3.27, p=0.003), and again after the first week of full-dose varenicline (paired t(23) = −4.27, p=0.0003). Dependence on ENDS did not change, starting out lower than cigarettes (paired t(21) = 5.52, p<0.0001), but ending higher (paired t(22) = 2.94, p=0.008). Smoking satisfaction declined markedly, while satisfaction for ENDS remained relatively constant. Treatment tolerability and adherence were high. ConclusionsENDS in combination with varenicline shows promise as a means to reduce dependence on cigarettes and facilitate switching from cigarettes to ENDS.

Smoking reduction using electronic nicotine delivery systems in combination with nicotine skin patches

RationaleElectronic nicotine delivery systems (ENDS) are used by smokers seeking to reduce combustible cigarette (CC) use, but the role of nicotine replacement vs. behavioral and sensory factors is still poorly understood. We hypothesized that providing nicotine from ENDS in addition to nicotine skin patches would promote smoking reduction relative to non-nicotine control ENDS.ObjectivesTo assess the effects on smoking behavior of using nicotine vs. placebo ENDS in smokers using nicotine vs. placebo patches.MethodsNinety-four daily smokers were enrolled in a study that randomly assigned them to receive ENDS with nicotine vs. without nicotine and skin patches with vs. without nicotine. Smoking reduction and cessation were assessed over an 8-week period by self-report and by expired air carbon monoxide (CO) measurements. The primary outcome was defined as reduction in expired air CO.ResultsThe use of nicotine in ENDS led to significant reductions in smoking (ENDS nicotine vs. placebo difference in CO change = −9.2 ppm; 90% CI (−1.5 ppm, −16.9 ppm)) and was highly correlated with reductions in self-reported cigarettes per day (r=0.6). The effect of nicotine in nicotine patches was not statistically significant (patch nicotine vs. placebo difference in CO change = −0.1 ppm; 90% CI (−7.8 ppm, 7.6 ppm)).ConclusionsThe presence of nicotine in ENDS was associated with a large reduction in smoking. Additional studies will be needed to determine whether there may be additive effects of nicotine ENDS and nicotine patches on smoking abstinence.

Systematic review and meta-analysis investigating nicotine, cotinine and carbon monoxide exposures in people who both smoke and use nicotine replacement therapy.

To determine effects of concurrent smoking and nicotine replacement therapy (NRT) use on reported heaviness of smoking, nicotine (cotinine) body fluid and exhaled air carbon monoxide (CO) concentrations. Systematic review and meta-analysis of RCTs, which test interventions permitting concurrent NRT use and smoking and comparing, within participants, outcomes when smoking with those when smoking and using NRT concurrently. Measurements included reported number of cigarettes smoked per day (CPD), body fluid cotinine and expired air CO concentrations. Twenty-nine studies were included in the review. Meta-analysis of nine showed that, compared with when solely smoking, fewer cigarettes were smoked daily when NRT was used (mean difference during concurrent smoking and NRT use, -2.06 CPD [95% CI = -3.06 to -1.07, P < 0.0001]). Meta-analysis of seven studies revealed a non-significant reduction in exhaled CO during concurrent smoking and NRT use (mean difference, -0.58 ppm [95% CI = -2.18 to 1.03, P = 0.48]), but in the three studies that tested NRT used in the lead-up to quitting (i.e. as preloading), a similar reduction in exhaled CO was statistically significant (mean difference, -2.54 ppm CO [95% CI = -4.14 to -0.95, P = 0.002]). Eleven studies reported cotinine concentrations, but meta-analysis was not possible because of data reporting heterogeneity; of these, seven reported lower cotinine concentrations with concurrent NRT use and smoking, four reported no differences, and none reported higher concentrations. People who smoke and also use nicotine replacement therapy report smoking less heavily than people who solely smoke. When nicotine replacement therapy is used in the lead-up to quitting (preloading), this reported smoking reduction has been biochemically confirmed. There is no evidence that concurrent smoking and nicotine replacement therapy use result in greater nicotine exposure than solely smoking.

Assessment of a Text Message–Based Smoking Cessation Intervention for Adult Smokers in China

Successful smoking cessation strategies are an important part of reducing tobacco use. However, providing universal smoking cessation support can be a challenge for most countries because it requires sufficient resources. One way to expand access is to use mobile technologies to provide cessation support. To assess the efficacy of a behavior change theory-based smoking cessation intervention using personalized text messages. This study was a 2-arm double-blind randomized clinical trial conducted in 5 cities in China. Daily or weekly smokers 18 years or older were eligible for inclusion if they owned a mobile phone and used the WeChat social media app. A total of 722 participants were randomized to the intervention or control group between April 1 and July 27, 2021. Intervention group participants received a personalized text message-based smoking cessation intervention that was based on the transtheoretical model and protection motivation theory and developed by this study's investigators. Control group participants received a nonpersonalized text message-based smoking cessation intervention developed by the US National Cancer Institute. Both groups received 1 to 2 text messages per day for 3 months through the app. The primary outcome was the biochemically verified 6-month sustained abstinence rate, defined as the self-report of no smoking of any cigarettes after the designated quit date, which was validated biochemically by an expired air carbon monoxide level of less than 6 ppm at each follow-up point. A total of 722 participants (mean [SD] age, 41.5 [12.7] years; 716 men [99.2%]; all of Chinese ethnicity) were randomly assigned to the intervention group (360 participants) or the control group (362 participants). Biochemically verified continuous abstinence at 6 months was 6.9% in the intervention group and 3.0% in the control group (odds ratio [OR], 2.66; 95% CI, 1.21-5.83). Among smokers with low nicotine dependence, the intervention group had significantly better abstinence rates for most of the indicators after adjusting for covariates (eg, biochemically verified 24-hour point prevalence of abstinence at 1 month: adjusted OR, 2.15; 95% CI, 1.05-4.38). Among smokers with moderate and high nicotine dependence, only the biochemically verified 24-hour point prevalence of abstinence at 6 months was statistically significant (adjusted OR, 4.17; 95% CI, 1.34-3.00). The pattern was similar for quitting intention, and the personalized text message-based intervention was more effective for smokers who had strong quitting intention than for those who had weak quitting intention. In this study, the behavior change theory-based smoking cessation intervention using personalized text messages was more effective than an intervention using nonpersonalized text messages. The intervention was most effective among smokers with low nicotine dependence and strong quitting intention. This study's findings also provide further evidence regarding the potential benefits of mobile health interventions for other behaviors. Chinese Clinical Trial Registry Identifier: ChiCTR2100041942.

Impact of solid fuel usage on respiratory symptoms among reproductive aged women: a cross-sectional study in Sri Lanka

BackgroundWorldwide, around 3 billion people rely on solid fuel for their daily energy needs. Household air pollution secondary to solid fuel burning is a major risk factor for respiratory mobility among vulnerable populations. This study aimed to investigate the respiratory symptoms associated with solid fuel usage, the level of kitchen fuel smoke exposure and its association with respiratory symptoms among reproductive-aged women in Sri Lanka, where most households exclusively use firewood as the primary cooking fuel.MethodsA descriptive cross-sectional study was conducted among 403 reproductive-aged women (15 to 49 years) in the Central Province, Sri Lanka. A structured interviewer-administered questionnaire was used to collect data, and an exposure assessment was done using a breath carbon monoxide monitor.ResultsAfter adjusting for potential confounding factors by the logistic regression models, the odds ratios (OR) of the liquid petroleum gas-only users for at least one respiratory symptom relevant to cough (OR: 0.39; 95% confidence interval [CI]: 0.20–0.78), wheezing (OR: 0.47; 95% [CI]: 0.26–0.87), and dyspnea (OR: 0.44; 95% CI: 0.24–0.84) were significantly lower compared to firewood-only users. The mean of expired air carbon monoxide and estimated carboxyhemoglobin levels of liquid petroleum gas-only users (2.84 ± 2.85 ppm; 1.08 ± 0.46%) were significantly lower than those of firewood-only users (5.27 ± 4.64 ppm; 1.47 ± 0.74%).ConclusionsThe use of firewood increased the risk of respiratory symptoms among reproductive-aged women in Sri Lanka. Health education focused on positive behavioral changes and effective and efficient clean energy policies are recommended to mitigate the risk associated with solid fuel smoke exposure.

Bupropion/zonisamide combination to assist smokers to switch from combustible cigarettes to electronic nicotine delivery systems (ENDS)

IntroductionElectronic nicotine delivery systems (ENDS) may offer a much less harmful alternative to combustible cigarettes (CC) for adult smokers unwilling or unable to relinquish nicotine. However, dual use of CC and ENDS undermines potential harm reduction, and progress needs to be made to assist smokers to switch to ENDS. This study explored the promise of a novel treatment combination of the smoking cessation medication bupropion and an FDA-approved anti-seizure medication, zonisamide, to facilitate switching from CC to ENDS. Both medications have been found to reduce craving for CC and possibly offset each other’s side effects. MethodsTwenty-four smokers participated in a 13-week treatment during which they were provided with ENDS, bupropion and zonisamide. Assessments included CC and ENDS use, expired air carbon monoxide (CO), smoking withdrawal symptoms, reward ratings and tolerability/side effects. Results33% of participants achieved biochemically confirmed, complete CC abstinence by the end of treatment. Those who did not achieve complete abstinence nonetheless showed a 44% reduction in expired air CO. Craving and other withdrawal symptoms were minimal, and CC smoking satisfaction declined markedly, while satisfaction ratings for ENDS increased over time to overtake those of CC. Side effects were generally mild, and adherence to the medication use was excellent. ConclusionsThe use of combination bupropion/zonisamide to facilitate switching from CC to ENDS is a promising approach that merits follow-up randomized controlled trials. Combining short-term medication approaches with long-term nicotine substitution using ENDS may be a promising strategy to help smokers sustain smoking abstinence in the long term.

Tobacco-use behavior and toxicant exposure among current dual users of electronic cigarettes and tobacco cigarettes.

Electronic cigarette (e-cigarette) use continues to grow with most users reporting concurrent cigarette smoking, but few studies have focused on tobacco use and toxicant exposure among naturalistic dual-using populations. This controlled clinical laboratory study examined how dual versus exclusive use of e-cigarettes and cigarettes and no tobacco/nicotine affected behavioral, physiological, and subjective measures among current dual users. Twenty-two participants identifying as cigarette (≥ 10 cigarettes per day [CPD]) and e-cigarette (≥ 3 days/week) users of "cig-a-like" e-cigarettes completed four 5-day outpatient conditions, which differed by their own brand of products used ad libitum: (a) cigarette and e-cigarette (dual), (b) cigarette-only, (c) e-cigarette-only, and (d) no tobacco/nicotine. Primary outcomes included daily tobacco use, expired air carbon monoxide (CO), and urinary cotinine and NNAL. Linear mixed models with pairwise comparisons (Bonferroni corrected) were performed (p < .05). CPD did not differ significantly between dual and cigarette-only use, but e-cigarette use and liquid consumed increased significantly during e-cigarette-only relative to dual use. Relative to dual use, expired air CO did not differ during cigarette-only and was significantly lower during e-cigarette-only use. Urinary cotinine was significantly lower during e-cigarette-only use relative to dual and cigarette-only use, while urinary NNAL did not differ between the nicotine-containing conditions. In summary, among current dual users, e-cigarettes in combination with cigarettes did not reduce CPD relative to exclusive cigarette use or toxicant exposure relative to exclusive use of either product. However, exclusive e-cigarette use did reduce CO and cotinine, highlighting the benefits of cigarette cessation. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Effectiveness of National Residential Smoking Cessation Program.

We aimed to investigate the effectiveness of the Korean national five-day residential smoking cessation program and the factors affecting the long-term smoking cessation of participants. The residential smoking cessation program (2017–2018) recruited smokers with a smoking duration ≥ 20 years and who have attempted to quit smoking more than twice and/or smokers with chronic morbidities. Participants underwent an intensive intervention, including individual psychological therapy, group therapy, medical counseling, and pharmacotherapy. The 6-month continuous abstinence rate (CAR) was assessed via self-reports, the urine cotinine levels, and/or expired-air carbon monoxide levels. Logistic regression was used to analyze the adjusted odds ratio (aOR) to assess factors related to smoking cessation. Overall, 484 participants who completed the residential program and questionnaire were evaluated. The 3- and 6-month CAR were 81.82% and 63.22%, respectively. The aOR of 6-month continuous abstinence was lower among participants with severe nicotine dependence (aOR: 0.46, 95% confidence interval [CI]: 0.26–0.81) and higher among participants with combination therapy of varenicline with short-term nicotine replacement therapy (NRT) (aOR: 1.64, 95% CI: 1.07–2.51), with higher self-efficacy (aOR: 1.97, 95% CI: 1.15–3.37). The residential smoking cessation program was effective. High self-efficacy, combination therapy of varenicline with short-term NRT, and low nicotine dependence were associated with a high 6-month CAR.

Expired Air Carbon Monoxide Testing Is Effective for Preoperative Screening of Cigarette Use in Orthopaedic Patients: A Prospective Pilot Study of 70 Veterans

Introduction: Screening for cigarette use is standard in the orthopedic pre-operative clinic, however traditional biochemical testing methods, including serum and urine cotinine assays, do not differentiate active smoking from nicotine replacement therapy (NRT). In this prospective pilot study, we hypothesize that exhaled carbon monoxide (eCO) testing will be non-inferior to the gold standard serum cotinine (SC) test in screening for pre-operative cigarette use, will differentiate active smoking from NRT, and will allow for substantial cost savings in a clinic setting. Methods: Adult orthopaedic veterans indicated for elective surgery at our institution were offered inclusion. Self-reported smoking status (SRS), eCO and SC levels were obtained preoperatively. An eCO level of &gt;6 parts per million and a SC level &gt;3 ng/ml were considered positive for recent cigarette use. Agreement between SRS, eCO levels and SC levels, and eCO level test-retest reliability were evaluated. Results: Of the 55 patients enrolled into the study, 4 were self-reported Current Smokers and 51 were self-reported Ex-Smokers or Non-Smokers. Combining SRS with eCO levels as a screening tool for recent cigarette use yielded a sensitivity of 100%, a specificity of 98%, a positive predictive value of 95% and a negative predictive value of 100%. eCO testing differentiated NRT from cigarette use in all non-smoking patients. Test-retest reliability for eCO levels showed perfect agreement for 16 patients that had two or more eCO levels pre-operatively. Conclusion: Exhaled CO testing is as effective as SC testing but can differentiate active smoking from NRT, while maintaining a high level of accuracy and reliability when combined with SRS as a screening tool.

Assessing the efficacy and impact of a personalised smoking cessation intervention among type 2 diabetic smokers: study protocol for an open-label randomised controlled trial (DISCGO-RCT)

IntroductionFew studies have assessed the efficacy of smoking cessation interventions in individuals with type 2 diabetes, but interventions adapted to the specific needs of this population are warranted. The aim...

Expired Air Carbon Monoxide Levels as a Marker of Passive Smoking In Pregnant Women

Background and Aim: Smoking directly or indirectly has serious impact on health of an individual. During smoking various chemicals and toxic substances are released into the air such as nicotine, carbon monoxide which can be inhaled by the people nearby indirectly. Pregnant mothers may passively inhale carbonmonoxidewhen exposed to such environment. Maternal Carbon monoxide passes through placenta and enters foetalblood combine with foetalhaemoglobin forming foetal carboxy haemoglobin. Foetal carboxy haemoglobin in turn makes oxygen unavailableto foetal tissues which could be the reason for various poor outcomes in unborn foetus such as low birth weight, intra uterine growth retardation with higher rates of perinatal mortality. This study is aimed at measuring the expired air carbon monoxide levels in passively smoking pregnant women that can be correlated with exposure to passive smoking. Method and Materials: 100 antenatal women of gestational age between 26 to 34 weeks with and without exposure to passive smoking were measured for carbon monoxide levels in their expired air usingsimple, portable non invasive carbon monoxidemonitor. Statistical Analysis: Data analysis was done with unpaired student t test. P value of &lt;0.05 was taken to be significant. Results: No significant statistical difference is observed between cases and control groupsin expired aircarbon monoxide levels. Discussion and Conclusion: The lesser half life of carbon monoxide in exhaled air. The longtime interval between the exposure and the time of testing, the metabolic changes associated with pregnancy could have made this test inconclusive. Though gold standard blood analytic method cannot be replaced by this breath monitors,it can be used as a simple portable noninvasive toolto educate pregnant women to avoid exposure to passive smoking.

Decrease in Resting Heart Rate Measured Using Smartphone Apps to Verify Abstinence From Smoking: An Exploratory Study.

IntroductionVerifying self-reports of smoking abstinence is challenging in studies that involve remote data collection. Resting heart rate (HR) decreases during smoking abstinence. This study assessed whether a decrease in resting HR measured using freely available smartphone apps could potentially be used to verify smoking abstinence.MethodsThis study involved a repeated measures experimental design, with data collection in natural setting. Participants were 18 adult, daily smokers. They recorded resting HR in beats per minute (bpm) using freely available smartphone apps during five timepoints (two in the morning and three postnoon) on each of 3 days. The outcome measure was the mean of the postnoon HR recordings. The experimental condition for each of the 3 days (counterbalanced order) was as follows: (1) smoking as usual, (2) not smoking without nicotine replacement therapy (NRT), or (3) not smoking but using NRT. Abstinence was verified using expired-air carbon monoxide (CO) concentration.ResultsCompared with the smoking as usual condition, mean HR was 13.4 bpm lower (95% confidence interval [CI] = 5.4 to 21.4, p = .001) in the not smoking without NRT condition and 10.4 bpm lower (95% CI = 3.1 to 17.8, p = 0.004) in the not smoking with NRT condition. There was no statistically significant difference in HR between the two not smoking conditions (p = .39). Abstinence during not smoking days without and with NRT was CO-verified in 18/18 and in 16/18 cases, respectively.ConclusionsSelf-recording of resting HR in natural setting using smartphone apps shows a reliable decrease in response to smoking abstinence and may provide a basis for remote verification in smoking cessation studies.ImplicationsRemote verification of self-reported abstinence in smoking cessation studies remains challenging. Smoking abstinence has been shown to decrease resting HR under laboratory conditions. This study demonstrated that self-recording using freely available smartphone apps shows reliable decreases in resting HR during smoking abstinence and may provide a basis for inexpensive remote verification of smoking abstinence.

Assessment of the accuracy of salivary cotinine readings from NicAlert strips against a liquid chromatography tandem mass spectrometry assay in self-reported non-smokers who passed carbon monoxide but failed NicAlert validation.

NicAlert produces semi-quantitative assessments of cotinine levels in saliva or urine for verification of smoking abstinence. This study aimed to assess the accuracy of NicAlert readings against a liquid chromatography tandem mass spectrometry assay in smokers who had passed expired-air carbon monoxide (CO) verification but failed NicAlert verification. Comparison of NicAlert readings against readings from a reference assay using liquid chromatography tandem mass spectrometry. Geneva, Switzerland. Self-reported non-smokers (n=92) who in previous testing had CO of 0-3 parts per million (indicating no recent smoking) and reported not using any nicotine product, but had NicAlert readings ≥1 (indicating smoking). NicAlert produces readings of 0, 1 and 2+, which are reported by the manufacturer to correspond to saliva cotinine concentrations of 0-10ng/ml (indicating not smoking), 10-30ng/ml and 30+ ng/ml, respectively. Liquid chromatography tandem mass spectrometry was used as the reference. For 82 participants with a NicAlert reading of 1, only two of the liquid chromatography tandem mass spectrometry values were within the purported range of 10-30ng/ml; 71 were below 4ng/ml and half the values were below 0.5ng/ml. Two of the eight participants with NicAlert readings of 2 had laboratory values within the designated range. Neither of the two participants with NicAlert readings of 3 had a cotinine value within the designated range. In people who had passed carbon monoxide verification, NicAlert readings yielded a very high false-positive rate in detecting levels of cotinine indicative of smoking.

Saliva cotinine concentrations in pregnant women who smoke and use nicotine patches.

Background and AimsDue to concerns about increased exposure to nicotine, pregnant women using nicotine replacement therapy (NRT) to stop smoking are usually advised to stop using NRT if they relapse to smoking. This study investigated whether this is justified. We compared changes in saliva cotinine from baseline to 2 weeks post‐target quit date pregnant smokers who relapsed to smoking and continued to use their patches having been assigned to use nicotine patches or placebo.Design and SettingControlled pre–post design stratified by intervention condition from the ‘Study of Nicotine Patch in Pregnancy’, a randomized, placebo‐controlled trial.ParticipantsA sample of 268 pregnant women, assigned placebo (n = 122) or nicotine (n = 146) patches, who returned for further supplies of patches and who reported any smoking in the week prior to a visit at 2 weeks after their target quit date.MeasurementsSaliva cotinine concentrations were measured at baseline and 2 weeks after participants’ target quit dates. Any smoking in the previous week was assessed by self‐report, validated by expired air carbon monoxide (CO).FindingsThere was no change in saliva cotinine concentrations between baseline and 2 weeks post‐target quit date in saliva cotinine concentration in the nicotine patch group [ratio of geometric means = 0.94, 95% confidence interval (CI) = 0.83 to 1.07; P = 0.37, Bayes factor = 0.15]. However, there was a reduction in reported number of cigarettes smoked/day (mean difference −6, 95% CIs −7 to −5, P < 0.001) and in CO concentrations (mean difference −3.0 parts per million, 95% CIs −4.2 to −1.9, P < 0.001). These changes were not significantly different from changes in the placebo group except for cigarette consumption, which reduced more in the nicotine group (P = 0.046).ConclusionsIn women trying to stop smoking with the aid of a nicotine patch but having smoked at 2 weeks post‐target quit, their nicotine concentration did not change from baseline, but they reported smoking fewer cigarettes and had lower carbon monoxide concentrations.

A feasibility study with embedded pilot randomised controlled trial and process evaluation of electronic cigarettes for smoking cessation in patients with periodontitis

BackgroundTobacco smoking is a major risk factor for several oral diseases, including periodontitis, and electronic cigarettes (e-cigarettes) are increasingly being used for smoking cessation. This study aimed to assess the viability of delivering and evaluating an e-cigarette intervention for smoking cessation within the dental setting, prior to a definitive study.MethodsA feasibility study, comprising a pilot randomised controlled trial and qualitative process evaluation, was conducted over 22 months in the Newcastle upon Tyne Hospitals NHS Dental Clinical Research Facility, UK. The pilot trial comprised a two-armed, parallel group, individually randomised, controlled trial, with 1:1 allocation. Participant eligibility criteria included being a tobacco smoker, having periodontitis and not currently using an e-cigarette. All participants received standard non-surgical periodontal therapies and brief smoking cessation advice. The intervention group additionally received an e-cigarette starter kit with brief training. Proposed outcomes for a future definitive trial, in terms of smoking behaviour and periodontal/oral health, were collected over 6 months to assess data yield and quality and estimates of parameters. Analyses were descriptive, with 95% confidence intervals presented, where appropriate.ResultsEighty participants were successfully recruited from a range of dental settings. Participant retention was 73% (n = 58; 95% CI 62–81%) at 6 months. The e-cigarette intervention was well received, with usage rates of 90% (n = 36; 95% CI 77–96%) at quit date. Twenty percent (n = 8; 95% CI 11–35%) of participants in the control group used an e-cigarette at some point during the study (against advice). The majority of the outcome measures were successfully collected, apart from a weekly smoking questionnaire (only 30% of participants achieved ≥ 80% completion). Reductions in expired air carbon monoxide over 6 months of 6 ppm (95% CI 1–10 ppm) and 12 ppm (95% CI 8–16 ppm) were observed in the control and intervention groups, respectively. Rates of abstinence (carbon monoxide-verified continuous abstinence for 6 months) for the two groups were 5% (n = 2; 95% CI 1–17%; control group) and 15% (n = 6; 95% CI 7–29%; intervention group).ConclusionsData suggest that a definitive trial is feasible and that the intervention may improve smoking quit rates. Insights were gained into how best to conduct the definitive trial and estimates of parameters to inform design were obtained.Trial registrationISRCTN, ISRCTN17731903; registered 19 September 2016 http://www.isrctn.com/ISRCTN17731903.

Randomised, placebo-controlled, double-blind, double-dummy, multicentre trial comparing electronic cigarettes with nicotine to varenicline and to electronic cigarettes without nicotine: the ECSMOKE trial protocol

IntroductionElectronic cigarettes (EC) mainly with nicotine content are widely used worldwide. Although the number of publications about its use is increasing exponentially, evidence-based, unbiased, conclusive, head-to-head comparisons about its efficacy...

Using graphic text-messaging to promote smoking cessation among first-generation Chinese and Korean male immigrants.

First-generation Chinese and Korean male immigrants in the United States are at high risk for tobacco use. This study pilot-tested a graphic, native-language text-messaging intervention to promote smoking cessation among these groups. First-generation Chinese and Korean male immigrant smokers (N = 71) were recruited from the Washington DC area. Participants were randomly assigned to one of four conditions based on a between-subjects 2 (graphic plus text or text-only messages) � 2 (quitline information or quitting tips) design. The text-messaging intervention included 30 text messages in total and lasted one month. Participants completed an expired air carbon monoxide (CO) assessment and self-reported measures at both baseline and follow-up. Results show that, from baseline to follow-up, participants' expired air CO levels decreased significantly (P = 0.001). Attitude toward quitting also became more positive (P = 0.028). Compared with text-only messages, graphic text messages produced greater positive changes in quitting attitudes (P = 0.039) and elicited greater fear response (P = 0.005). Compared with quitting tip messages, quitline information resulted in greater regret (P = 0.016) and fear (P = 0.051). These findings suggest that graphic text-messaging can be an effective method to promote smoking cessation among first-generation Chinese and Korean male immigrants.

Biomarkers of Exposure in ENDS Users, Smokers, and Dual Users of American Indian Descent

We measured biomarkers of exposure among American Indian (AI) ENDS users, smokers, and dual users. Urine was analyzed for total nicotine equivalents (TNE) and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol(NNAL). Expired-air carbon monoxide (CO) was collected. Two analyses were performed. "CO analysis" included smokers and dual users whose CO was ≥ 6 ppm and ENDS users whose CO was < 6 ppm. "NNAL analysis" included smokers and dual users whose NNAL was ≥ 47.3 pg/mg, and ENDS users whose NNAL was < 47.3 pg/mg. Biomarkers were summarized by geometric means (GM) and compared with nonparametric tests. In both analyses, TNE was no different across the groups, and NNAL and CO were lower in ENDS users. In the NNAL analysis the GM of NNAL was 261.4, 6.1, and 228.0 pg/mg among smokers, ENDS users, and dual users (p < .001). Also in the NNAL analysis, the GM of CO was 14.7, 2.4, and 16.8 ppm among smokers, ENDS users, and dual users (p < .001). ENDS users did not differ in nicotine and had lower exposure to a lung carcinogen and a cardiovascular toxicant than smokers or dual users. Dual users and smokers did not differ in biomarker levels. Results should be used to inform tribal regulations and to educate the AI community on ENDS.

717: Prenatal electronic cigarette, dual use and nicotine dependency

Prenatal tobacco use increases risk for nearly all adverse prenatal outcomes. Use of electronic cigarettes (ECIGS) has markedly increased with the perception that they are a safer alternative and may assist with smoking cessation. We previously reported nearly all pregnant women that use ECIGS also simultaneously use conventional cigarettes (dual users). The objective of this study was to identify patterns and predictors of prenatal dual cigarette use. An analysis of an ongoing, prospective multicenter trial using quota sampling was used. Pregnant women in their first trimester, aged 18-44, who currently used conventional cigarettes, ECIGS, or both (dual users) were included. Tobacco use categories were confirmed using preset cotinine limits and maternal self-report. Validated tools were used to measure nicotine dependence (Fagerstrom Test for Nicotine Dependence), expired air carbon monoxide (EACO) levels (Bedford) and depressive symptoms (Edinburgh Postnatal Depressions Scale, EDPS). Data analysis included descriptive statistics, univariate and multivariate analysis predicting the likelihood of nicotine dependence in pregnancy. All statistical analyses were performed using SAS v9.4 with an alpha of 0.05. Total sample included 117 women (dual, n=27; convention-only, n=90). EACO levels and number of cigarettes per day were similar between conventional and dual users. Prenatal dual use and increased depressive symptoms were significantly predictive of higher dependence (p=007). Controlling for age, race and education, dual users had an average of 1-point higher on the Fagerstrom index (beta=0.93; p=.034) with a range of 0-10, compared to conventional cigarette-only users. Every 5-point increase (range, 0-30) in depressive symptoms was associated with a 0.5 point increase in nicotine dependence (p=.019). Age, race and education were not associated with dependence in this sample. Pregnant dual users smoke similar amounts of cigarettes per day and have comparable EACO levels to conventional users, though exhibit higher levels of nicotine dependency, indicating ECIGS may not be effective smoking cessation aids during pregnancy. Further research is warranted to determine the effect of ECIGS on birth outcomes.