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Background In Scotland, and in several other countries, most second-hand smoke exposure now occurs in low-income households, where housing constraints and sole parenting often make it harder to create a smoke-free home. This pilot study provided people who smoke with a free 12-week supply of nicotine replacement therapy through local community pharmacies to reduce smoking indoors. Methods Twenty-five parents/caregivers who smoked in the home and cared for children at least weekly were recruited via Facebook during the COVID-19 pandemic. Air quality (PM 2.5 ) was monitored in participant homes for seven days before their first pharmacy visit and 12 weeks later. Qualitative interviews ( N  = 14) were conducted with 13 participants who completed the study and one who withdrew part-way through. The interviews explored views/experiences of using nicotine replacement therapy to help create a smoke-free home. Another participant took part in a shorter telephone discussion at their request, with detailed notes taken by the interviewer, because of their speech disorder. Results Three participants reported smoking outdoors only, one of whom subsequently quit smoking. Six participants reported reduced cigarette consumption by 50% in the home, four reported no (sustained) reduction and one reported increased smoking indoors. Self-reported outcomes were not always consistent with PM 2.5 readings. Participants’ experiences of accessing nicotine replacement therapy through community pharmacies varied. Some suggested ongoing support to use nicotine replacement products could better assist behavioural change, and that access could be streamlined by posting products to the home. Several suggested that focusing on changing home smoking behaviours using nicotine replacement therapy might facilitate a future quit attempt. Conclusion Access to free nicotine replacement therapy for temporary use indoors may support some people who smoke to reduce children’s exposure to second-hand smoke. Our findings confirm the need to modify the intervention before undertaking a definitive trial to assess the effectiveness of this approach. This work is now underway.

Background Cigarette smoking has major detrimental effects on oral health. Tobacco interventions in dental settings are effective, but rarely delivered. The American Dental Hygienists Association recommends that oral health providers: Ask patients about tobacco use, Advise quitting tobacco use, and Refer to state quitlines (Ask-Advise-Refer; AAR). While AAR connects patients to counseling, it does not directly connect patients to medication. Nicotine replacement therapy sampling (NRTS) is an empirically supported intervention to provide starter packs of nicotine replacement therapy (NRT) to people who smoke. NRTS combined with AAR could be an effective tobacco treatment intervention for dental settings. Methods This manuscript describes the study protocol for the Free Samples for Health (FreSH) study, a group randomized clinical trial testing the effectiveness of NRTS + AAR vs. AAR alone on long-term smoking abstinence. Fifty dental practices in the Midwest and Northeast nodes of the National Dental Practice-Based Research Network are randomly assigned to provide AAR and either a 2-week supply of 14-mg nicotine patches and 4-mg nicotine lozenges (NRTS condition) or an electric toothbrush (ET condition). Approximately 1,200 patients who currently smoke—regardless of interest in quitting— are recruited during dental visits. Participants complete a baseline survey in-person, then after visit, 1-, 3-, and 6-month follow-up surveys remotely. The primary outcome is carbon monoxide-confirmed 7-day point prevalence abstinence from combustible tobacco measured at 6 months post-enrollment. Secondary outcomes include: 24-h intentional quit attempts, change in cigarettes smoked per day, NRT utilization, attitudes toward NRT, intention to use NRT, and intention to quit smoking. A key informant process evaluation and cost effectiveness analysis will provide information for future implementation of NRTS. Discussion This is the first clinical trial to assess the effectiveness of NRTS on promoting smoking cessation in dental settings. If effective, this treatment could be implemented to increase the provision of smoking cessation interventions in dental settings to provide an additional treatment access point for people who smoke. Trial Registration. Registered at ClincalTrials.gov (NCT05627596) on 11/25/2022.

Varenicline and oral nicotine replacement therapy (NRT) have each been shown to increase the likelihood of smoking cessation, but their combination has not been studied. In addition, smoking cessation medication adherence is often poor, thus, challenging the ability to evaluate medication efficacy. This study examined the effects of combined varenicline and oral NRT and smartphone medication reminders on pharmacotherapy adherence and smoking abstinence among adults enrolled in smoking cessation treatment. A 2×2 factorial design was used. Participants (N=34) were randomized to (1) varenicline + oral NRT (VAR+NRT) or varenicline alone (VAR) and (2) smartphone medication reminder messages (REM) or no reminder messages (NREM) over 13 weeks. Participants assigned to VAR+REM received varenicline reminder prompts, and those assigned to VAR+NRT+REM also received reminders to use oral NRT. The other 2 groups (VAR+NREM and VAR+NRT+NREM) did not receive medication reminders. Participants were not blinded to intervention groups. All participants received tobacco cessation counseling. Smartphone assessments of smoking as well as varenicline and NRT use (if applicable) were prompted daily through the first 12 weeks after a scheduled quit date. Descriptive statistics were generated to characterize the relations between medication and reminder group assignments with daily smoking, daily varenicline adherence, and daily quantity of oral NRT used. Participants completed follow-up assessments for 26 weeks after the quit date. Participants were predominantly White (71%), and half were female (50%). On average, participants were 54.2 (SD 9.4) years of age, they smoked an average of 19.0 (SD 9.0) cigarettes per day and had smoked for 34.6 (SD 12.7) years. Descriptively, participants assigned to VAR+NRT reported more days of smoking abstinence compared to VAR (29.3 vs 26.3 days). Participants assigned to REM reported more days of smoking abstinence than those assigned to NREM (40.5 vs 21.8 days). Participants assigned to REM were adherent to varenicline on more days compared to those assigned to NREM (58.6 vs 40.5 days), and participants assigned to VAR were adherent to varenicline on more days than those assigned to VAR + NRT (50.7 vs 43.3 days). In the subsample of participants assigned to VAR+NRT, participants assigned to REM reported more days where ≥5 pieces of NRT were used than NREM (14.0 vs 7.4 days). Average overall medication adherence (assessed via the Medication Adherence Questionnaire) showed the same pattern as the daily smartphone-based adherence assessments. Preliminary findings indicated that smoking cessation interventions may benefit from incorporating medication reminders and combining varenicline with oral NRT, though combining medications may be associated with poorer adherence. Further study is warranted. ClinicalTrials.gov NCT03722966; https://classic.clinicaltrials.gov/ct2/show/NCT03722966.

Background: Higher cigarette prices result in decreased cigarette consumption, but some smokers may seek lower-taxed cigarette sources. This price avoidance behaviour likely dampens the health impact of higher cigarette prices although it has not been thoroughly studied. Objective: To describe the characteristics of smokers who purchase low/untaxed cigarettes and to examine how this behaviour is associated with subsequent changes in smoking behaviours. Methods: Telephone survey data from 8930 smokers from the International Tobacco Control (ITC) Four Country Survey (ITC-4) were used to assess cigarette purchase patterns and smoking behaviours in Wave 1 conducted from October to December 2002 and subsequently followed seven months later in Wave 2. Respondents’ smoking status, attempts to quit, amount smoked, and cigarette purchase patterns were assessed in both waves. Results: Rates of purchase from a low/untaxed source at the respondents’ last cigarette purchase differed notably between countries at Wave 1, from less than 1% in Australia to 15% in the United Kingdom. In the UK, but not the other countries, this increased significantly to 20% at Wave 2. Smokers who were older, white/English speakers, had higher incomes, and had higher levels of education were more likely to report purchasing cigarettes from a low/untaxed source on their last purchase. Those who reported purchasing from a low/untaxed source on their last purchase at Wave 1 were less likely to have tried to quit smoking quit smoking by Wave 2 (relative risk 0.70, p < 0.01), while no overall significant association with smoking cessation was observed. Conclusion: Data from this study indicate that there are lower levels of making a quit attempt among purchasers of low/untaxed cigarettes compared to purchasers of full-priced cigarettes. The availability of low/untaxed cigarettes may mitigate the influence of increases in cigarette prices.

IntroductionAn admission with STEMI is a powerful motivating event for SC with successful patients adding an average of five healthy years of life compared to ongoing smokers. Continuing smokers are also 4 times more likely to suffer from recurrent myocardial infarction. NRT has been shown to improve SC in out-patient settings, however in a STEMI cohort, might reintroduce nicotine after a period of inpatient abstinence, thereby confounding efforts to give up. The safety of NRT in STEMI patients has been demonstrated, however the efficacy of NRT compared to advice and support and nicotine abstinence has not been fully tested. The aim of this study is to investigate the impact of NRT on smoking cessation success in patients admitted with STEMI.MethodsWe assessed STEMI patients admitted to a large regional heart attack centre who were smokers at the time of admission. We grouped patients by prescription of NRT as an in-patient (NRT group) and those without prescription (No NRT). All patients were then followed up to determine smoking status at varying timepoints in clinic, cardiac rehabilitation or by telephone (Mean time to follow up 9 months, STDEV 8 Months)ResultsFrom December 2020 to December 2022, 124 (31 Females, 25%, 18 diabetic, 14.5%) active smokers suffering STEMI were admitted. 55 patients (44%) received NRT, 69 (56%). did not (no NRT). The Mean age of participants was 59 (range 31–84 years). Mean (STDEV) follow time for the NRT group was 10 months (8), and for the No-NRT group was 8 months (8).In the NRT group 30/55 (54.5%) were actively smoking at follow up, whereas in the No NRT group 22/69 (31.9%) were smoking at follow up (P=0.017).ConclusionA STEMI is an important life changing occurrence in a patient’s life which can provide a powerful motivation to quit smoking. Patients typically have a valuable nicotine free period during their index admission. It is possible that the introduction of nicotine as a therapy during this admission is counterproductive. In our cohort, NRT prescription was associated with a significantly higher risk of smoking at follow up. These results are subject to a number of confounding variables, but are hypothesis generating and suggest that further, large scale studies in this very high-risk group are warranted.Conflict of InterestNone

Background: Poor adherence to nicotine replacement therapy (NRT) is associated with low rates of smoking cessation. Hence, this study aims to identify and map patient-related factors associated with adherence to NRT using the capability, opportunity, motivation, and behaviour (COM-B) model. Methods: A systematic review was conducted by searching five databases (MEDLINE, Scopus, EMBASE, CINAHL, and PsycINFO) and grey literature on 30 August 2020. Data were extracted, thematically analysed, and mapped to the COM-B model. The Joanna Briggs Institute (JBI) critical appraisal tool was utilised to assess the quality of studies. Results: A total of 2929 citations were screened, and 26 articles with a total of 13,429 participants included. Thirty-one factors were identified and mapped to COM-B model: psychological capability (forgetfulness, education), physical capability (level of nicotine dependence, withdrawal symptoms), reflective motivation (perception about NRT and quitting), automatic motivation (alcohol use, stress, depression), physical opportunity (cost), and social opportunity (social support). The most prominent element associated with adherence was reflective motivation followed by physical capability and automatic motivation. Conclusions: Multiple personal, social, and environmental factors affect NRT adherence. Hence, it is recommended to implement a multifaceted behavioural intervention incorporating factors categorised under the COM-B model, which is the hub of the behaviour change wheel (BCW) to improve adherence and quitting.

Background Smoking is a major risk factor for cardiovascular disease and smoking cessation reduces excess risk. E-cigarettes are popular for smoking cessation but there is little evidence on their cardiovascular health effect. Our objective was to compare the medium- and longer-term cardiovascular effects in smokers attempting to quit smoking using e-cigarettes with or without nicotine or prescription nicotine replacement therapy (NRT). Methods This was a single-center, pragmatic three-arm randomized (1:1:1) controlled trial, which recruited adult smokers (≥ 10 cigarettes/day), who were willing to attempt to stop smoking with support ( n  = 248). Participants were randomized to receive behavioral support with either (a) e-cigarettes with 18 mg/ml nicotine, (b) e-cigarettes without nicotine, and (c) NRT. Flow-mediated dilation (%FMD) and peak cutaneous vascular conductance (CVCmax) responses to acetylcholine (ACh) and sodium nitroprusside (SNP), mean arterial pressure (MAP), and other outcomes were recorded at baseline, 3, and 6 months after stopping smoking. Data were analyzed using generalized estimating equations (GEE). Results At 3- and 6-month follow-up, %FMD showed an improvement over baseline in all three groups (e.g., p  < 0.0001 at 6 months). Similarly, ACh, SNP, and MAP improved significantly over baseline in all groups both at 3 and 6 months (e.g., ACh: p  = 0.004, at 6 months). Conclusions Smokers attempting to quit experienced positive cardiovascular impact after both a 3- and 6-month period. None of the groups (i.e., nicotine-containing and nicotine-free e-cigarettes or NRT) offered superior cardiovascular benefits to the others. Trial registration ClinicalTrials.gov NCT03061253 . Registered on 17 February 2017.

With the highest cancer incidence and mortality rates in the country, rural Appalachia has experienced a decades-long health decline, due in part to high smoking rates. Cigarette smoking prevalence exceeds 30% in much of the region. Oral nicotine pouches (ONPs), which contain nicotine but no tobacco, present an unexplored opportunity to reduce cigarette smoking and cancer incidence. We outline the protocol for the Appalachian Research to Impact Smoking's Effects (ARISE) study, a randomized controlled trial to determine whether ONPs affect cigarette smoking patterns short- and long-term, and to evaluate their abuse liability versus nicotine replacement therapy (NRT) in a large sample of Appalachian smokers (clinicaltrials.gov: NCT06763536). Between 2025 and 2029, we will recruit 1,000 adult smokers living in rural Appalachian counties across 11 states. Participants will be identified via media outreach, mobile cancer screening, community events, and respondent-driven sampling, then randomized to ONP or NRT and complete four study phases: Baseline, Sampling, Switch, and Observation. In the Sampling phase, participants will receive varied flavors and nicotine strengths of their assigned product and select preferred options for use. During the Switch Phase, they will attempt to quit smoking and switch completely to their assigned product. The Observation phase will monitor tobacco use after discontinuation of study products. Study procedures will be conducted online and by mail, including surveys, expired carbon monoxide verification, and product delivery. The primary outcome is 7-day biochemically verified cigarette abstinence at the end of the Switch Phase. Secondary outcomes include switching rates, product appeal, craving, withdrawal, dependence, and purchases during the Observation phase. An intention-to-treat log-binomial regression model will estimate the effect of intervention assignment on cigarette abstinence. Results will inform whether and how ONPs should be regulated, approached clinically, and used in public health interventions to reduce the burdens of cigarette smoking in Appalachia.

Background People with severe mental ill health are more likely to smoke than those in the general population. It is therefore important that effective smoking cessation strategies are used to help people with severe mental ill health to stop smoking. This study aims to assess the effectiveness and cost –effectiveness of smoking cessation and reduction strategies in adults with severe mental ill health in both inpatient and outpatient settings. Methods This is an update of a previous systematic review. Electronic databases were searched during September 2016 for randomised controlled trials comparing smoking cessation interventions to each other, usual care, or placebo. Data was extracted on biochemically-verified, self-reported smoking cessation (primary outcome), as well as on smoking reduction, body weight, psychiatric symptom, and adverse events (secondary outcomes). Results We included 26 trials of pharmacological and/or behavioural interventions. Eight trials comparing bupropion to placebo were pooled showing that bupropion improved quit rates significantly in the medium and long term but not the short term (short term RR = 6.42 95% CI 0.82–50.07; medium term RR = 2.93 95% CI 1.61–5.34; long term RR = 3.04 95% CI 1.10–8.42). Five trials comparing varenicline to placebo showed that that the addition of varenicline improved quit rates significantly in the medium term (RR = 4.13 95% CI 1.36–12.53). The results from five trials of specialised smoking cessation programmes were pooled and showed no evidence of benefit in the medium (RR = 1.32 95% CI 0.85–2.06) or long term (RR = 1.33 95% CI 0.85–2.08). There was insufficient data to allowing pooling for all time points for varenicline and trials of specialist smoking cessation programmes. Trials suggest few adverse events although safety data were not always reported. Only one pilot study reported cost effectiveness data. Conclusions Bupropion and varenicline, which have been shown to be effective in the general population, also work for people with severe mental ill health and their use in patients with stable psychiatric conditions. Despite good evidence for the effectiveness of smoking cessation interventions for people with severe mental ill health, the percentage of people with severe mental ill health who smoke remains higher than that for the general population.

The nicotine metabolite ratio (NMR) has been informative in selecting treatment choices for nicotine dependence and increasing treatment efficacy in Western settings; however, the clinical utility of the NMR among smokers in low-resource settings remains unclear. Prospective analysis was conducted using data from a randomized controlled trial of smoking cessation among adults living with HIV, to examine the association between the NMR and response to smoking cessation treatment. NMR was assessed using bio-banked urine samples collected at baseline. Self-reported smoking at 6 months was verified using a urine cotinine test and exhaled breath carbon monoxide (CO). We found no associations between the NMR and smoking abstinence (adjusted risk ratio (aRR) = 0.82; 95% CI: 0.45, 1.49; p = 0.53). No evidence of effect modification by treatment conditions was observed on the multiplicative scale (aRR = 1.17; 95% CI: 0.32, 4.30; p = 0.81) or additive scale (adjusted relative excess risk due to interaction (aRERI) = 0.10; 95% CI: −1.16, 1.36; p = 0.44). Our results suggest that the NMR may not be a viable approach for selecting smoking cessation treatment in this setting, given the minimal variability in our sample and racial/ethnic makeup of this population.