Characterising smoking and nicotine use behaviours among women of reproductive age: a 10-year population study in England.

BACKGROUND: Tobacco smoking affects women's fertility and is associated with substantial risks of adverse pregnancy outcomes. This study explored trends by socioeconomic position in patterns of smoking, use of non-combustible nicotine products, and quitting activity among women of reproductive age in England. METHODS: Data come from a nationally representative monthly cross-sectional survey. Between October 2013 and October 2023, 197,266 adults (≥ 18 years) were surveyed, of whom 44,052 were women of reproductive age (18-45 years). Main outcome measures were current smoking, vaping, and use of nicotine replacement therapy (NRT), heated tobacco products (HTPs), and nicotine pouches; mainly/exclusively smoking hand-rolled cigarettes and level of dependence among current smokers; past-year quit attempts among past-year smokers; and success of quit attempts among those who tried to quit. We modelled time trends in these outcomes, overall and by occupational social grade (ABC1 = more advantaged/C2DE = less advantaged). RESULTS: Smoking prevalence among women of reproductive age fell from 28.7% [95%CI = 26.3-31.2%] to 22.4% [19.6-25.5%] in social grades C2DE but there was an uncertain increase from 11.7% [10.2-13.5%] to 14.9% [13.4-16.6%] in ABC1. By contrast, among all adults and among men of the same age, smoking prevalence remained relatively stable in ABC1. Vaping prevalence among women of reproductive age more than tripled, from 5.1% [4.3-6.0%] to 19.7% [18.0-21.5%], with the absolute increase more pronounced among those in social grades C2DE (reaching 26.7%; 23.3-30.3%); these changes were larger than those observed among all adults but similar to those among men of the same age. The proportion of smokers mainly/exclusively smoking hand-rolled cigarettes increased from 40.5% [36.3-44.9%] to 61.4% [56.5-66.1%] among women of reproductive age; smaller increases were observed among all adults and among men of the same age. Patterns on other outcomes were largely similar between groups. CONCLUSIONS: Among women of reproductive age, there appears to have been a rise in smoking prevalence in the more advantaged social grades over the past decade. Across social grades, there have been substantial increases in the proportion of women of reproductive age who vape and shifts from use of manufactured to hand-rolled cigarettes among those who smoke. These changes have been more pronounced than those observed in the general adult population over the same period.

A smoking cessation smartphone app that delivers real-time 'context aware' behavioural support: the Quit Sense feasibility RCT.

Background: During a quit attempt, cues from a smoker's environment are a major cause of brief smoking lapses, which increase the risk of relapse. Quit Sense is a theory-guided Just-In-Time Adaptive Intervention smartphone app, providing smokers with the means to learn about their environmental smoking cues and provides 'in the moment' support to help them manage these during a quit attempt. Objective: To undertake a feasibility randomised controlled trial to estimate key parameters to inform a definitive randomised controlled trial of Quit Sense. Design: A parallel, two-arm randomised controlled trial with a qualitative process evaluation and a 'Study Within A Trial' evaluating incentives on attrition. The research team were blind to allocation except for the study statistician, database developers and lead researcher. Participants were not blind to allocation. Setting: Online with recruitment, enrolment, randomisation and data collection (excluding manual telephone follow-up) automated through the study website. Participants: Smokers (323 screened, 297 eligible, 209 enrolled) recruited via online adverts on Google search, Facebook and Instagram. Interventions: Participants were allocated to 'usual care' arm (n = 105; text message referral to the National Health Service SmokeFree website) or 'usual care' plus Quit Sense (n = 104), via a text message invitation to install the Quit Sense app. Main outcome measures: Follow-up at 6 weeks and 6 months post enrolment was undertaken by automated text messages with an online questionnaire link and, for non-responders, by telephone. Definitive trial progression criteria were met if a priori thresholds were included in or lower than the 95% confidence interval of the estimate. Measures included health economic and outcome data completion rates (progression criterion #1 threshold: ≥ 70%), including biochemical validation rates (progression criterion #2 threshold: ≥ 70%), recruitment costs, app installation (progression criterion #3 threshold: ≥ 70%) and engagement rates (progression criterion #4 threshold: ≥ 60%), biochemically verified 6-month abstinence and hypothesised mechanisms of action and participant views of the app (qualitative). Results: Self-reported smoking outcome completion rates were 77% (95% confidence interval 71% to 82%) and health economic data (resource use and quality of life) 70% (95% CI 64% to 77%) at 6 months. Return rate of viable saliva samples for abstinence verification was 39% (95% CI 24% to 54%). The per-participant recruitment cost was £19.20, which included advert (£5.82) and running costs (£13.38). In the Quit Sense arm, 75% (95% CI 67% to 83%; 78/104) installed the app and, of these, 100% set a quit date within the app and 51% engaged with it for more than 1 week. The rate of 6-month biochemically verified sustained abstinence, which we anticipated would be used as a primary outcome in a future study, was 11.5% (12/104) in the Quit Sense arm and 2.9% (3/105) in the usual care arm (estimated effect size: adjusted odds ratio = 4.57, 95% CIs 1.23 to 16.94). There was no evidence of between-arm differences in hypothesised mechanisms of action. Three out of four progression criteria were met. The Study Within A Trial analysis found a £20 versus £10 incentive did not significantly increase follow-up rates though reduced the need for manual follow-up and increased response speed. The process evaluation identified several potential pathways to abstinence for Quit Sense, factors which led to disengagement with the app, and app improvement suggestions. Limitations: Biochemical validation rates were lower than anticipated and imbalanced between arms. COVID-19-related restrictions likely limited opportunities for Quit Sense to provide location tailored support. Conclusions: The trial design and procedures demonstrated feasibility and evidence was generated supporting the efficacy potential of Quit Sense. Future work: Progression to a definitive trial is warranted providing improved biochemical validation rates. Trial registration: This trial is registered as ISRCTN12326962. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: 17/92/31) and is published in full in Public Health Research; Vol. 12, No. 4. See the NIHR Funding and Awards website for further award information.

Smokers often fail to quit because of urges to smoke triggered by their surroundings (e.g. being around smokers). We developed a smartphone app ('Quit Sense') which learns about an individual's surroundings and locations where they smoke. During a quit attempt, Quit Sense uses in-built sensors to identify when smokers are in those locations and sends 'in the moment' advice to help prevent them from smoking. We ran a feasibility study to help plan for a future large study to see if Quit Sense helps smokers to quit. This feasibility study was designed to tell us how many participants complete study measures; recruitment costs; how many participants install and use Quit Sense; and estimate whether Quit Sense may help smokers to stop and how it might do this. We recruited 209 smokers using online adverts on Google search, Facebook and Instagram, costing £19 per participant. Participants then had an equal chance of receiving a web link to the National Health Service SmokeFree website ('usual care group') or receive that same web link plus a link to the Quit Sense app ('Quit Sense group'). Three-quarters of the Quit Sense group installed the app on their phone and half of these used the app for more than 1 week. We followed up 77% of participants at 6 months to collect study data, though only 39% of quitters returned a saliva sample for abstinence verification. At 6 months, more people in the Quit Sense group had stopped smoking (12%) than the usual care group (3%). It was not clear how the app helped smokers to quit based on study measures, though interviews found that the process of training the app helped people quit through learning about what triggered their smoking behaviour. The findings support undertaking a large study to tell us whether Quit Sense really does help smokers to quit.

Cessation of Smoking Trial in the Emergency Department (COSTED): a multicentre randomised controlled trial.

BACKGROUND: Supporting people to quit smoking is one of the most powerful interventions to improve health. The Emergency Department (ED) represents a potentially valuable opportunity to deliver a smoking cessation intervention if it is sufficiently resourced. The objective of this trial was to determine whether an opportunistic ED-based smoking cessation intervention can help people to quit smoking. METHODS: In this multicentre, parallel-group, randomised controlled superiority trial conducted between January and August 2022, adults who smoked daily and attended one of six UK EDs were randomised to intervention (brief advice, e-cigarette starter kit and referral to stop smoking services) or control (written information on stop smoking services). The primary outcome was biochemically validated abstinence at 6 months. RESULTS: An intention-to-treat analysis included 972 of 1443 people screened for inclusion (484 in the intervention group, 488 in the control group). Of 975 participants randomised, 3 were subsequently excluded, 17 withdrew and 287 were lost to follow-up. The 6-month biochemically-verified abstinence rate was 7.2% in the intervention group and 4.1% in the control group (relative risk 1.76; 95% CI 1.03 to 3.01; p=0.038). Self-reported 7-day abstinence at 6 months was 23.3% in the intervention group and 12.9% in the control group (relative risk 1.80; 95% CI 1.36 to 2.38; p<0.001). No serious adverse events related to taking part in the trial were reported. CONCLUSIONS: An opportunistic smoking cessation intervention comprising brief advice, an e-cigarette starter kit and referral to stop smoking services is effective for sustained smoking abstinence with few reported adverse events. TRIAL REGISTRATION NUMBER: NCT04854616.

Selecting an e-cigarette for use in smoking cessation interventions and healthcare services: findings from patient and public consultation for the COSTED trial.

OBJECTIVES: The Cessation of Smoking Trial in the Emergency Department (COSTED) trial aims to ascertain whether brief advice, the provision of an e-cigarette starter kit and referral to stop smoking services (SSS), increases smoking cessation in people attending the emergency department. Patient and public involvement (PPI) and scoping work were undertaken to select an appropriate e-cigarette for the trial. DESIGN AND SETTING: PPI consultation and feasibility scoping about potential devices with a professional and lay panel, all based in England. Consultation was via email, telephone or video interview. This work took place between April and July 2021, prior to recruitment commencing for the COSTED trial. PARTICIPANTS: A professional panel (n=7) including representatives from academia, SSS and the independent vaping industry, and a PPI lay panel (n=3) who smoke or vape. RESULTS: The professional panel recommended a shortlist of devices which were tested by the PPI lay panel. Key criteria for selecting an appropriate e-cigarette for smoking cessation intervention include satisfaction, usability, affordability and availability. Simplicity of use was highlighted by the PPI lay panel, who found refillable devices complex, and availability of consumables was highlighted as more important than price by both panels. The pod device selected for inclusion was rated highly for satisfaction and usability and had mid-price range and consumables which were widely available. CONCLUSIONS: To select the most appropriate device for the COSTED trial, each criterion required assessment to ensure the best fit to the intervention context and needs of the target population. There is a need for guidance to help enable decision-making about choice of vape products, tailored to service users' needs. We propose a bespoke checklist template, based on our findings, to assist with this process. This has applicability to the recent government announcement of a 'Swap to Stop' programme, offering a vaping starter kit to smokers across England, allowing services flexibility to shape their own programmes and models of delivery. TRIAL REGISTRATION NUMBER: Clinical trial number NCT04854616; pre-results.

Electronic cigarettes for smoking cessation.

BACKGROUND: Electronic cigarettes (ECs) are handheld electronic vaping devices which produce an aerosol by heating an e-liquid. People who smoke, healthcare providers and regulators want to know if ECs can help people quit smoking, and if they are safe to use for this purpose. This is a review update conducted as part of a living systematic review. OBJECTIVES: To examine the safety, tolerability and effectiveness of using electronic cigarettes (ECs) to help people who smoke tobacco achieve long-term smoking abstinence, in comparison to non-nicotine EC, other smoking cessation treatments and no treatment. SEARCH METHODS: We searched the Cochrane Tobacco Addiction Group's Specialized Register to 1 February 2023, and Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and PsycINFO to 1 July 2023, and reference-checked and contacted study authors. SELECTION CRITERIA: We included trials in which people who smoke were randomized to an EC or control condition. We also included uncontrolled intervention studies in which all participants received an EC intervention as these studies have the potential to provide further information on harms and longer-term use. Studies had to report an eligible outcome. DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methods for screening and data extraction. Critical outcomes were abstinence from smoking after at least six months, adverse events (AEs), and serious adverse events (SAEs). We used a fixed-effect Mantel-Haenszel model to calculate risk ratios (RRs) with a 95% confidence interval (CI) for dichotomous outcomes. For continuous outcomes, we calculated mean differences. Where appropriate, we pooled data in pairwise and network meta-analyses (NMA). MAIN RESULTS: We included 88 completed studies (10 new to this update), representing 27,235 participants, of which 47 were randomized controlled trials (RCTs). Of the included studies, we rated ten (all but one contributing to our main comparisons) at low risk of bias overall, 58 at high risk overall (including all non-randomized studies), and the remainder at unclear risk. There is high certainty that nicotine EC increases quit rates compared to nicotine replacement therapy (NRT) (RR 1.59, 95% CI 1.29 to 1.93; I2 = 0%; 7 studies, 2544 participants). In absolute terms, this might translate to an additional four quitters per 100 (95% CI 2 to 6 more). There is moderate-certainty evidence (limited by imprecision) that the rate of occurrence of AEs is similar between groups (RR 1.03, 95% CI 0.91 to 1.17; I2 = 0%; 5 studies, 2052 participants). SAEs were rare, and there is insufficient evidence to determine whether rates differ between groups due to very serious imprecision (RR 1.20, 95% CI 0.90 to 1.60; I2 = 32%; 6 studies, 2761 participants; low-certainty evidence). There is moderate-certainty evidence, limited by imprecision, that nicotine EC increases quit rates compared to non-nicotine EC (RR 1.46, 95% CI 1.09 to 1.96; I2 = 4%; 6 studies, 1613 participants). In absolute terms, this might lead to an additional three quitters per 100 (95% CI 1 to 7 more). There is moderate-certainty evidence of no difference in the rate of AEs between these groups (RR 1.01, 95% CI 0.91 to 1.11; I2 = 0%; 5 studies, 1840 participants). There is insufficient evidence to determine whether rates of SAEs differ between groups, due to very serious imprecision (RR 1.00, 95% CI 0.56 to 1.79; I2 = 0%; 9 studies, 1412 participants; low-certainty evidence). Due to issues with risk of bias, there is low-certainty evidence that, compared to behavioural support only/no support, quit rates may be higher for participants randomized to nicotine EC (RR 1.88, 95% CI 1.56 to 2.25; I2 = 0%; 9 studies, 5024 participants). In absolute terms, this represents an additional four quitters per 100 (95% CI 2 to 5 more). There was some evidence that (non-serious) AEs may be more common in people randomized to nicotine EC (RR 1.22, 95% CI 1.12 to 1.32; I2 = 41%, low-certainty evidence; 4 studies, 765 participants) and, again, insufficient evidence to determine whether rates of SAEs differed between groups (RR 0.89, 95% CI 0.59 to 1.34; I2 = 23%; 10 studies, 3263 participants; very low-certainty evidence). Results from the NMA were consistent with those from pairwise meta-analyses for all critical outcomes, and there was no indication of inconsistency within the networks. Data from non-randomized studies were consistent with RCT data. The most commonly reported AEs were throat/mouth irritation, headache, cough, and nausea, which tended to dissipate with continued EC use. Very few studies reported data on other outcomes or comparisons, hence, evidence for these is limited, with CIs often encompassing both clinically significant harm and benefit. AUTHORS' CONCLUSIONS: There is high-certainty evidence that ECs with nicotine increase quit rates compared to NRT and moderate-certainty evidence that they increase quit rates compared to ECs without nicotine. Evidence comparing nicotine EC with usual care/no treatment also suggests benefit, but is less certain due to risk of bias inherent in the study design. Confidence intervals were for the most part wide for data on AEs, SAEs and other safety markers, with no difference in AEs between nicotine and non-nicotine ECs nor between nicotine ECs and NRT. Overall incidence of SAEs was low across all study arms. We did not detect evidence of serious harm from nicotine EC, but the longest follow-up was two years and the number of studies was small. The main limitation of the evidence base remains imprecision due to the small number of RCTs, often with low event rates. Further RCTs are underway. To ensure the review continues to provide up-to-date information to decision-makers, this review is a living systematic review. We run searches monthly, with the review updated when relevant new evidence becomes available. Please refer to the Cochrane Database of Systematic Reviews for the review's current status.

Mobile Phone Text Messages to Support People to Stop Smoking by Switching to Vaping: Codevelopment, Coproduction, and Initial Testing Study.

BACKGROUND: SMS text messages are affordable, scalable, and effective smoking cessation interventions. However, there is little research on SMS text message interventions specifically designed to support people who smoke to quit by switching to vaping. OBJECTIVE: Over 3 phases, with vapers and smokers, we codeveloped and coproduced a mobile phone SMS text message program. The coproduction paradigm allowed us to collaborate with researchers and the community to develop a more relevant, acceptable, and equitable SMS text message program. METHODS: In phase 1, we engaged people who vape via Twitter and received 167 responses to our request to write SMS text messages for people who wish to quit smoking by switching to vaping. We screened, adjusted, refined, and themed the messages, resulting in a set of 95 that were mapped against the Capability, Opportunity, and Motivation-Behavior constructs. In phase 2, we evaluated the 95 messages from phase 1 via a web survey where participants (66/202, 32.7% woman) rated up to 20 messages on 7-point Likert scales on 9 constructs: being understandable, clear, believable, helpful, interesting, inoffensive, positive, and enthusiastic and how happy they would be to receive the messages. In phase 3, we implemented the final set of SMS text messages as part of a larger randomized optimization trial, in which 603 participants (mean age 38.33, SD 12.88 years; n=369, 61.2% woman) received SMS text message support and then rated their usefulness and frequency and provided free-text comments at the 12-week follow-up. RESULTS: For phase 2, means and SDs were calculated for each message across the 9 constructs. Those with means below the neutral anchor of 4 or with unfavorable comments were discussed with vapers and further refined or removed. This resulted in a final set of 78 that were mapped against early, mid-, or late stages of quitting to create an order for the messages. For phase 3, a total of 38.5% (232/603) of the participants provided ratings at the 12-week follow-up. In total, 69.8% (162/232) reported that the SMS text messages had been useful, and a significant association between quit rates and usefulness ratings was found (χ21=9.6; P=.002). A content analysis of free-text comments revealed that the 2 most common positive themes were helpful (13/47, 28%) and encouraging (6/47, 13%) and the 2 most common negative themes were too frequent (9/47, 19%) and annoying (4/47, 9%). CONCLUSIONS: In this paper, we describe the initial coproduction and codevelopment of a set of SMS text messages to help smokers stop smoking by transitioning to vaping. We encourage researchers to use, further develop, and evaluate the set of SMS text messages and adapt it to target populations and relevant contexts.

Do respiratory physicians not care about people who smoke?

Nicotine containing vapes (e-cigarettes) are an effective tool to support people who smoke to quit tobacco. Despite this clinicians are wary of promoting vaping to their patients due to concerns that there may not be 'enough' evidence and about youth uptake of vaping. In this opinion article we discuss clinicians' views of vaping and consider the implications that harm misperceptions may have for public health.

BabyBreathe trial: protocol for a randomised controlled trial of a complex intervention to prevent postpartum return to smoking.

INTRODUCTION: Many people quit smoking during pregnancy, but postpartum smoking relapse is common. Maintaining smoking abstinence achieved during pregnancy is key to improving maternal and child health. There are no evidence-based interventions for preventing postpartum smoking relapse. This trial aims to determine whether an intervention to prevent postpartum relapse is effective and cost-effective. METHODS AND ANALYSIS: A randomised controlled trial of a complex intervention to prevent postpartum smoking relapse (BabyBreathe), with internal pilot, economic and process evaluations. Participants are adults who are pregnant and who report having quit smoking in the 12 months before, or during pregnancy. Participants are eligible if they read and understand English, and provide informed consent. Following consent and biochemical validation of smoking abstinence, participants are randomised to intervention or usual care/control (no specific relapse prevention support). The BabyBreathe intervention consists of manualised advice from a trained member of the health visiting service, health information leaflets for participants and partners, access to the BabyBreathe website and app. At the time of birth, participants are posted the BabyBreathe box and support is provided by text message for up to 12 months postpartum. Target sample size is 880, recruiting across midwifery services at four hubs in England and Scotland and through remote advertising in England, Scotland, Wales and Northern Ireland. Outcomes are collected at 6 and 12 months. The primary outcome is self-reported sustained smoking abstinence at 12 months, carbon monoxide verified. Secondary outcomes include self-reported abstinence, time to relapse, partner smoking status and quality of life. ETHICS AND DISSEMINATION: The trial was approved by the North West Preston Research Ethics committee (21/NW/0017). Dissemination will include publication in peer-reviewed journals, presentation at academic and public conferences including patient and public involvement and to policymakers and practitioners. TRIAL REGISTRATION NUMBER: ISRCTN70307341.

Systematic review: Interventions for alcohol use disorder in patients with cirrhosis or alcohol-associated hepatitis.

BACKGROUND: Alcohol use is the most important factor in determining the prognosis of patients with alcohol-related cirrhosis and alcohol-associated hepatitis. AIM: To conduct a systematic review of interventions for alcohol use disorder specific to patients with cirrhosis or alcohol-associated hepatitis. METHODS: We searched five databases between inception and November 2022. The primary outcomes were abstinence, hepatic decompensation and mortality. We included randomised and non-randomised studies. Risk of bias was assessed using validated tools. Where possible, meta-analysis was performed. RESULTS: Twenty-three studies met the inclusion criteria including six randomised trials and 17 non-randomised studies of interventions. These included 104,298 patients with a mean/median age range from 44 to 65, of whom 75% were male. Interventions included psychological therapy, pharmacological therapies, specialist clinics, patient education and low alcohol drinks. Baclofen was the only intervention to demonstrate a statistically significant impact on the primary outcomes in a randomised trial (abstinence OR: 6.3, 95% CI: 2.4-16.1). Three non-randomised studies reported reductions in episodes of hepatic decompensation that were significant in multivariate models. This was in response to psychological therapy, use of any pharmacotherapy, and use of any treatment. A meta-analysis of non-randomised studies that examined the impact of psychological therapies revealed statistically non-significant improvements in abstinence (4 studies, OR: 1.87, 95% CI: 0.38-9.23) and mortality (4 studies, OR: 0.47, 95% CI: 0.12-1.77). CONCLUSIONS: Baclofen is the only intervention with randomised trial evidence for significant benefit in patients with cirrhosis. Non-randomised studies also point to non-pharmaceutical interventions possibly improving clinical outcomes.

Biochemical Verification of Tobacco-Use as an Inclusion Criterion in Smoking Cessation Trials- Lessons From the Cessation of Smoking Trial in the Emergency Department.

INTRODUCTION: Biochemical verification of smoking status prior to recruitment into smoking cessation trials is widely used to confirm smoking status, most commonly using exhaled carbon monoxide (CO). There is variation in the level of CO used as a biochemical inclusion criterion, and thus the possibility for people reporting to be current smokers to be incorrectly excluded from trials. METHODS: As part of the Cessation of Smoking Trial in the Emergency Department, people attending the Emergency Department (ED) who reported being current daily smokers underwent CO testing to confirm eligibility. Elective semi-structured interviews were undertaken with the researchers who recruited participants. As part of the interviews, researchers were asked their views and experiences with CO testing. RESULTS: Of the 1320 participants who reported being current daily smokers and underwent CO testing, 300 (22.7%) blew a CO reading of 7 ppm or less and were excluded from taking part. Possible explanations offered by researchers for participants blowing low CO readings were (1) long wait times in the ED, therefore a long period having elapsed since people had last smoked and (2) patients having reduced smoking for the period before the ED attendance due to ill health. CONCLUSIONS: Biochemical verification has the potential to improve internal validity of smoking cessation for inclusion in trials, but at the cost of reduced generalisability through exclusion of participants who would receive the intervention if it were implemented in practice. We would recommend researchers carefully consider whether it is appropriate and necessary to include biochemical verification as an inclusion criterion.

An Automated, Online Feasibility Randomized Controlled Trial of a Just-In-Time Adaptive Intervention for Smoking Cessation (Quit Sense).

INTRODUCTION: Learned smoking cues from a smoker's environment are a major cause of lapse and relapse. Quit Sense, a theory-guided Just-In-Time Adaptive Intervention smartphone app, aims to help smokers learn about their situational smoking cues and provide in-the-moment support to help manage these when quitting. METHODS: A two-arm feasibility randomized controlled trial (N = 209) to estimate parameters to inform a definitive evaluation. Smoker's willing to make a quit attempt were recruited using online paid-for adverts and randomized to "usual care" (text message referral to NHS SmokeFree website) or "usual care" plus a text message invitation to install Quit Sense. Procedures, excluding manual follow-up for nonresponders, were automated. Follow-up at 6 weeks and 6 months included feasibility, intervention engagement, smoking-related, and economic outcomes. Abstinence was verified using cotinine assessment from posted saliva samples. RESULTS: Self-reported smoking outcome completion rates at 6 months were 77% (95% CI 71%, 82%), viable saliva sample return rate was 39% (95% CI 24%, 54%), and health economic data 70% (95% CI 64%, 77%). Among Quit Sense participants, 75% (95% CI 67%, 83%) installed the app and set a quit date and, of those, 51% engaged for more than one week. The 6-month biochemically verified sustained abstinence rate (anticipated primary outcome for definitive trial), was 11.5% (12/104) among Quit Sense participants and 2.9% (3/105) for usual care (adjusted odds ratio = 4.57, 95% CIs 1.23, 16.94). No evidence of between-group differences in hypothesized mechanisms of action was found. CONCLUSIONS: Evaluation feasibility was demonstrated alongside evidence supporting the effectiveness potential of Quit Sense. IMPLICATIONS: Running a primarily automated trial to initially evaluate Quit Sense was feasible, resulting in modest recruitment costs and researcher time, and high trial engagement. When invited, as part of trial participation, to install a smoking cessation app, most participants are likely to do so, and, for those using Quit Sense, an estimated one-half will engage with it for more than 1 week. Evidence that Quit Sense may increase verified abstinence at 6-month follow-up, relative to usual care, was generated, although low saliva return rates to verify smoking status contributed to considerable imprecision in the effect size estimate.

Cessation of smoking trial in the emergency department (CoSTED): protocol for a multicentre randomised controlled trial.

INTRODUCTION: Attendees of emergency departments (EDs) have a higher than expected prevalence of smoking. ED attendance may be a good opportunity to prompt positive behaviour change, even for smokers not currently motivated to quit. This study aims to determine whether an opportunist smoking cessation intervention delivered in the ED can help daily smokers attending the ED quit smoking and is cost-effective. METHODS AND ANALYSIS: A two-arm pragmatic, multicentred, parallel-group, individually randomised, controlled superiority trial with an internal pilot, economic evaluation and mixed methods process evaluation. The trial will compare ED-based brief smoking cessation advice, including provision of an e-cigarette and referral to local stop smoking services (intervention) with the provision of contact details for local stop smoking services (control). Target sample size is 972, recruiting across 6 National Health Service EDs in England and Scotland. Outcomes will be collected at 1, 3 and 6 months. The primary outcome at 6 months is carbon monoxide verified continuous smoking abstinence. ETHICS AND DISSEMINATION: The trial was approved by the South Central-Oxford B Research Committee (21/SC/0288). Dissemination will include the publication of outcomes, and the process and economic evaluations in peer-reviewed journals. The findings will also be appropriately disseminated to relevant practice, policy and patient representative groups. TRIAL REGISTRATION NUMBER: NCT04854616; protocol V.4.2.

Comparing the Effects of the EU- Versus the US-JUUL Pod in a Sample of UK Smokers: Nicotine Absorption, Satisfaction, and Other Nicotine-Related Subjective Effects.

INTRODUCTION: Pod Vaping Devices (PVD) such as JUUL have become extremely popular in the United States although their uptake and use in the United Kingdom remain lower. A key difference between the United States and the United Kingdom is the nicotine strength legally permitted, typically 59 mg/mL in the United States but capped at 20 mg/mL in the United Kingdom and European Union. This may limit the ability of EU vaping devices to deliver satisfactory nicotine levels. The primary aim was to compare the EU- (18 mg/mL nicotine strength) with the U.S.-JUUL (59 mg/mL) on daily smokers' subjective experiences, craving relief, and blood nicotine levels. AIMS AND METHODS: Double-blind, counterbalanced within-participants design with two conditions: 18 mg/mL versus 59 mg/mL. On two separate occasions, UK smokers (N =19, 10 males, 9 females) vaped ad libitum for 60 mins and provided blood samples at baseline 5, 15, 30, and 60 min. Subjective effects (incl. satisfaction) were measured at 10 and 60 min and, craving and withdrawal symptoms (WS) at baseline, 10 and 60 min. RESULTS: Satisfaction did not differ between conditions. There was a significant interaction between Time and Nicotine concentration for Nicotine Hit (p = .045). Mean self-report of Nicotine Hit increased under the use of the 59 mg/mL from 10 to 60 min and decreased under the 18 mg/mL. Participants reported higher Throat Hits following use of the 59 mg/mL (p = .017). There were no differences in other subjective effects including craving, WS relief (ps > .05). Liquid consumption was doubled under the 18 versus the 59 mg/mL (p = .001) and nicotine boost was significantly higher in the 59 mg/mL at all time-points (p ≤ .001). CONCLUSIONS: The results did not support our hypotheses that satisfaction, craving, and withdrawal reduction would be higher with the 59 mg/mL JUUL. This could be because of the doubling of liquid consumption in the 18 mg/mL. Whether satisfaction and craving relief persist over the longer-term outside of the lab remains to be determined. IMPLICATIONS: In a 60-min ad-lib vaping session, the EU-JUUL was found to produce comparable satisfaction, craving- and withdrawal relief as the U.S.-JUUL in this sample of UK smokers. These findings could suggest that the higher nicotine concentrations available in PVDs in the United States are not necessary for providing satisfaction and improving craving and WS. However, this was at the expense of a considerable increase in liquid consumption indicative of compensatory puffing.

A qualitative process evaluation of social recovery therapy for enhancement of social recovery in first-episode psychosis (SUPEREDEN3).

BACKGROUND: Many individuals with first-episode psychosis experience severe and persistent social disability despite receiving specialist early intervention. The SUPEREDEN3 trial assessed whether augmenting early intervention in psychosis services with Social Recovery Therapy (SRT) would lead to better social recovery. AIMS: A qualitative process evaluation was conducted to explore implementation and mechanisms of SRT impact from the perspective of SUPEREDEN3 participants. METHOD: A subsample of SUPEREDEN3 trial participants (n = 19) took part in semi-structured interviews, which were transcribed verbatim and analysed thematically. Trial participants were early intervention service users aged 16-35 years with severe and persistent social disability. Both SRT plus early intervention and early intervention alone arm participants were interviewed to facilitate better understanding of the context in which SRT was delivered and to aid identification of mechanisms specific to SRT. RESULTS: The six themes identified were used to generate an explanatory model of SRT's enhancement of social recovery. Participant experiences highlight the importance of the therapist cultivating increased self-understanding and assertively encouraging clients to face feared situations in a way that is perceived as supportive, while managing ongoing symptoms. The sense of achievement generated by reaching targets linked to personally meaningful goals promotes increased self-agency, and generates hope and optimism. CONCLUSIONS: The findings suggest potentially important processes through which social recovery was enhanced in this trial, which will be valuable in ensuring the benefits observed can be replicated. Participant accounts provide hope that, with the right support, even clients who have persistent symptoms and the most severe disability can make a good social recovery.

Toward an ontology of identity-related constructs in addiction, with examples from nicotine and tobacco research.

BACKGROUND AND AIMS: We aimed to create a basic set of definitions and relationships for identity-related constructs, as part of the Addiction Ontology and E-Cigarette Ontology projects, that could be used by researchers with diverse theoretical positions and so facilitate evidence synthesis and interoperability. METHODS: We reviewed the use of identity-related constructs in psychological and social sciences and how these have been applied to addiction with a focus on nicotine and tobacco research. We, then, used an iterative process of adaptation and review to arrive at a basic set of identity-related classes with labels, definitions and relationships that could provide a common framework for research. RESULTS: We propose that 'identity' be used to refer to 'a cognitive representation by a person or group of themselves', with 'self-identity' referring to an individual's identity and 'group identity' referring to an identity held by a social group. Identities can then be classified at any level of granularity based on the content of the representations (e.g. 'tobacco smoker identity', 'cigarette smoker identity' and 'vaper identity'). We propose distinguishing identity from 'self-appraisal' to capture the distinction between the representation of oneself (e.g. as an 'ex-smoker') and (i) the importance and (ii) the positive or negative evaluation that we attach to what is represented. We label an identity that is appraised as enduring as a 'core identity', related to 'strong identity' because of the appraisal as important. Identities that are appraised positively or negatively involve 'positive self-appraisal' and 'negative self-appraisal' respectively. This allows us to create 'logically defined classes' of identity by combining them (e.g. 'positive core cigarette smoker identity' to refer to a cigarette smoker self-identity that is both positive and important). We refer to the totality of self-identities of a person as a 'composite self-identity'. CONCLUSIONS: An ontology of identity constructs may assist in improving clarity when discussing theories and evidence relating to this construct in addiction research.

An exploration of flavours in studies of e-cigarettes for smoking cessation: secondary analyses of a systematic review with meta-analyses.

AIMS: To estimate associations between e-cigarette flavour and smoking cessation and study product use at 6 months or longer. METHODS: Secondary analysis of data from a living systematic review, with meta-analyses and narrative synthesis, incorporating data up to January 2022. Included studies provided people who smoked combustible cigarettes with nicotine e-cigarettes for the purpose of smoking cessation compared with no treatment or other stop smoking interventions. Measurements included smoking cessation and study product use at 6 months or longer reported as risk ratios (RR) with 95% confidence intervals (CI); and flavour use at any time-points. RESULTS: We included 16 studies (n = 10 336); 14 contributed to subgroup analyses and 10 provided participants with a choice of e-cigarette flavour. We judged nine, five and two studies at high, low and unclear risk of bias, respectively. Subgroup analyses showed no clear associations between flavour and cessation or product use. In all but one analysis, tests for subgroup differences resulted in I2 values between 0 and 35%. In the comparison between nicotine e-cigarettes and nicotine replacement therapy (NRT) (I2  = 65.2% for subgroup differences), studies offering tobacco flavour e-cigarettes showed evidence of a greater proportion of participants still using at 6 months or longer (RR = 3.81; 95% CI = 1.45-10.05; n = 1181; I2  = 84%), whereas there was little evidence for greater 6-month use when studies offered a choice of flavours (RR = 1.44; 95% CI = 0.80-2.56; n = 454; I2  = 82%). However, substantial statistical heterogeneity within subgroups makes interpretation of this result unclear. In the 10 studies where participants had a choice of flavours, and this was tracked over time, some switching between flavours occurred, but there were no clear patterns in flavour preferences. CONCLUSIONS: There does not appear to be a clear association between e-cigarette flavours and smoking cessation or longer-term e-cigarette use, possibly due to a paucity of data. There is evidence that people using e-cigarettes to quit smoking switch between e-cigarette flavours.

A Pilot E-Cigarette Voucher Scheme in a Rural County of the United Kingdom.

INTRODUCTION: E-Cigarette voucher schemes have been piloted across the UK to support populations to quit smoking. This short report evaluates a scheme that targets vulnerable and disadvantaged smokers who had failed to quit smoking by other means. METHODS: Descriptive summary evaluation of service data on smoking outcomes and qualitative data from selected participants, as "key-informants" (n = 4) and key stakeholders (stop smoking staff, vape shop staff, and general practitioners [GPs]). RESULTS: In total, 668 participants were referred to the scheme, and 340 participants redeemed a voucher. By intention to treat analysis (ITT) 143/668 (21%) were recorded as quit smoking at 4 weeks. At 12 weeks, 7.5% of participants had quit, by ITT. Overall, the pilot project was well received by clients as it offered an affordable route into vaping for smoking cessation. GPs supported the scheme and appreciated being able to offer an alternative to entrenched smokers. CONCLUSIONS: The scheme shows promise in supporting entrenched smokers to quit smoking. The offer of similar voucher schemes across the UK suggests the potential to reduce overall smoking prevalence and associated morbidity and mortality. IMPLICATIONS: Working with GPs in a deprived area, it was possible to set-up a vape shop voucher scheme for smoking cessation. Patients with comorbidities who had tried and failed to quit smoking previously were referred to receive a vape shop voucher to be redeemed for an initial starter kit, alongside support from the stop smoking service. This innovative scheme enabled 42% of entrenched smokers who redeemed a voucher to successfully quit smoking within 4 weeks.