E-cigarettes to Augment Stop Smoking In-person Support and Treatment with varenicline (E-ASSIST): a pragmatic randomised controlled trial.

BACKGROUND: We examined whether, in adults receiving behavioural support, offering e-cigarettes together with varenicline helps more people stop smoking cigarettes than varenicline alone. METHODS: A two-group, parallel-arm, pragmatic randomised controlled trial was conducted in six English stop smoking services from 2019-2020. Adults enrolled onto a 12-week programme of in-person one-to-one behavioural smoking cessation support (N=92) were randomised to receive either (i) a nicotine e-cigarette starter-kit alongside varenicline or (ii) varenicline alone. The primary outcome was biochemically-verified abstinence from cigarette smoking between weeks nine-to-12 post quit-date, with those lost to follow-up considered not abstinent. The trial was stopped early due to COVID-19 restrictions and a varenicline recall (92/1266 participants recruited). RESULTS: Nine-to-12-week smoking abstinence rates were 47.9% (23/48) in the e-cigarette-varenicline group compared with 31.8% (14/44) in the varenicline-only group, a 51% increase in abstinence among those offered e-cigarettes; however, the confidence interval (CI) was wide, including the possibility of no difference (risk ratio [RR]=1.51, 95%CI=0.91-2.64). The e-cigarette-varenicline group had 43% lower hazards of relapse from continuous abstinence than the varenicline-only group (hazards ratio [HR]=0.57, 95%CI=0.34-0.96). Attendance for 12 weeks was higher in the e-cigarette-varenicline than varenicline-only group (54.2% versus 36.4%; RR=1.49, 95%CI=0.95-2.47), but similar proportions of participants in both groups used varenicline daily for ≥8 weeks after quitting (22.9% versus 22.7%; RR=1.01, 95%CI=0.47-2.20). Estimates were too imprecise to determine how adverse events differed by group. CONCLUSION: Tentative evidence suggests offering e-cigarettes alongside varenicline to people receiving behavioural support may be more effective for smoking cessation than varenicline alone. IMPLICATIONS: Offering e-cigarettes to people quitting smoking with varenicline may help them remain abstinent from cigarettes, but the evidence is tentative because our sample size was smaller than planned - caused by COVID-19 restrictions and a manufacturing recall. This meant our effect estimates were imprecise, and additional evidence is needed to confirm that providing e-cigarettes and varenicline together helps more people remain abstinent than varenicline alone.

Cutting down, quitting and motivation to stop smoking by self-reported COVID-19 status: Representative cross-sectional surveys in England.

AIM: To examine the association of self-reported COVID-19 disease status with cutting down, past-month and past-year quit attempts and motivation to stop smoking. DESIGN AND SETTING: Repeat cross-sectional survey, representative of the adult population in England. PARTICIPANTS: Past-year smokers, n = 3338 (aged ≥ 18 years) responding between May 2020 and April 2021. MEASUREMENTS: Outcomes were (i) currently cutting down, (ii) having made a quit attempt in the past month, (iii) having made a quit attempt in the past year and (iv) motivation to stop smoking. The explanatory variable was self-reported COVID-19 disease status (belief in never versus ever had COVID-19). Covariates included age, sex, occupational grade, region, children in the household, alcohol use and survey month. FINDINGS: Of past-year smokers, 720 (21.6%) reported past-COVID-19 infection and 48 (1.4%) reported current COVID-19 infection. In adjusted analyses, rates of currently cutting down [adjusted odds ratio (aOR) = 1.12, 95% confidence interval (CI) = 0.93-1.34], past-year quit attempts (aOR = 0.99, 95% CI = 0.82-1.19) and motivation to stop smoking (aOR = 1.04, 95% CI = 0.89-1.23) were comparable in those who did and did not report ever having had COVID-19. People who reported ever having had COVID-19 had 39% higher odds than those without of attempting to quit in the past month, but the confidence interval contained the possibility of no difference (aOR = 1.39, 95% CI = 0.94-2.06) and for some the quit attempt may have occurred before they had COVID-19. CONCLUSION: During the first year of the COVID-19 pandemic in England, rates of reducing smoking and attempting to quit in the past year were similar in smokers who did or did not self-report ever having had COVID-19. There was also little difference in motivation to stop smoking between groups. However, causal interpretation is limited by the study design, and there is potential misclassification of the temporal sequence of infection and changes to smoking behaviour.

Heated tobacco products for smoking cessation and reducing smoking prevalence.

BACKGROUND: Heated tobacco products (HTPs) are designed to heat tobacco to a high enough temperature to release aerosol, without burning it or producing smoke. They differ from e-cigarettes because they heat tobacco leaf/sheet rather than a liquid. Companies who make HTPs claim they produce fewer harmful chemicals than conventional cigarettes. Some people report stopping smoking cigarettes entirely by switching to using HTPs, so clinicians need to know whether they are effective for this purpose and relatively safe. Also, to regulate HTPs appropriately, policymakers should understand their impact on health and on cigarette smoking prevalence. OBJECTIVES: To evaluate the effectiveness and safety of HTPs for smoking cessation and the impact of HTPs on smoking prevalence.  SEARCH METHODS: We searched the Cochrane Tobacco Addiction Group's Specialised Register, CENTRAL, MEDLINE, and six other databases for relevant records to January 2021, together with reference-checking and contact with study authors and relevant groups. SELECTION CRITERIA: We included randomised controlled trials (RCTs) in which people who smoked cigarettes were randomised to switch to exclusive HTP use or a control condition. Eligible outcomes were smoking cessation, adverse events, and selected biomarkers.  RCTs conducted in clinic or in an ambulatory setting were deemed eligible when assessing safety, including those randomising participants to exclusively use HTPs, smoke cigarettes, or attempt abstinence from all tobacco. Time-series studies were also eligible for inclusion if they examined the population-level impact of heated tobacco on smoking prevalence or cigarette sales as an indirect measure. DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methods for screening and data extraction. Our primary outcome measures were abstinence from smoking at the longest follow-up point available, adverse events, serious adverse events, and changes in smoking prevalence or cigarette sales. Other outcomes included biomarkers of harm and exposure to toxicants/carcinogens (e.g. NNAL and carboxyhaemoglobin (COHb)). We used a random-effects Mantel-Haenszel model to calculate risk ratios (RR) with 95% confidence intervals (CIs) for dichotomous outcomes. For continuous outcomes, we calculated mean differences on the log-transformed scale (LMD) with 95% CIs. We pooled data across studies using meta-analysis where possible. MAIN RESULTS: We included 13 completed studies, of which 11 were RCTs assessing safety (2666 participants) and two were time-series studies. We judged eight RCTs to be at unclear risk of bias and three at high risk. All RCTs were funded by tobacco companies. Median length of follow-up was 13 weeks. No studies reported smoking cessation outcomes.  There was insufficient evidence for a difference in risk of adverse events between smokers randomised to switch to heated tobacco or continue smoking cigarettes, limited by imprecision and risk of bias (RR 1.03, 95% CI 0.92 to 1.15; I2 = 0%; 6 studies, 1713 participants). There was insufficient evidence to determine whether risk of serious adverse events differed between groups due to very serious imprecision and risk of bias (RR 0.79, 95% CI 0.33 to 1.94; I2 = 0%; 4 studies, 1472 participants). There was moderate-certainty evidence for lower NNAL and COHb at follow-up in heated tobacco than cigarette smoking groups, limited by risk of bias (NNAL: LMD -0.81, 95% CI -1.07 to -0.55; I2 = 92%; 10 studies, 1959 participants; COHb: LMD -0.74, 95% CI -0.92 to -0.52; I2 = 96%; 9 studies, 1807 participants). Evidence for additional biomarkers of exposure are reported in the main body of the review. There was insufficient evidence for a difference in risk of adverse events in smokers randomised to switch to heated tobacco or attempt abstinence from all tobacco, limited by risk of bias and imprecision (RR 1.12, 95% CI 0.86 to 1.46; I2 = 0%; 2 studies, 237 participants). Five studies reported that no serious adverse events occurred in either group (533 participants). There was moderate-certainty evidence, limited by risk of bias, that urine concentrations of NNAL at follow-up were higher in the heated tobacco use compared with abstinence group (LMD 0.50, 95% CI 0.34 to 0.66; I2 = 0%; 5 studies, 382 participants). In addition, there was very low-certainty evidence, limited by risk of bias, inconsistency, and imprecision, for higher COHb in the heated tobacco use compared with abstinence group for intention-to-treat analyses (LMD 0.69, 95% CI 0.07 to 1.31; 3 studies, 212 participants), but lower COHb in per-protocol analyses (LMD -0.32, 95% CI -1.04 to 0.39; 2 studies, 170 participants). Evidence concerning additional biomarkers is reported in the main body of the review. Data from two time-series studies showed that the rate of decline in cigarette sales accelerated following the introduction of heated tobacco to market in Japan. This evidence was of very low-certainty as there was risk of bias, including possible confounding, and cigarette sales are an indirect measure of smoking prevalence. AUTHORS' CONCLUSIONS: No studies reported on cigarette smoking cessation, so the effectiveness of heated tobacco for this purpose remains uncertain. There was insufficient evidence for differences in risk of adverse or serious adverse events between people randomised to switch to heated tobacco, smoke cigarettes, or attempt tobacco abstinence in the short-term. There was moderate-certainty evidence that heated tobacco users have lower exposure to toxicants/carcinogens than cigarette smokers and very low- to moderate-certainty evidence of higher exposure than those attempting abstinence from  all tobacco. Independently funded research on the effectiveness and safety of HTPs is needed.  The rate of decline in cigarette sales accelerated after the introduction of heated tobacco to market in Japan but, as data were observational, it is possible other factors caused these changes. Moreover, falls in cigarette sales may not translate to declining smoking prevalence, and changes in Japan may not generalise elsewhere. To clarify the impact of rising heated tobacco use on smoking prevalence, there is a need for time-series studies that examine this association.

COVID-19, smoking, vaping and quitting: a representative population survey in England.

AIMS: To estimate (1) associations between self-reported COVID-19, hand-washing, smoking status, e-cigarette use and nicotine replacement therapy (NRT) use and (2) the extent to which COVID-19 has prompted smoking and vaping quit attempts and more smoking inside the home. DESIGN: Cross-sectional household surveys. SETTING AND PARTICIPANTS: A representative sample of the population in England from April to May 2020. The sample included 3179 adults aged ≥ 18 years. MEASUREMENTS: Participants who reported that they definitely or thought they had coronavirus were classified as having self-reported COVID-19. Participants were asked how often they wash their hands after returning home, before preparing foods, before eating or before touching their face. They were also asked whether, due to COVID-19, they had (i) attempted to quit smoking, (ii) attempted to quit vaping and (iii) changed the amount they smoke inside the home. FINDINGS: Odds of self-reported COVID-19 were significantly greater among current smokers [20.9%, adjusted odds ratio (aOR) = 1.34, 95% confidence interval (CI) = 1.04-1.73] and long-term (> 1-year) ex-smokers (16.1%, aOR = 1.33, 95% CI = 1.05-1.68) compared with never smokers (14.5%). Recent (< 1-year) ex-smokers had non-significantly greater odds of self-reported COVID-19 (22.2%, aOR = 1.50, 95% CI = 0.85-2.53). Bayes factors indicated there was sufficient evidence to rule out large differences in self-reported COVID-19 by NRT use and medium differences by e-cigarette use. With the exception of hand-washing before face-touching, engagement in hand-washing behaviours was high (> 85%), regardless of nicotine use. A minority (12.2%) of quit attempts in the past 3 months were reportedly triggered by COVID-19, and approximately one in 10 current e-cigarette users reported attempting to quit vaping because of COVID-19. CONCLUSIONS: In England, current smokers and long-term ex-smokers appear to have higher odds of self-reported COVID-19 compared with never smokers in adjusted analyses, but there were no large differences between people who used nicotine replacement therapy or e-cigarettes. Engagement in hand-washing appears to be high, regardless of nicotine or tobacco use. A minority of past-year smokers and current e-cigarette users, respectively, report attempting to quit smoking/vaping due to COVID-19.