E-cigarettes to Augment Stop Smoking In-person Support and Treatment With Varenicline (E-ASSIST): A Pragmatic Randomized Controlled Trial

Abstract

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.

Multiple Pharmacotherapy Adaptations for Smoking Cessation Based on Treatment Response in Black Adults Who Smoke

“…Among Black adults who smoke in a recent population-level study, 78.8% were interested in quitting smoking in 2018 and 2019, 55.8% made a past year quit attempt, 23.2% with nicotine replacement therapy, 8.7% with varenicline or bupropion, and 1.5% to 5.9% with behavioral support, yet only 5.2% achieved cessation. Efforts to address unmet social needs among Black adults who smoke and adults with low income who smoke and a focus on tobacco harm reduction among people who smoke and are unwilling or unable to quit have shown promise and are important areas for future study …”

A Systematic Review Investigating Associations Between E-Cigarette Use Among Former Cigarette Smokers and Relapse to Smoking Cigarettes

“…Of the 214 studies that were eligible for inclusion in the larger systematic review, 28 studies reported outcomes related to relapse to smoking cigarettes. Among these 28 eligible studies, one study was an RCT, 21 and 10 were observational studies [18][19][20][22][23][24][25][26][27][28] that adjusted for gender, age, and race/ethnicity between groups (ie, adjusted for key demographic characteristics). These 10 studies were included in the qualitative synthesis of evidence.…”

“…28 One study did not define their study populations by age, but instead sampled participants who were attending stop smoking services. 21 Although RCTs were considered the highest level of evidence, only one RCT was identified and subsequently adjusted studies were included in the qualitative review. In addition to the demographic characteristics specified, most studies included further adjustments with varying combinations of other micro, meso, and macro covariates (eg, the presence of a tobacco user at home, highest parental education, and exposure to tobacco advertisements).…”

“…Among the 11 included studies that examined relapse to cigarette smoking, 3 studies evaluated the association between regular e-cigarette use and relapse to cigarette smoking 21,24,27 , six studies evaluated non-regular e-cigarette use and relapse to cigarette smoking, 19,20,23,25,26,28 and two studies evaluated the association between both regular and non-regular e-cigarette use and relapse to cigarette smoking. 18,22 Of the 5 studies that evaluated the association between regular e-cigarette use and relapse to smoking, one study was an RCT in which e-cigarettes were administered to current-established cigarette smokers as part of the intervention.…”

“…18,22 Of the 5 studies that evaluated the association between regular e-cigarette use and relapse to smoking, one study was an RCT in which e-cigarettes were administered to current-established cigarette smokers as part of the intervention. 21 These participants were considered to be regular e-cigarette users in terms of outcomes reported within the defined timeframes of the study. Three 22,27,29 of the remaining 4 studies that evaluated regular e-cigarette use applied daily and nondaily use as the definition of regular e-cigarette use, reported as separate categories of users.…”