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

AIM: To examine whether, in adults receiving behavioral support, offering e-cigarettes together with varenicline helps more people stop smoking cigarettes than varenicline alone. METHODS: A two-group, parallel arm, pragmatic randomized 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 behavioral smoking cessation support (N = 92) were randomized to receive either (1) a nicotine e-cigarette starter kit alongside varenicline or (2) varenicline alone. The primary outcome was biochemically verified abstinence from cigarette smoking between weeks 9-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 used). 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% vs. 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 that offering e-cigarettes alongside varenicline to people receiving behavioral 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 Coronavirus Disease 2019 (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.