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

Tattan-Birch, Harry; Kock, Loren; Brown, Jamie; Beard, Emma; Bauld, Linda; West, Robert; Shahab, Lion; (2022) E-cigarettes to Augment Stop Smoking In-person Support and Treatment with varenicline (E-ASSIST): a pragmatic randomised controlled trial. Nicotine & Tobacco Research 10.1093/ntr/ntac149. (In press). Green open access

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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.

Type: Article
Title: E-cigarettes to Augment Stop Smoking In-person Support and Treatment with varenicline (E-ASSIST): a pragmatic randomised controlled trial
Location: England
Open access status: An open access version is available from UCL Discovery
DOI: 10.1093/ntr/ntac149
Publisher version: https://doi.org/10.1093/ntr/ntac149
Language: English
Additional information: © The Author(s) 2022. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/).
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute of Epidemiology and Health > Epidemiology and Public Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute of Epidemiology and Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute of Epidemiology and Health > Behavioural Science and Health
URI: https://discovery.ucl.ac.uk/id/eprint/10150995
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