E-cigarettes to Augment Stop Smoking In-person Support and Treatment with Varenicline (E-ASSIST): A
Friday, March 17, 2023
Posted by: Natalia Gromov
Tattan-Birch
H, Kock L, Brown J, Beard E, Bauld L, West R, Shahab L.
E-cigarettes to Augment
Stop Smoking In-person Support and Treatment with Varenicline (E-ASSIST): A
Pragmatic Randomized Controlled Trial.
Nicotine Tob Res. 2023 Feb 9;25(3):395-403. doi: 10.1093/ntr/ntac149. PMID:
35738868; PMCID: PMC9384384.
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.
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