A combination of reduced-harm, non-cigarette nicotine products could provide a small improvement to a person’s smoking cessation efforts, according to a new study.
A team of investigators from the University of Auckland’s National Institute for Health Innovation found that combining nicotine patches with an electronic cigarette which includes nicotine could slightly improve a person’s nicotine cigarette smoking cessation with no risk of serious, short-term harm.
The findings, reported by Natalie Walker, PhD, and her fellow New Zealand colleagues, is the first of the team’s knowledge to assess second-generation e-cigarettes for smoking cessation within a general population, using the selection of e-cigarettes and e-liquid based on advice from vaping retailers.
Walker and her team noted about 7 clinical trials have previously investigated the efficacy and effectiveness of e-cigarettes for smoking cessation, showing an overall net benefit. But only 4 included a primary outcome of six-month smoking abstinence, and just 2 tested a second-generation e-cigarette device.
This limited data comes in spite of the fact that many countries use nicotine-based e-cigarettes to aid in smoking cessation.
The pragmatic, three-arm, parallel trial included adult smokers who were naïve to e-cigarettes and were motivated to quit smoking. All participants were recruited from the general population with national media advertising.
The 1124 recruited participants were randomized 1:4:4 to 14 weeks of 21 mg, 24h nicotine patches (n = 125), patches plus an 18 mg/L nicotine e-cigarette (n = 500), or patches plus a nicotine-free e-cigarette (n = 499).
Participants were also offered 6 weeks of telephone-based behavioral support as part of their cessation efforts. Investigators advised participants use 1 daily patch, with e-cigarette use as and when necessary or desired.
Walker and colleagues sought a primary outcome of exhaled carbon monoxide-verified continuous smoking abstinence at 6 months following the agreed quit date. Secondary outcomes included continuous abstinence, seven-day point prevalence abstinence, relapse, and more, at months 1, 3, 6, and 12 months.
At trial’s end, 62 (50%) of the patches-only participants had withdrawn or were lost to follow-up. One-third of patients in the patches plus nicotine e-cigarette group (32%) and patches plus nicotine-free e-cigarette group (33%).
About 7% of the patches plus nicotine e-cigarette group had carbon monoxide-verified continuous abstinence at 6 months, compared to 4% of participants in the patches plus nicotine-free e-cigarette group, and 2% in the patches-only group. Total serious adverse events among the groups were 18, 27, and 4, respectively.
Investigators observed no significant between-group differences in serious adverse events, non being treatment-related.
They also noted that self-reported quit rates at all timepoints of the trial were in favor of participants who took patches plus nicotine e-cigarettes, explaining the reduced significance of benefit for the combination cessation strategy due to smaller participant size.
That said, when looking at continuous abstinence from smoking, nicotine patches plus nicotine e-cigarettes were confirmed to be associated with long-term smoking cessation in 3-7 more smokers per 100 than alternative methods.
“Our findings are consistent with the current findings of the Cochrane review of e-cigarettes for smoking cessation and contribute to the growing body of evidence from randomized trials on the efficacy, effectiveness and safety of e-cigarettes for smoking cessation,” investigators wrote.
Walker and colleagues called for future e-cigarette trials which focused on use alone or in combination with common cessation support.
The study, “Nicotine patches used in combination with e-cigarettes (with and without nicotine) for smoking cessation: a pragmatic, randomised trial
,” was published online in The Lancet Respiratory Medicine