Combining reduced-harm nicotine products may improve smoking cessation
Combining reduced-harm nicotine products can lead to improvement in smoking cessation without short-term harm, according to a study published in The Lancet Respiratory Medicine.
“When looking at continuous abstinence from smoking, provision of patches plus a nicotine e-cigarette resulted in three to seven more smokers per 100 quitting long term than with patches plus a nicotine-free e-cigarette,” Natalie Walker, PhD, of the National Institute for Health Innovation at the School of Population Health in New Zealand, and colleagues wrote.
In New Zealand, 1,124 adults who smoked tobacco and were motivated to quit were recruited through national media advertising and randomly assigned to one of three interventions: patches only (n = 125), patches plus nicotine e-cigarettes (n = 500) or patches plus nicotine-free e-cigarettes (n = 499). Participants were given a 14-week supply of their allocated treatment, including 21 mg, 24-hour nicotine patches for the patches-only group and a second-generation eVOD starter kit with e-liquid containing a masked nicotine content of 0 mg/mL or 19 mg/mL for the patches plus e-cigarette groups.
Participants in the patches-only group were advised to use one nicotine patch per day and the patches plus e-cigarette groups were advised to use their device when necessary or desired.
The primary outcome of this study was continuous smoking cessation at 6 months after the agreed-upon quit date. Secondary outcomes were assessed at the quit date, 1, 3, 6 and 12 months after the agreed quit date with continuous cessation.
At 6 months, 34% of participants in the patches-only group and 30% of participants in the patches plus e-cigarette groups were lost to follow-up. Sixteen percent of participants in the patches-only group withdrew from the study, as did 2% of those in the patches plus nicotine e-cigarette group and 1% of those in the patches plus nicotine-free e-cigarette group.
In the remaining 125 participants in the patches-only group, 15% switched to e-cigarette use during the trial and 11% of the 499 participants in the patches plus nicotine-free e-cigarette group switched to nicotine e-cigarettes.
Continuous carbon monoxide-verified smoking cessation at 6 months after the agreed quit date did not differ significantly between the patches plus nicotine e-cigarette group (7%) and the patches-only group (2%; RR = 2.92; 95% CI, 0.91-9.33). However, rates of smoking cessation at 6 months in the patches plus nicotine e-cigarette group was significantly higher than in the patches plus nicotine-free e-cigarette group (7% vs. 4%; RR = 1.75; 95% CI, 1.02-2.98).
Additionally, among those still smoking, more participants in the patches plus nicotine e-cigarette group reduced the number of cigarettes they smoked per day by 50% during a 3-month period compared with those in the patches plus nicotine-free e-cigarette group (54% vs. 46%; P = .012).
Adverse events occurred in 16 participants in the patches plus nicotine e-cigarette group, 22 participants in the patches plus nicotine-free e-cigarette group and three participants in the patches-only group. None of the adverse events were treatment-related.
“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,” the researchers wrote.
They noted, however, that the study was limited by its small sample size, higher-than-expected loss to follow-up, the inability to fully mask the nicotine content of the e-liquid and lack of a placebo group and differences in behavioral support between treatment groups.
E-cigarettes for smoking cessation
E-cigarettes may be a more attractive option than medications or patches for smokers and because treatment acceptability is important for participant adoption of treatment, this may explain the high dropout and crossover rates in the patches-only group, Neal L. Benowitz, MD, of the clinical pharmacology program in the department of Medicine at the University of California, San Francisco, wrote in an accompanying editorial.
“Despite [the study limitations], the main findings of the study, that dual treatment with e-cigarettes and nicotine patches aids smoking cessation and that quit rates are higher with nicotine e-cigarettes than with nicotine-free e-cigarettes, are robust,” Benowitz wrote. “The study supports national policies that would make nicotine e-cigarettes available to promote smoking cessation. An important therapeutic question to be answered is whether dual nicotine replacement therapy with e-cigarettes is superior to e-cigarettes alone.” – by Erin T. Welsh
Disclosures: Walker reports she received grants from the Health Research Council of New Zealand and Pfizer. Please see the study for all other authors’ relevant financial disclosures. Benowitz reports he received fees from Achieve Life Sciences and Pfizer, and he is a paid expert witness in litigation against tobacco companies.