Abstract
Background: Vaporized nicotine products (VNPs) are more effective than nicotine replacement therapy (NRT) for smoking cessation in general populations, but their effectiveness among low socioeconomic groups is largely unknown. Objective: To examine whether VNPs are more effective than NRT for smoking cessation among people experiencing social disadvantage. Design: Two-group, open-label, randomized trial with blinded outcome ascertainment. (Australian New Zealand Clinical Trials Registry ACTRN12621000076875) Setting: Australia, between March 2021 and December 2022. Participants: 1045 adults who smoked daily, were willing to quit smoking, and were receiving a government pension/allowance (proxy for social disadvantage). Intervention: Participants were randomly assigned (1:1) to either a free 8-week supply of NRT or VNPs, and all participants received text-message support. Measurements: The primary outcome was 6-month continuous smoking abstinence verified using a carbon monoxide breath test at 7-month follow-up. Analysis included randomly assigned participants in accordance with Russell Standard criteria and the intention-to-treat principle. Results: Among 1045 randomly assigned participants, 866 (82.9%) completed final follow-up. The verified 6-month continuous abstinence rate was 9.6% (50 of 523) in the NRT group and 28.4% (148 of 522) in the VNP group (posterior risk difference estimate, 18.7% [95% credible interval, 14.1% to 23.3%]; >99% posterior probability that VNP is superior). Self-reported adverse events occurred less frequently in the VNP group (355 events among 237 participants) compared with the NRT group (442 events among 278 participants; incident rate ratio, 0.75 [95% CI, 0.65 to 0.88]; P < 0.001). Limitations: Biochemical verification method tested short-term exposure to cigarette smoke. Conclusion: Findings indicate that VNPs were more effective than NRT for smoking cessation in this population. Given the challenges for cessation among these socially disadvantaged populations, VNPs present a promising treatment option for this priority group. Primary Funding Source: Australian National Health and Medical Research Council.