A Pragmatic Randomized Comparative Trial of e-Cigarettes and Other Nicotine Products for Quitting or Long-Term Substitution in Smokers

Introduction
Tobacco harm reduction has potential to improve individual and population health. However, little research exists on low-intensity interventions, such as encouraging longer-term NRT or e-cigarette use. We aimed to determine whether: (1) encouraging use of nicotine products as long-term tobacco substitutes is more effective for smoking abstinence than standard treatment, and (2) offering e-cigarettes is more effective than NRT.

Methods
An open-label, parallel-group randomized trial was conducted in Australia between 2014 and 2015, with 1563 adult daily smokers, randomized to: (A) standard cessation advice and NRT: advice to use NRT short-term, (B) quit or substitute advice and NRT: advice to use NRT as a longer-term substitute for smoking if required to maintain smoking cessation, or (C) Quit or substitute advice and NRT and/or e-cigarettes. Participants were offered an initial supply of products they could then purchase for up to 7 months. The primary outcome was self-reported continuous smoking abstinence at 7 months. Point prevalence, dual use, and cigarette reduction were secondary outcomes.

Results
At 7 months, 2.8% (N = 9) of group A (N = 324) were abstinent, compared with 1.8% (N = 11) in B (N = 620) and 1.3% (N = 8) in C (N = 619) (adjusted odds ratio [ORs]: B vs. A 0.66, 95% confidence interval [CI]: 0.27−1.63; C vs. A 0.46, 95% CI: 0.17−1.21; C vs. B 0.69, 95% CI 0.27–1.73). There were no suspected unexpected serious adverse reactions associated with trial products.

Conclusion
A free trial of NRT and first generation e-cigarettes and advice on long-term substitution was no better for smoking abstinence than usual care.