Study protocol for a randomised controlled trial of electronic cigarettes versus nicotine patch for smoking cessation

Area of Science:

• Public Health
• Clinical Trials
• Nicotine Addiction Research

Background:

• Electronic cigarettes (e-cigarettes or electronic nicotine delivery systems [ENDS]) deliver vaporized nicotine and other substances.
• E-cigarettes are increasingly used for smoking cessation, but robust evidence on efficacy and safety is lacking.
• This study protocol outlines a randomized controlled trial to evaluate e-cigarettes for smoking cessation.

Purpose of the Study:

• To assess the efficacy and safety of e-cigarettes as a smoking cessation aid compared to nicotine patches.
• To provide evidence for international policy and regulation regarding e-cigarette use.
• To determine if e-cigarettes can serve as a viable alternative to standard nicotine replacement therapies.

Main Methods:

• A parallel-group, 3-arm, randomized controlled trial.
• Participants (aged ≥18 years in Auckland, NZ) were randomized to nicotine e-cigarettes, placebo e-cigarettes, or nicotine patches (21 mg).
• Behavioral support was provided by the NZ Quitline to all participants.

Main Results:

• Primary outcome is biochemically verified continuous abstinence at six months post-quit day.
• The study is powered to detect differences in abstinence rates between nicotine e-cigarettes and nicotine patches, and between nicotine and placebo e-cigarettes.
• Sample size is 657 participants to provide 80% power.

Conclusions:

• This trial will contribute crucial data to the ongoing debate on e-cigarette regulation and availability.
• If proven effective and safe, e-cigarettes could offer a significant new option for smokers aiming to quit.
• Findings will guide public health strategies and clinical recommendations for smoking cessation interventions.