E-cigarettes and dual nicotine replacement therapy for smoking cessation.

Introduction:
This text is a study protocol for a three-arm, pragmatic, community-based randomized controlled trial investigating the effectiveness, safety, and acceptability of combining nicotine salt e-cigarettes with cytisine, compared to nicotine salt e-cigarettes or cytisine only, on smoking abstinence at six months. The trial is designed to provide real-world evidence on the effectiveness of combining nicotine salt e-cigarettes with cytisine for smoking cessation in a country with strong tobacco control policy.

Key Points:

* The study is a pragmatic, community-based, investigator-blinded, randomized superiority trial with a 3:3:2 ratio.
* Participants will be randomized to one of three trial groups: e-cigarettes (closed pod system, 3% nicotine salt, tobacco flavor) plus cytisine; e-cigarettes alone; or cytisine alone.
* All groups will receive a six-month, text-message-based behavioral support program.
* The primary outcome is self-reported, biochemically verified, continuous abstinence at six months post-quit date.
* Secondary outcomes include self-reported continuous abstinence, 7-day point prevalence abstinence, cigarettes smoked per day, withdrawal and urge to smoke, time to (re)lapse, treatment use and compliance, treatment crossover, dual-use, use of other cessation products, change in e-cigarette products, continuation of product use, acceptability, change in health state, health-related quality of life, change in body mass index, adverse events, and cost per quitter.
* Recruitment will utilize multi-media advertising, targeting specific subgroups with disproportionately higher smoking prevalence.
* Participants will be excluded if they have a strong preference to use or not use either product in their quit attempt or if they have another member of their household already enrolled in the study.
* The trial is single-blind, with participants aware of their intervention allocation, and data collection includes questions specific to participants’ use of their allocated treatment.

Main Message:
The main message of this text is the introduction of a study protocol for a trial investigating the effectiveness of combining nicotine salt e-cigarettes with cytisine for smoking cessation. The trial is designed to provide real-world evidence on the effectiveness of this combination and inform practice and policy. The trial's pragmatic design allows for the inclusion of a diverse population and reflects the complexities of real-world decision-making, enhancing the generalizability of the findings.

Benowitz NL. E-cigarettes and dual nicotine replacement therapy for smoking cessation. The Lancet Respiratory medicine. 2020;8(1):7-8. doi:10.1016/S2213-2600(19)30308-X