Effectiveness, safety and cost-effectiveness of vaporized nicotine products versus nicotine replacement therapy for tobacco smoking cessation in a low-socioeconomic status australian population: a study protocol for a randomized controlled trial.

Introduction:
This text is a study protocol for a randomized controlled trial (RCT) that aims to evaluate the effectiveness, safety, and cost-effectiveness of vaporized nicotine products (VNPs) compared to nicotine replacement therapy (NRT) for smoking cessation in a low socioeconomic status australian population. The study will compare VNPs (pod and tank devices) with NRT (gum or lozenge) and will provide minimal behavioral support via text messages. The primary outcome is 6-month continuous abstinence verified by carbon monoxide breath test of ≤5ppm at 7-month follow-up. Safety and cost-effectiveness of VNPs versus NRT will also be evaluated.

Key Points:

* This is a two-arm, open-label, superiority, parallel group, randomized controlled trial (RCT) with allocation concealment and blinded outcome assessment.
* Participants will be people who smoke daily, are interested in quitting, and receive a government pension or allowance (N = 1058).
* Participants will be randomized to receive 8 weeks of free: VNPs, with pod (40 mg/mL nicotine salt) and tank device (18 mg/mL freebase nicotine) in mixed flavors; or NRT (gum or lozenge; 4 mg).
* all participants will receive daily text message behavioral support for 5 weeks.
* assessments will be undertaken by telephone at baseline, with three follow-up calls to ascertain smoking status, treatment adherence, and adverse events.
* The primary outcome is 6-month continuous abstinence verified by carbon monoxide breath test of ≤5ppm at 7-month follow-up.
* Safety and cost-effectiveness of VNPs versus NRT will also be evaluated.

Main Message:
The main message of this text is that this RCT aims to evaluate the effectiveness, safety, and cost-effectiveness of VNPs compared to NRT for smoking cessation in a low socioeconomic status australian population. This is important because smoking rates remain high in this population, and there is a lack of evidence on effective smoking cessation interventions. The study will provide valuable information on the potential benefits and risks of using VNPs for smoking cessation in this population.

howard BC, McRobbie h, Petrie D, et al. Effectiveness, safety and cost-effectiveness of vaporized nicotine products versus nicotine replacement therapy for tobacco smoking cessation in a low-socioeconomic status australian population: a study protocol for a randomized controlled trial. Trials. 2022;23(1):777. doi:10.1186/s13063-022-06644-8