NCT05855343

Exploratory Study of Switching From Combustible Cigarettes to the BIDI E-cigarette

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Rose Research Center, LLC · Industry
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to shed light on the importance of nicotine pharmacokinetics in switching to a reduced-harm product by fully matching the nicotine pharmacokinetics of smokers' usual brands of cigarettes. The primary objective is to ascertain the degree of smoking reduction when smokers attempt to switch to an e-cigarette that matches peak nicotine concentrations of a cigarette.

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
OTHER	BIDI Stick e-cigarette	The BIDI will be dispensed, and subjects will be instructed to use the BIDI as often as they like during the 12 week period, and to switch completely to the BIDI within 1 week. If, however, they do smoke any CC, they will also be instructed to use the BIDI immediately before each CC to relieve their craving as much as possible before smoking their usual brand. The BIDI will also be the first product that they are instructed to use each morning. Smokers will be told to try to completely substitute BIDI for CCs by the end of the first week of use.

Timeline

• Start date: 2023-02-14
• Primary completion: 2023-09-05
• Completion: 2023-12-05
• First posted: 2023-05-11
• Last updated: 2024-03-19

Locations

2 sites across 1 country: United States