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

NCT05855343 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-03-19

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Foundation for a Smoke Free World INC

    collaborator OTHER

  • Rose Research Center, LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-14
Primary Completion
2023-09-05
Completion
2023-12-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05855343 on ClinicalTrials.gov