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A Study to Assess Tobacco-related Biomarkers of Exposure in Smokers Using myBlu E-cigarettes

NCT04019626 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2021-06-30

Study results available
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Summary

The purpose of this study is to assess changes in exposure to selected harmful and potentially harmful substances related to tobacco/nicotine use when adult smokers switch from their usual brand of combustible cigarettes to the myblu e-cigarette, for up to 56 days. This study is designed as an open-label, partially-randomized, parallel-arm, multi-site study in healthy adult smokers.

Some subjects will be selected to take part in additional procedures as part of a pharmacokinetics (PK) sub-study.

Conditions

  • Healthy Volunteers

Interventions

OTHER

Continue-smoking

Ad-libitum use of subjects' usual brand combustible cigarette

OTHER

myblu Tobacco 2.5%

Ad-libitum use of myblu e-cigarette with Tobacco flavor 2.5% nicotine

OTHER

myblu Tobacco 4.0%

Ad-libitum use of myblu e-cigarette with Tobacco flavor 4.0% nicotine

OTHER

myblu Honeymoon 2.5%

Ad-libitum use of myblu e-cigarette with Honeymoon flavor 2.5% nicotine

OTHER

myblu Honeymoon 4.0%

Ad-libitum use of myblu e-cigarette with Honeymoon flavor 4.0% nicotine

OTHER

JUUL 5%

Ad-libitum use of JUUL 5% e-cigarette

Sponsors & Collaborators

  • Fontem Ventures BV

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2020-12-31
Completion
2020-12-31

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 NCT04019626 on ClinicalTrials.gov