CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 240 enrolled
Drug / intervention
Continue-smoking +5 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04019626
NCT04019626N/ACompleted
CompareCT.gov

An Open-label, Parallel Study to Assess Tobacco-related Biomarkers of Exposure, Biomarkers of Potential Harm, and Nicotine Uptake During a 56-day Switch to Myblu E-cigarettes in Adult Smokers

Fontem Ventures BV·interventional·Posted Jul 15, 2019·Updated Jun 30, 2021

In Brief

A clinical study evaluating Continue-smoking, myblu Tobacco 2.5%, and 4 other interventions for Healthy Volunteers. Completed, enrolled 240 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJul 15, 2019
Enrollment StartMar 1, 2019
Primary CompletionDec 31, 2020
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 7.0 years ago

Interventions

Continue-smokingother

Ad-libitum use of subjects' usual brand combustible cigarette

myblu Tobacco 2.5%other

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

myblu Tobacco 4.0%other

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

myblu Honeymoon 2.5%other

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

myblu Honeymoon 4.0%other

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

JUUL 5%other

Ad-libitum use of JUUL 5% e-cigarette