At a glance
ClinicalIndex Comparison RecordN/ACompleted· 154 enrolled
Drug / intervention
Oral tobacco-derived nicotine product (OTDN)other
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.
A Randomized, Controlled, Parallel Group Clinical Study of Cigarette Smokers Using an Innovative Oral Tobacco-derived Nicotine Product to Determine Impact on Cigarette Consumption and Biomarkers of Exposure
In Brief
A clinical study evaluating Oral tobacco-derived nicotine product (OTDN) for Tobacco Use. Completed, enrolled 154 participants across 3 sites.
Detailed Summary
The purpose of this study was to estimate changes in biomarkers of exposure (BOE) in adult cigarette smokers using an oral tobacco-derived nicotine (OTDN) product relative to adult smokers who continue smoking exclusively.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTobacco Use
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartAug 2013
Primary CompletionNov 2013
First PostedSep 2019
TodayJul 2026
First PostedSep 6, 2019
Enrollment StartAug 27, 2013
Primary CompletionNov 26, 2013
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 6.8 years ago
Interventions
Oral tobacco-derived nicotine product (OTDN)other