At a glance
ClinicalIndex Comparison RecordN/ACompleted· 231 enrolled
Drug / intervention
OTDN product 1 +2 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.
A Randomized, Controlled, Study to Evaluate Changes in Exposure to Harmful and Potentially Harmful Constituents in Adult Smokers Who Partially or Completely Switch to Oral Tobacco-derived Nicotine Products in a Clinical Setting.
In Brief
A clinical study evaluating OTDN product 1, OTDN product 2, and 1 other intervention for Tobacco Use. Completed, enrolled 231 participants across 2 sites.
Detailed Summary
The purpose of this study is to evaluate changes in exposure to selected harmful and potentially harmful constituents (HPHC) by measuring biomarkers in adult smokers who partially or completely switch from smoking cigarettes to oral tobacco-derived nicotine (OTDN) products compared to those who continue exclusive smoking cigarettes or stop using all tobacco products.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTobacco Use
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20192020202120222023202420252026
Enrollment StartMay 2018
Primary CompletionOct 2018
First PostedOct 2018
TodayJul 2026
First PostedOct 2, 2018
Enrollment StartMay 30, 2018
Primary CompletionOct 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 7.8 years ago
Interventions
OTDN product 1other
Oral tobacco-derived nicotine product
OTDN product 2other
Oral tobacco-derived nicotine product
Tobacco Cessationother
Tobacco Cessation