CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 149 enrolled
Drug / intervention
OTDN Product 1 +3 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/NCT05664672
NCT05664672N/ACompleted
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A Randomized, Controlled, Open-label Short-term Study to Evaluate Changes in Exposure to Harmful and Potentially Harmful Constituents in Adult Smokers Who Completely Switch to on!® Nicotine Pouches in a Clinical Setting

Altria Client Services LLC·interventional·Posted Dec 27, 2022·Updated Dec 9, 2024

In Brief

A clinical study evaluating OTDN Product 1, OTDN Product 2, and 2 other interventions for Tobacco Use. Completed, enrolled 149 participants across 3 sites.

Detailed Summary

The purpose of this study is to generate evidence regarding the extent of reduction in exposure to selected HPHCs in adult smokers switching to on!® NPs. The study intends to determine changes in exposure to selected HPHCs by measuring biomarkers in adult smokers who completely switch from smoking to use of on!® NP compared to those who continue smoking cigarettes or stop using all tobacco products.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTobacco Use
CountriesUnited States
CollaboratorsCovance

Timeline

N/ACompletedFinished
20222023202420252026
First PostedDec 27, 2022
Enrollment StartMay 11, 2021
Primary CompletionAug 31, 2021
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 3.5 years ago

Interventions

OTDN Product 1other

Mint on!® 2 mg nicotine pouches

OTDN Product 2other

Mint on!® 4 mg nicotine pouches

OTDN Product 3other

Mint on!® 8 mg nicotine pouches

No Tobaccoother

subjects completely stop all tobacco product usage for 7 days