NCT04079933

A Study to Evaluate Changes in Smokers Using An Oral Tobacco-Derived Nicotine Product

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Altria Client Services LLC · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

This was a randomized, controlled, open-label, parallel group, multicenter, 9-week study to determine changes in BOE in adult smokers allowed ad libitum use of an OTDN product relative to adult smokers who were not allowed to use an OTDN product. This study was conducted in adult smokers who were considered to be in overall good health. Subjects were randomized to Test (allowed OTDN use) or Control (not allowed OTDN use) groups.

Conditions

• Tobacco Use

Interventions

Type	Name	Description
OTHER	Oral tobacco-derived nicotine product (OTDN)

Timeline

• Start date: 2013-08-27
• Primary completion: 2013-11-26
• Completion: 2013-11-26
• First posted: 2019-09-06
• Last updated: 2024-09-27
• Results posted: 2024-09-27

Locations

3 sites across 1 country: United States