NCT03692078

A Study to Evaluate Changes in Smokers Using Oral Tobacco-derived Nicotine Products.

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 231 (actual)
• Sponsor: Altria Client Services LLC · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is an open label, randomized, 6 parallel-group clinical study evaluating changes in exposure to selected HPHCs, subjective effects, and product use behavior in adult smokers relative to continued smoking who are randomly assigned to continue smoking, partially or completely switch to oral tobacco-derived nicotine products, or stop using any tobacco products for 7 days.

Conditions

• Tobacco Use

Interventions

Type	Name	Description
OTHER	OTDN product 1	Oral tobacco-derived nicotine product
OTHER	OTDN product 2	Oral tobacco-derived nicotine product
OTHER	Tobacco Cessation	Tobacco Cessation

Timeline

• Start date: 2018-05-30
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2018-10-02
• Last updated: 2024-11-25
• Results posted: 2024-11-25

Locations

2 sites across 1 country: United States