NCT04250727

Switching to Potential Reduced Exposure Products in Adult Smokers

Switching to a Non-tobacco-based Oral Nicotine Product Among Adult Cigarette Smokers: Exploring the Roles of Product Characteristics and User History

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 21 Years – 77 Years
• Healthy volunteers: Not accepted

Summary

This study aims to assess the feasibility, acceptability, and the potential harm reduction of switching to potentially lower risk, oral nicotine pouches in adult smokers. Part One of this study aims to assess the interest of current smokers in switching to an e-cigarette device (i.e. JUUL) compared to alternative non-combustible tobacco products (i.e. smokeless tobacco/snus) and/or medicinal nicotine via survey. Part Two will consist of a pilot study of 30 non-treatment seeking adult smokers to investigate within-person changes in smoking behavior as a result of switching to different concentrations of oral nicotine pouch products (i.e. ZYN, 3mg and 6mg nicotine concentration). Additionally, by measuring bio-markers of tobacco exposure from baseline, this will allow the study to assess the potential for harm reduction in switching from cigarettes to oral nicotine pouches.

Conditions

• Tobacco Use Disorder
• Oral Nicotine Pouch Use
• Smoking Behaviors
• Harm Reduction
• Toxic Effect of Tobacco and Nicotine
• Carcinogenesis

Interventions

Type	Name	Description
DEVICE	ZYN	30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.

Timeline

• Start date: 2021-05-01
• Primary completion: 2022-08-17
• Completion: 2022-08-17
• First posted: 2020-01-31
• Last updated: 2024-05-01
• Results posted: 2024-03-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study