NCT06568900

Randomized Controlled Trial to Evaluate the Impact of ZYN Nicotine Pouch Products on Cigarette Usage and BoExp in Adult Smokers Over a 12-week Period

A Randomized Controlled Trial to Evaluate the Impact of ZYN Nicotine Pouch Products on Cigarette Usage and Biomarkers of Exposure in Adult Smokers Over a 12-week Period

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (actual)
• Sponsor: Swedish Match AB · Industry
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Accepted

Summary

To verify whether unrestricted access to flavored products is likely to lead to greater reductions in combustible cigarette smoking and decreased exposure to smoking related toxicants.

Detailed description

US adult smokers will be randomized into three groups (Group I: (control) continue smoking their usual brand of CC; Group II: provided with tobacco flavor and unflavored options of ZYN; Group III: provide with unrestricted flavor options of ZYN) to evaluate the impact of availability of different ZYN products on cigarette usage patterns and biomarkers of exposure over a 12-week study period, followed by an 6-week extension for some participants.

Conditions

• Tobacco Use

Interventions

Type	Name	Description
OTHER	cigarette smoking	continue smoking usual brand of cigarette
OTHER	tobacco flavored and unflavored pouch	provide tobacco flavored and unflavored options of nicotine pouch
OTHER	unrestricted flavor options pouch	provide unrestricted flavor options of nicotine pouch

Timeline

• Start date: 2023-07-31
• Primary completion: 2024-08-19
• Completion: 2024-08-19
• First posted: 2024-08-23
• Last updated: 2024-08-23

Locations

1 site across 1 country: United States