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

Not Applicable

Completed

• Conditions: Tobacco Use
• Interventions: Other: unrestricted flavor options pouch; Other: cigarette smoking; Other: tobacco flavored and unflavored pouch

• Registration Number: NCT06568900
• Lead Sponsor: Swedish Match AB

Brief 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.

Study Timeline

• Study Start: 2023-07-31
• Status Verified: 2024-08
• Primary Completion: 2024-08-19
• Study Completion: 2024-08-19
• Study First Submitted: 2024-08-21
• Study First Submitted QC: 2024-08-21
• Last Update Submitted: 2024-08-21
• Study First Posted: 2024-08-23
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Healthy adult smokers 22 to 65 years of age (inclusive) at screening.
• Smokes an average of at least 10 commercially available cigarettes per day for the last 12 months.
• Interested in switching from combustible cigarettes to nicotine pouch products.

Exclusion Criteria

• Participants of childbearing potential (CBP) who are breast-feeding or have a positive pregnancy test.
• Participants who currently use nicotine pouches.
• Participants with known heart disease or medical condition that may adversely affect participant safety

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
unrestricted flavor options of ZYN	unrestricted flavor options pouch	-
(control) continue smoking their usual brand of CC	cigarette smoking	-
tobacco flavor and unflavored options of ZYN	tobacco flavored and unflavored pouch	-

Primary Outcome Measures

Name	Time	Method
Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (total NNAL) in urine	Measured from baseline to week 12	Concentrations of total NNAL measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat).

Trial Locations

Locations (1)

Rose Research Center; 🇺🇸 Raleigh, North Carolina, United States