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

Swedish Match AB

Status: Completed

Conditions: Tobacco Use

Treatments: Other: cigarette smoking; Other: tobacco flavored and unflavored pouch; Other: unrestricted flavor options pouch

Study type: Interventional

Funder types: Industry

Identifiers

NCT06568900

Pro00070188

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 patients

Sex: All

Ages: 22 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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450 participants in 3 patient groups

(control) continue smoking their usual brand of CC

Active Comparator group

Treatment:

Other: cigarette smoking

tobacco flavor and unflavored options of ZYN

Active Comparator group

Treatment:

Other: tobacco flavored and unflavored pouch

unrestricted flavor options of ZYN

Active Comparator group

Treatment:

Other: unrestricted flavor options pouch

Sponsor of this trial

Lead Sponsor

Swedish Match AB