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