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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06568900

Enrollment

450

Registered

2024-08-23

Start date

2023-07-31

Completion date

2024-08-19

Last updated

2024-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Use

Keywords

nicotine, tobacco, nicotine containing products

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.

Interventions

OTHERcigarette smoking

continue smoking usual brand of cigarette

OTHERtobacco flavored and unflavored pouch

provide tobacco flavored and unflavored options of nicotine pouch

OTHERunrestricted flavor options pouch

provide unrestricted flavor options of nicotine pouch

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

22 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026