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 AB450 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

450

Conditions

Tobacco Use

Interventions

cigarette smokingOTHER

continue smoking usual brand of cigarette

tobacco flavored and unflavored pouchOTHER

provide tobacco flavored and unflavored options of nicotine pouch

unrestricted flavor options pouchOTHER

provide unrestricted flavor options of nicotine pouch

Eligibility

Sex: ALLMin age: 22 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Rose Research Center

Raleigh, North Carolina, United States

Outcomes

Primary Outcomes

Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (total NNAL) in urine

Concentrations of total NNAL measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat).

Time frame: Measured from baseline to week 12

Data from ClinicalTrials.gov

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