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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-31

Study Completion Date

2024-08-19

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tobacco Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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(control) continue smoking their usual brand of CC

Group Type ACTIVE_COMPARATOR

cigarette smoking

Intervention Type OTHER

continue smoking usual brand of cigarette

tobacco flavor and unflavored options of ZYN

Group Type ACTIVE_COMPARATOR

tobacco flavored and unflavored pouch

Intervention Type OTHER

provide tobacco flavored and unflavored options of nicotine pouch

unrestricted flavor options of ZYN

Group Type ACTIVE_COMPARATOR

unrestricted flavor options pouch

Intervention Type OTHER

provide unrestricted flavor options of nicotine pouch

Interventions

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cigarette smoking

continue smoking usual brand of cigarette

Intervention Type OTHER

tobacco flavored and unflavored pouch

provide tobacco flavored and unflavored options of nicotine pouch

Intervention Type OTHER

unrestricted flavor options pouch

provide unrestricted flavor options of nicotine pouch

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

22 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes