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Completed

NCT Number: NCT06568900

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

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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Key information

Conditions

Tobacco Use Behavior

Age range

22 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rose Research Center

Raleigh, North Carolina, 27617, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cigarette smoking

Other

continue smoking usual brand of cigarette

tobacco flavored and unflavored pouch

Other

provide tobacco flavored and unflavored options of nicotine pouch

unrestricted flavor options pouch

Other

provide unrestricted flavor options of nicotine pouch

Primary outcomes

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

    Time frame: Measured from baseline to week 12

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

Sponsors and collaborators

Lead sponsor

Swedish Match AB

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 23, 2024
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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