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

August 21, 2024 updated by: Swedish Match AB

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Raleigh, North Carolina, United States, 27617
        • Rose Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: (control) continue smoking their usual brand of CC
Other: cigarette smoking
continue smoking usual brand of cigarette
Active Comparator: tobacco flavor and unflavored options of ZYN
Other: tobacco flavored and unflavored pouch
provide tobacco flavored and unflavored options of nicotine pouch
Active Comparator: unrestricted flavor options of ZYN
Other: unrestricted flavor options pouch
provide unrestricted flavor options of nicotine pouch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Measured from baseline to week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swedish Match AB

Investigators

  • Study Chair: Brian E Erkkila, PhD, Swedish Match

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2023

Primary Completion (Actual)

August 19, 2024

Study Completion (Actual)

August 19, 2024

Study Registration Dates

First Submitted

August 21, 2024

First Submitted That Met QC Criteria

August 21, 2024

First Posted (Actual)

August 23, 2024

Study Record Updates

Last Update Posted (Actual)

August 23, 2024

Last Update Submitted That Met QC Criteria

August 21, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00070188

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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