NCT06568900

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 31, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2024

Completed
Last Updated

August 23, 2024

Status Verified

August 1, 2024

Enrollment Period

1.1 years

First QC Date

August 21, 2024

Last Update Submit

August 21, 2024

Conditions

Tobacco Use

Keywords

nicotinetobacconicotine containing products

Outcome Measures

Primary Outcomes (1)

  • 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).

    Measured from baseline to week 12

Study Arms (3)

(control) continue smoking their usual brand of CC

ACTIVE COMPARATOR
Other: cigarette smoking

tobacco flavor and unflavored options of ZYN

ACTIVE COMPARATOR
Other: tobacco flavored and unflavored pouch

unrestricted flavor options of ZYN

ACTIVE COMPARATOR
Other: unrestricted flavor options pouch

Interventions

cigarette smokingOTHER

continue smoking usual brand of cigarette

(control) continue smoking their usual brand of CC
tobacco flavored and unflavored pouchOTHER

provide tobacco flavored and unflavored options of nicotine pouch

tobacco flavor and unflavored options of ZYN
unrestricted flavor options pouchOTHER

provide unrestricted flavor options of nicotine pouch

unrestricted flavor options of ZYN

Eligibility Criteria

Age22 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rose Research Center

Raleigh, North Carolina, 27617, United States

Location

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Brian E Erkkila, PhD

    Swedish Match

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2024

First Posted

August 23, 2024

Study Start

July 31, 2023

Primary Completion

August 19, 2024

Study Completion

August 19, 2024

Last Updated

August 23, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)