NCT07102082

Brief Summary

To explore consumer responses to the announcement and implementation of new modified risk claims for Copenhagen and General Snus (brands of smokeless tobacco (ST) products) using a series of complementary and innovative research activities and methods.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress52%
Sep 2025Nov 2026

First Submitted

Initial submission to the registry

July 28, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 3, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

September 25, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

December 4, 2025

Status Verified

November 1, 2025

Enrollment Period

1.2 years

First QC Date

July 28, 2025

Last Update Submit

November 26, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Demand for cigarettes

    After watching a series of advertisements for oral smokeless tobacco products, participants will provide opinions of them, including likelihood of buying product.

    After one session - 1 hour

  • Increase in knowlege of tobacco-associated diseases

    multi item assessment questionnaires of perceived harm/risks from products

    After one session - I hour

Study Arms (2)

Group A - no claim

SHAM COMPARATOR

Participants view smokeless tobacco ads with no claims

Behavioral: Modified Risk - None

Group B - Modified Risk Tobacco Product Claim

ACTIVE COMPARATOR

Participants view ads with a modified risk claim

Behavioral: Modified Risk Claim

Interventions

Participants view ads with no modified risk claim

Group A - no claim

Participants view ads with a modified risk claim

Group B - Modified Risk Tobacco Product Claim

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Residing in one of the 8 counties of Western New York (Erie, Niagara, Cattaraugus, Chautauqua, Allegheny, Livingston, Genesee, Orleans, Wyoming).
  • Smoke cigarettes every day, at least 5 cigarettes per day, for at least 1 year.
  • Open to trying a non-combusted oral tobacco product.
  • Have access to a device (ie: computer/tablet/smartphone) with internet capabilities to participate in an online survey study.
  • Have the ability to read, write, and communicate in English.
  • Participant must understand the investigational nature of this study and an Independent Ethics Committee/Institutional Review Board approved information sheet prior to receiving any study related procedure

You may not qualify if:

  • Plan to quit smoking in the next 30 days.
  • Use of smokeless tobacco at least weekly in the last 6 months.
  • Lifetime use (that is, ever used at any time prior to the study) of Copenhagen or General Snus.
  • Unwilling or unable to follow protocol requirements.
  • Pregnant or planning to become pregnant (by self report)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roswell Park

Buffalo, New York, 14206, United States

RECRUITING

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Richard O'Connor

    Roswell Park

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2025

First Posted

August 3, 2025

Study Start

September 25, 2025

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

December 4, 2025

Record last verified: 2025-11

Locations