NCT07458607

Brief Summary

The main purpose of this trial is to evaluate the impact of a menthol cigarette ban accompanied by a quit smoking campaign on tobacco purchasing behavior. Investigators will conduct a randomized clinical trial with \~1,185 US adults (ages 21+ years) who currently smoke menthol cigarettes.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,185

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Apr 2026

Typical duration for not_applicable

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 Progress5%
Apr 2026Apr 2028

First Submitted

Initial submission to the registry

March 4, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 20, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

April 27, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

March 4, 2026

Last Update Submit

April 23, 2026

Conditions

Health Behavior

Outcome Measures

Primary Outcomes (1)

  • Purchasing any combustible tobacco products

    Measured using purchase data for combustible tobacco products, defined as any cigarettes or little cigars and cigarillos. Response options are "No" (coded as 0) and "Yes" (coded as 1).

    Assessed 2 times approximately 1-week apart, starting on the day of enrollment.

Secondary Outcomes (11)

  • Expenditures on combustible tobacco products

    Assessed 2 times approximately 1-week apart, starting on the day of enrollment.

  • Purchasing any non-combustible tobacco products (substitution effects)

    Assessed 2 times approximately 1-week apart, starting on the day of enrollment.

  • Attempted to quit smoking

    Assessed 1 time, approximately 1 week after enrollment.

  • Forgoing cigarette use

    Assessed 1 time, approximately 1 week after enrollment.

  • Intentions to quit smoking

    Assessed 2 times approximately 1-week apart, starting on the day of enrollment.

  • +6 more secondary outcomes

Study Arms (3)

Menthol ban + campaign

EXPERIMENTAL
Behavioral: Menthol ban + campaign

Menthol ban

EXPERIMENTAL
Behavioral: Menthol ban

Control

OTHER
Behavioral: Control

Interventions

Menthol ban + campaignBEHAVIORAL

Menthol cigarettes and flavored little cigars and cigarillos will not be available for purchase in the store. Participants will receive quit smoking campaign ads via text message. These ads will also be displayed inside the store during the shopping tasks.

Menthol ban + campaign
ControlBEHAVIORAL

Menthol cigarettes and flavored little cigars and cigarillos will be available for purchase in the store. Participants will receive control ads about a neutral topic (i.e., password security) via text message. These ads will also be displayed inside the store during the shopping tasks.

Control
Menthol banBEHAVIORAL

Menthol cigarettes and flavored little cigars and cigarillos will not be available for purchase in the store. Participants will receive control ads about a neutral topic (i.e., password security) via text message. These ads will also be displayed inside the store during the shopping tasks.

Menthol ban

Eligibility Criteria

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

You may qualify if:

  • Are ages 21 years and older
  • Smoke cigarettes currently (i.e. currently smoke some days or every day and have smoked at least 100 cigarettes in their lifetime)
  • Smoke menthol cigarettes
  • Purchased menthol cigarettes in a store in the past month
  • Read and speak English
  • Can complete a survey on a computer without help
  • Can receive images by text message
  • Can attend 2 in-person appointments involving shopping tasks and computer surveys

You may not qualify if:

  • Are pregnant
  • Are breastfeeding
  • Enrolled currently in another research study about quitting smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Mini Mart

Raleigh, North Carolina, 27609, United States

RECRUITING

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Marissa G. Hall, PhD

    University of North Carolina, Chapel Hill

    STUDY DIRECTOR

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

March 4, 2026

First Posted

March 9, 2026

Study Start

April 20, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

April 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)