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Recruiting NCT07458607

UNC Tobacco Convenience Store

No phase Interventional Health Behavior

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Menthol ban + campaign, Menthol ban, Control.
Who it may be relevant to
Registry conditions: Health Behavior. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

UNC Tobacco Convenience Store Study

Overview

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.

Detailed description

This trial aims to determine whether a quit smoking campaign amplifies the impact of a simulated menthol cigarette ban. The trial will enroll \~1,185 adults ages 21 years and older who currently smoke menthol cigarettes. Participants will attend 2 in-person study visits at our experimental store, spaced approximately 1 week apart. The store will be stocked with a variety of tobacco products, food, non-alcoholic beverages, and household goods. At the first visit, participants will provide written informed consent and will be randomized to 1 of 3 trial arms, described further below. At both study visits, participants will shop for items in the store and complete computer surveys. Researchers will record in-store purchases and other self-reported measures will be assessed via the computer surveys. In between the in-person study visits, participants will receive ads via text message based on their trial arm.

Interventions

  • Behavioral Menthol ban + campaign
    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.
  • Behavioral Menthol ban
    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.
  • Behavioral Control
    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.

Primary outcome measures

  • Purchasing any combustible tobacco products [Time frame: Assessed 2 times approximately 1-week apart, starting on the day of enrollment.]
Secondary outcome measures (11)
  • Expenditures on combustible tobacco products [Time frame: Assessed 2 times approximately 1-week apart, starting on the day of enrollment.]
  • Purchasing any non-combustible tobacco products (substitution effects) [Time frame: Assessed 2 times approximately 1-week apart, starting on the day of enrollment.]
  • Attempted to quit smoking [Time frame: Assessed 1 time, approximately 1 week after enrollment.]
  • Forgoing cigarette use [Time frame: Assessed 1 time, approximately 1 week after enrollment.]
  • Intentions to quit smoking [Time frame: Assessed 2 times approximately 1-week apart, starting on the day of enrollment.]
  • Injunctive norms for quitting smoking [Time frame: Assessed 2 times approximately 1-week apart, starting on the day of enrollment.]
  • Targeted benefits of quitting smoking [Time frame: Assessed 2 times approximately 1-week apart, starting on the day of enrollment.]
  • Reactance towards cigarette options [Time frame: Assessed 2 times approximately 1-week apart, starting on the day of enrollment.]
  • Reactance towards ads [Time frame: Assessed 2 times approximately 1-week apart, starting on the day of enrollment.]
  • Stigma from cigarette options [Time frame: Assessed 2 times approximately 1-week apart, starting on the day of enrollment.]
  • Stigma from ads [Time frame: Assessed 2 times approximately 1-week apart, starting on the day of enrollment.]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • UNC Mini Mart — Raleigh

Identifiers

NCT: NCT07458607 · 24-0398 · U54DA060049

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗