Modeling Tobacco Regulatory Impacts in Appalachia Using the Experimental Tobacco Marketplace

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Mikhail N Koffarnus
Study ID
NCT06234722
Status
Enrolling By Invitation

Conditions

  • Cigarette Use
  • Tobacco Use

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Very Low Nicotine Cigarette — DRUG
    Participants will be assigned to one of two investigational cigarette nicotine levels for the duration of the experiment: 0.4mg/g or 15.8mg/g
  • Reduced nicotine regulatory environment — BEHAVIORAL
    In this regulatory environment, participants' usual combustible cigarette will not be available in the Experimental Tobacco Marketplace and only the participants' assigned investigational cigarette will be the only available combustible cigarette.
  • Restriction on characterizing flavors in combustible nicotine products — BEHAVIORAL
    In this regulatory environment, menthol and other characterizing flavors in combustible nicotine products will not be available in the Experimental Tobacco Marketplace. Only tobacco or no flavored combustible nicotine products will be the only combustible nicotine products available.
  • Restriction on characterizing flavors in noncombustible nicotine products — BEHAVIORAL
    In this regulatory environment, menthol and other characterizing flavors in noncombustible nicotine products will not be available in the Experimental Tobacco Marketplace. Only tobacco or no flavored noncombustible nicotine products will be the only noncombustible nicotine products available.

Study Details

The goal of this project is to look at the effect of proposed tobacco product regulations in Appalachian Kentucky. Appalachian Kentucky is a diverse and underserved rural area that would benefit from more tobacco regulation research. Researchers will study the effects of three proposed tobacco product regulations among users of tobacco products in Appalachian KY. Researchers will also study how degree of rurality effects how those regulations impact behavior. Participants will be asked to complete online surveys and tests, online shopping sessions in a simulated Experimental Tobacco Marketplace, and track their tobacco product use throughout the 9-week experiment.

Key Dates

Start date
Aug 16, 2024
Status verified
Aug 2024
Primary completion
Feb 29, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
473 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Placebo Comparator: Rural - Conventional Cigarette
    Participants who reside in rural locales of Appalachian KY and receive conventional cigarettes during the sampling period.
  • Placebo Comparator: Peri-Urban - Conventional Cigarette
    Participants who reside in peri-urban locales of Appalachian KY and receive conventional cigarettes during the sampling period.
  • Active Comparator: Peri-Urban - Very Low Nicotine Cigarette
    Participants who reside in peri-urban locales of Appalachian KY and receive very low nicotine cigarettes during the sampling period.
  • Active Comparator: Rural - Very Low Nicotine Cigarette
    Participants who reside in rural locales of Appalachian KY and receive very low nicotine cigarettes during the sampling period.

Primary Outcome Measure

Aggregate behavioral economic demand across all participants under the proposed regulatory environments [ Time Frame: Assessed at study week 0 and at study week 9 ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40504-

Find similar trials in Lexington, KY

By research site
University of Kentucky· Lexington, KY

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