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Modeling Tobacco Regulatory Impacts in Appalachia Using the Experimental Tobacco Marketplace

M

Mikhail N Koffarnus

Status

Invitation-only

Conditions

Cigarette Use
Tobacco Use

Treatments

Behavioral: Restriction on characterizing flavors in combustible nicotine products
Behavioral: Reduced nicotine regulatory environment
Behavioral: Restriction on characterizing flavors in noncombustible nicotine products
Drug: Very Low Nicotine Cigarette

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06234722
87440
1U54DA058256-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

After granting informed consent, participants will complete a baseline assessment session. This will be followed by an extended 9-week sampling period to acclimate participants to their randomly assigned experimental cigarette and allow any shifts in product consumption patterns to materialize. In the final week of this sampling period, participants will complete behavioral assessments and a series of assessments to assess the impact of potential regulatory environments relevant to our aims.

Experimental Tobacco Marketplace. In this procedure, participants will complete purchasing scenarios in our realistic tobacco/nicotine product marketplace to model and examine the impact of each of the proposed tobacco product regulations. Participants will be seated in front of a computer to access an online marketplace with an interface similar to many online merchants. This will allow participants to browse through the selection of products and add as many as they desire of each product to the virtual shopping cart. Each product will have the price clearly displayed along with an image and description of the product. The selection of products will vary based on the particular regulatory scenario that is being modeled. Tobacco and nicotine products will match the products found by surveying product availability vendors in the local communities. In each pricing scenario during each marketplace session, participants will be asked to make nicotine-product purchases sufficient for one week's use from this marketplace. During a purchasing session, the participant will be provided with a virtual budget that matches their actual weekly budget for nicotine/tobacco products, a procedure we have shown to generate realistic results. They will use that virtual budget to indicate which selection of products they would purchase from those available in the marketplace.

Baseline Assessment Session. The first experimental session will be an assessment session to collect information from participants on substance use patterns and addiction severity, as well as the results of behavioral and cognitive tasks that have measure components of our behavioral economic model of product valuation.

Sampling Period. After their assessment session, participants will be given a supply of their randomly assigned reduced-nicotine cigarette corresponding to two weeks of their typical cigarette consumption and asked to use the provided cigarettes as their only combusted tobacco product for 9 consecutive weeks.

Enrollment

473 estimated patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • At least 21 years old
  • Consume nicotine and/or tobacco products daily
  • Have no plans to quit nicotine/tobacco consumption or seek treatment in the subsequent 9 weeks
  • Read and understand English

Exclusion Criteria:

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

473 participants in 4 patient groups, including a placebo group

Rural - Conventional Cigarette
Placebo Comparator group
Description:
Participants who reside in rural locales of Appalachian KY and receive conventional cigarettes during the sampling period.
Treatment:
Behavioral: Restriction on characterizing flavors in noncombustible nicotine products
Behavioral: Restriction on characterizing flavors in combustible nicotine products
Behavioral: Reduced nicotine regulatory environment
Peri-Urban - Conventional Cigarette
Placebo Comparator group
Description:
Participants who reside in peri-urban locales of Appalachian KY and receive conventional cigarettes during the sampling period.
Treatment:
Behavioral: Restriction on characterizing flavors in noncombustible nicotine products
Behavioral: Restriction on characterizing flavors in combustible nicotine products
Behavioral: Reduced nicotine regulatory environment
Peri-Urban - Very Low Nicotine Cigarette
Active Comparator group
Description:
Participants who reside in peri-urban locales of Appalachian KY and receive very low nicotine cigarettes during the sampling period.
Treatment:
Drug: Very Low Nicotine Cigarette
Behavioral: Restriction on characterizing flavors in noncombustible nicotine products
Behavioral: Restriction on characterizing flavors in combustible nicotine products
Behavioral: Reduced nicotine regulatory environment
Rural - Very Low Nicotine Cigarette
Active Comparator group
Description:
Participants who reside in rural locales of Appalachian KY and receive very low nicotine cigarettes during the sampling period.
Treatment:
Drug: Very Low Nicotine Cigarette
Behavioral: Restriction on characterizing flavors in noncombustible nicotine products
Behavioral: Restriction on characterizing flavors in combustible nicotine products
Behavioral: Reduced nicotine regulatory environment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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