Clinical trial NCT06234722: Modeling Tobacco Regulatory Impacts in Appalachia Using the Experimental Tobacco Marketplace
Official title: Modeling Tobacco Regulatory Impacts in Appalachia Using the Experimental Tobacco Marketplace
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Tobacco Use
Cigarette Use
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-01-31
Enrollment: 473
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Mixed crossover-factorial
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility 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:

Primary outcomes:
measure: Aggregate behavioral economic demand across all participants under the proposed regulatory environments
timeFrame: Assessed at study week 0 and at study week 9
measure: Aggregate behavioral economic substitution across all participants under the proposed regulatory environments
timeFrame: Assessed at study week 0 and at study week 9
Secondary outcomes:
measure: Timeline Follow-Back (TLFB): Average of marijuana and nicotine use quantity
timeFrame: Assessed at study week 0 and at study week 9
measure: Fagerström Test for Nicotine Dependence (FTND)
timeFrame: Assessed at study week 0 and at study week 9
measure: Minnesota Nicotine Withdrawal Scale (MNWS)
timeFrame: Assessed at study week 0 and at study week 9
measure: Hypothetical quantity purchased in purchase tasks
timeFrame: Assessed at study week 0 and at study week 9
measure: Delay Discounting Tasks
timeFrame: Assessed at study week 0 and at study week 9
measure: Activity Level Questionnaire - Substance Use Version (ALQ-SUV)
timeFrame: Assessed at study week 0 and at study week 9
measure: Breath Carbon Monoxide (CO)
timeFrame: Collected twice daily through the 10 week duration of the study
measure: Salivary Cotinine
timeFrame: Collected with assessment sessions at study weeks 0 and 9, as well as twice weekly remotely during interim sampling period
measure: Self-reported nicotine product use
timeFrame: Collected daily from study week 1 to study week 9
measure: Self-reported withdrawal symptom severity
timeFrame: Collected daily from study week 1 to study week 9
measure: Self-reported nicotine craving intensity
timeFrame: Collected daily from study week 1 to study week 9
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
References: