Modeling Tobacco Regulatory Impacts in Appalachia Using the Experimental Tobacco Marketplace

Tobacco Use Clinical Trial

Official title:

Modeling Tobacco Regulatory Impacts in Appalachia Using the Experimental Tobacco Marketplace

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06234722
• Other study ID #: 87440
• Secondary ID: 1U54DA058256-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: August 2028

Study information

• Verified date: April 2024
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 473
• Est. completion date: August 2028
• Est. primary completion date: February 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Tobacco Use

Intervention

Drug:
• Very Low Nicotine Cigarette
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

Behavioral:
• Reduced nicotine regulatory environment
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
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
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Mikhail N Koffarnus	National Institute on Drug Abuse (NIDA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aggregate behavioral economic demand across all participants under the proposed regulatory environments	Participants will complete trials of the Experimental Tobacco Marketplace wherein the price of a target commodity will be increased. Nonlinear mixed effects modeling will be used to fit a curve to estimate the number of products purchased at each price and the analysis will result in an measure of overall price sensitivity under each of the regulatory conditions.	Assessed at study week 0 and at study week 9
Primary	Aggregate behavioral economic substitution across all participants under the proposed regulatory environments	Participants will complete trials of the Experimental Tobacco Marketplace wherein the price of alternative products will be fixed across trials and their usual product will change price. Mixed effects modeling will be used to fit a curve to estimate the slopes and intercepts of these alternative products, revealing the degree to which participants will choose to purchase each alternative product as the price of the participant's usual product increases.	Assessed at study week 0 and at study week 9
Secondary	Timeline Follow-Back (TLFB): Average of marijuana and nicotine use quantity	Self-reported marijuana and nicotine product use separated by product type and flavor for the past 60 days.	Assessed at study week 0 and at study week 9
Secondary	Fagerström Test for Nicotine Dependence (FTND)	Measure of dependence symptoms, measured on a scale of 0 to 10. A higher score indicates a higher physical dependence on nicotine.	Assessed at study week 0 and at study week 9
Secondary	Minnesota Nicotine Withdrawal Scale (MNWS)	Assesses Withdrawal Symptoms. Scored on an ordinal scale ranging from 0 to 3. A higher score indicates increased intensity of symptoms.	Assessed at study week 0 and at study week 9
Secondary	Hypothetical quantity purchased in purchase tasks	Measures valuation by assessing hypothetical consumption across a price range and across the range of products used by participants in the past 60 days.	Assessed at study week 0 and at study week 9
Secondary	Delay Discounting Tasks	Assesses valuation for future money and nicotine products.	Assessed at study week 0 and at study week 9
Secondary	Activity Level Questionnaire - Substance Use Version (ALQ-SUV)	Measures past-month reinforcement from substance-related and substance-free activities, yielding a reinforcement ratio quantifying the proportion of overall reinforcement obtained from nicotine use. The ratio ranges from 0 to 1, with a higher score indicating a greater proportion of reinforcement received from drug-related activities relative to total reinforcement.	Assessed at study week 0 and at study week 9
Secondary	Breath Carbon Monoxide (CO)	Breath carbon monoxide readings collected using our app	Collected twice daily through the 10 week duration of the study
Secondary	Salivary Cotinine	Salivary cotinine collected with rapid test, verified via smartphone app	Collected with assessment sessions at study weeks 0 and 9, as well as twice weekly remotely during interim sampling period
Secondary	Self-reported nicotine product use	The number of tobacco cigarettes, marijuana cigarettes, and other nicotine/tobacco products consumed. Will be collected with our app.	Collected daily from study week 1 to study week 9
Secondary	Self-reported withdrawal symptom severity	On a scale from 0 to 9, participants will report their withdrawal symptom severity in our smartphone app. A higher score indicates more severe symptoms.	Collected daily from study week 1 to study week 9
Secondary	Self-reported nicotine craving intensity	On a scale from 0 to 9, participants will report their nicotine craving intensity in our smartphone app. A higher score indicates more intense cravings.	Collected daily from study week 1 to study week 9