Modeling Tobacco Regulatory Impacts in Appalachia Using the Experimental Tobacco Marketplace

August 16, 2024 updated by: Mikhail N Koffarnus
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

473

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • University of Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Rural - Conventional Cigarette
Participants who reside in rural locales of Appalachian KY and receive conventional cigarettes during the sampling period.
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.
Behavioral: 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.
Behavioral: 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.
Placebo Comparator: Peri-Urban - Conventional Cigarette
Participants who reside in peri-urban locales of Appalachian KY and receive conventional cigarettes during the sampling period.
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.
Behavioral: 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.
Behavioral: 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.
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.
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.
Behavioral: 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.
Behavioral: 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.
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
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.
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.
Behavioral: 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.
Behavioral: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aggregate behavioral economic demand across all participants under the proposed regulatory environments
Time Frame: Assessed at study week 0 and at study week 9
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
Aggregate behavioral economic substitution across all participants under the proposed regulatory environments
Time Frame: Assessed at study week 0 and at study week 9
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delay Discounting Tasks
Time Frame: Assessed at study week 0 and at study week 9
Assesses valuation for future money and nicotine products.
Assessed at study week 0 and at study week 9
Breath Carbon Monoxide (CO)
Time Frame: Collected twice daily through the 10 week duration of the study
Breath carbon monoxide readings collected using our app
Collected twice daily through the 10 week duration of the study
Salivary Cotinine
Time Frame: Collected with assessment sessions at study weeks 0 and 9, as well as twice weekly remotely during interim sampling period
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
Self-reported nicotine product use
Time Frame: Collected daily from study week 1 to study week 9
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
Timeline Follow-Back (TLFB): Average of marijuana and nicotine use quantity
Time Frame: Assessed at study week 0 and at study week 9
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
Fagerström Test for Nicotine Dependence (FTND)
Time Frame: Assessed at study week 0 and at study week 9
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
Minnesota Nicotine Withdrawal Scale (MNWS)
Time Frame: Assessed at study week 0 and at study week 9
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
Hypothetical quantity purchased in purchase tasks
Time Frame: Assessed at study week 0 and at study week 9
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
Activity Level Questionnaire - Substance Use Version (ALQ-SUV)
Time Frame: Assessed at study week 0 and at study week 9
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
Self-reported withdrawal symptom severity
Time Frame: Collected daily from study week 1 to study week 9
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
Self-reported nicotine craving intensity
Time Frame: Collected daily from study week 1 to study week 9
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mikhail N Koffarnus

Collaborators

National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2024

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Actual)

August 19, 2024

Last Update Submitted That Met QC Criteria

August 16, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

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

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only deidentified data will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tobacco Use

Clinical Trials on Reduced nicotine regulatory environment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe