Modeling Tobacco Regulatory Impacts in Appalachia Using the Experimental Tobacco Marketplace

NCT06234722 | Enrolling By Invitation DMC

• 2 other identifiers: 874401U54DA058256-01
• Study Type: interventional
• Target: 473
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use; Cigarette Use

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (11)

• Timeline Follow-Back (TLFB): Average of marijuana and nicotine use quantity

  Assessed at study week 0 and at study week 9

• Fagerström Test for Nicotine Dependence (FTND)

  Assessed at study week 0 and at study week 9

• Minnesota Nicotine Withdrawal Scale (MNWS)

  Assessed at study week 0 and at study week 9

• Hypothetical quantity purchased in purchase tasks

  Assessed at study week 0 and at study week 9

• Delay Discounting Tasks

  Assessed at study week 0 and at study week 9

Study Arms (4)

Rural - Conventional Cigarette

PLACEBO COMPARATOR

Participants who reside in rural locales of Appalachian KY and receive conventional cigarettes during the sampling period.

Behavioral: Reduced nicotine regulatory environment; Behavioral: Restriction on characterizing flavors in combustible nicotine products; Behavioral: Restriction on characterizing flavors in noncombustible nicotine products

Peri-Urban - Conventional Cigarette

PLACEBO COMPARATOR

Participants who reside in peri-urban locales of Appalachian KY and receive conventional cigarettes during the sampling period.

Behavioral: Reduced nicotine regulatory environment; Behavioral: Restriction on characterizing flavors in combustible nicotine products; Behavioral: Restriction on characterizing flavors in noncombustible nicotine products

Peri-Urban - Very Low Nicotine Cigarette

ACTIVE COMPARATOR

Participants who reside in peri-urban locales of Appalachian KY and receive very low nicotine cigarettes during the sampling period.

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

Rural - Very Low Nicotine Cigarette

ACTIVE COMPARATOR

Participants who reside in rural locales of Appalachian KY and receive very low nicotine cigarettes during the sampling period.

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

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

Peri-Urban - Very Low Nicotine Cigarette; Rural - Very Low Nicotine Cigarette

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.

Peri-Urban - Conventional Cigarette; Peri-Urban - Very Low Nicotine Cigarette; Rural - Conventional Cigarette; Rural - Very Low Nicotine 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.

Peri-Urban - Conventional Cigarette; Peri-Urban - Very Low Nicotine Cigarette; Rural - Conventional Cigarette; Rural - Very Low Nicotine Cigarette

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.

Peri-Urban - Conventional Cigarette; Peri-Urban - Very Low Nicotine Cigarette; Rural - Conventional Cigarette; Rural - Very Low Nicotine Cigarette

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Mikhail N Koffarnus: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40504, United States

Location

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Mixed crossover-factorial

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 31, 2024
• Study Start: August 16, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)