Promotion and Mitigation Factors Leading to Illegal Tobacco Purchases

This study will investigate the effects of promotion factors and mitigation strategies on legal and illegal tobacco purchases for different tobacco-user types.

Study Overview

• Status: Completed
• Conditions: Cigarette Smoking; Nicotine Vaping
• Intervention / Treatment: Behavioral: Promotion factors; Behavioral: Mitigation strategies

Detailed Description

In the present study, we propose to examine some promotion factors and mitigation strategies and how they impact tobacco product legal and illegal purchases. Specifically, we have developed an Illegal Experimental Tobacco Marketplace (iETM). The iETM permits us to identify the number, type, and characteristics of tobacco users who would seek illegal tobacco products and the conditions that would induce them to seek that option. The critical questions we seek to answer are whether changes in product standards and availability will engender illegal tobacco purchasing as a function of tobacco user type (e.g., exclusive combustible product users, and dual cigarette/NVP users). Understanding the user types and the relevant conditions will inform greater tailoring of policy to diminish consumer interest in an illegal market.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24016
      • Fralin Biomedical Research Institute at VTC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Provide informed consent
• Be at least 21 years of age or older
• Provide a breath sample for measuring carbon monoxide (CO ≥ 8 ppm)
• Stable tobacco use patterns for at least two months

For exclusive cigarette smokers:

• Smoke at least 10 cigarettes daily and do not use NVPs regularly (no more than 9 times in the last month).
• For dual cigarette/NVP users:
• Smoke at least 10 cigarettes daily and use NVPs at least 3 times in a week (report use of closed nicotine salt system)

Exclusion criteria:

• Have plans to move out of the area
• Have a serious or unstable physical or mental health condition
• Taking a tobacco cessation medication or medication that interferes with nicotine metabolism, motivation or reinforcement
• Report concrete, immediate plans to alter/quit using their usual nicotine products at the beginning of the study
• Being pregnant or lactating

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Exclusive cigarette smokers; Exclusive cigarette smokers will be recruited and will be exposed to all of the conditions described in the intervention section.	Behavioral: Promotion factors; In the full nicotine conditions, participants' preferred cigarettes and NVP products will be available in the LETM and preferred cigarettes will be available in the iETM. In the low nicotine conditions, a ban will permit only VLNCs in the LETM and preferred cigarettes will be available in the iETM.; Behavioral: Mitigation strategies; Penalties: Penalties will be presented as a 60% chance of getting caught making illegal purchases. The consequences of illegal purchases include not receiving any study products from the ETM if they were caught and randomly drew that trial.
Experimental: Experimental: Dual cigarette/ nicotine vaping product users; Dual cigarette and nicotine vaping product users will be recruited and will be exposed to all of the conditions described in the intervention section	Behavioral: Promotion factors; In the full nicotine conditions, participants' preferred cigarettes and NVP products will be available in the LETM and preferred cigarettes will be available in the iETM. In the low nicotine conditions, a ban will permit only VLNCs in the LETM and preferred cigarettes will be available in the iETM.; Behavioral: Mitigation strategies; Penalties: Penalties will be presented as a 60% chance of getting caught making illegal purchases. The consequences of illegal purchases include not receiving any study products from the ETM if they were caught and randomly drew that trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Budget Spent on Illegal Cigarettes Across Policy Conditions	The study has 4 policy conditions with combinations of promotion strategy (VLNC standard) and mitigation strategy (penalties), and each combination: No Policy, Penalty only, VLNC only, and Penalty + VLNC. The average percentage of the budget spent on illegal cigarettes across all trials was calculated for each policy scenario.	1 day
Percent Budget Spent on Legal Cigarettes Across Policy Conditions	The study has 4 policy conditions with combinations of promotion strategy (VLNC standard) and mitigation strategy (penalties), and each combination: No Policy, Penalty only, VLNC only, and Penalty + VLNC. The average percentage of the budget spent on legal cigarettes across all trials was calculated for each policy scenario.	1 day
Percent Budget Spent on E-cigarettes Across Policy Conditions	The study has 4 policy conditions with combinations of promotion strategy (VLNC standard) and mitigation strategy (penalties), and each combination: No Policy, Penalty only, VLNC only, and Penalty + VLNC. The average percentage of the budget spent on e-cigarettes across all trials was calculated for each policy scenario.	1 day
Percent Budget Spent on Nicotine Replacement Therapy Across Policy Conditions	The study has 4 policy conditions with combinations of promotion strategy (VLNC standard) and mitigation strategy (penalties), and each combination: No Policy, Penalty only, VLNC only, and Penalty + VLNC. The average percentage of the budget spent on nicotine replacement theray across all trials was calculated for each policy scenario.	1 day
Percent Budget Spent on Oral Nicotine/Tobacco Across Policy Conditions	The study has 4 policy conditions with combinations of promotion strategy (VLNC standard) and mitigation strategy (penalties), and each combination: No Policy, Penalty only, VLNC only, and Penalty + VLNC. The average percentage of the budget spent on oral nicotine/tobacco across all trials was calculated for each policy scenario.	1 day

Collaborators and Investigators

• Sponsor: Virginia Polytechnic Institute and State University
• Collaborators: Medical University of South Carolina
• Investigators: Principal Investigator: Roberta Freitas-Lemos, Ph.D., Fralin Biomedical Research Institute at Virginia Tech Carilion

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2024
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): March 31, 2025

Study Registration Dates

• First Submitted: August 14, 2023
• First Submitted That Met QC Criteria: August 14, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Smoking; Tobacco Smoking; Tobacco Use; Vaping; Cigarette Smoking
• Other Study ID Numbers: 5P01CA200512 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study team will share de-identified data upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No