Promotion and Mitigation Factors Leading to Illegal Tobacco Purchases

NCT06001840 | Completed Results

• 1 other identifier: 5P01CA200512
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cigarette Smoking; Nicotine Vaping

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Experimental: Exclusive cigarette smokers

EXPERIMENTAL

Exclusive cigarette smokers will be recruited and will be exposed to all of the conditions described in the intervention section.

Behavioral: Promotion factors; Behavioral: Mitigation strategies

Experimental: Dual cigarette/ nicotine vaping product users

EXPERIMENTAL

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; Behavioral: Mitigation strategies

Interventions

Promotion factors BEHAVIORAL

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.

Experimental: Dual cigarette/ nicotine vaping product users; Experimental: Exclusive cigarette smokers

Mitigation strategies BEHAVIORAL

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: Dual cigarette/ nicotine vaping product users; Experimental: Exclusive cigarette smokers

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead
• Medical University of South Carolina: collaborator

Study Sites (1)

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Cigarette Smoking; Vaping

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Results Point of Contact

• Title: Dr. Roberta Freitas-Lemos
• Organization: Fralin Biomedical Research Institute at VTC

rflemos@vtc.vt.edu

540 526 2106

Study Officials

• Roberta Freitas-Lemos, Ph.D.

  Fralin Biomedical Research Institute at Virginia Tech Carilion

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: We will examine two promotion policies. 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 very-low nicotine cigarettes (VLNCs) in the LETM and preferred cigarettes will be available in the iETM. Additionally, we will model three mitigation strategies that may reduce iETM purchases: health communications, availability of nicotine replacement, and penalties. The three mitigation factors will be applied during both promotion policies described above.

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: January 4, 2024
• Primary Completion: February 28, 2025
• Study Completion: March 31, 2025
• Last Updated: February 10, 2026
• Results First Posted: February 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)