Effects of a Low Nicotine Standard and Tobacco Prices on Illegal Cigarette Purchasing

NCT07161050 | Recruiting

• 2 other identifiers: VT IRB #25-8135P01CA200512
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the effects of a very-low-nicotine cigarette (VLNC) standard, e-cigarette price, and illegal cigarette price on illegal product purchasing and alternative product use in a virtual marketplace.

Conditions

E-cigarette Use; Cigarette Smoking

Keywords

Experimental Tobacco Marketplace; Illegal cigarette

Outcome Measures

Primary Outcomes (1)

• Percent of budget allocated to each product category (eg, legal cigarettes, e-cigarettes, illegal cigarettes, etc) in the marketplace

  The investigators will measure the percent of each partcipants' study budget spent on products from each category (eg, legal cigarettes, e-cigarettes, illegal cigarettes, etc) in the marketplace

  1 day

Study Arms (2)

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: Nicotine Content; Behavioral: Illegal cigarette price; Behavioral: E-cigarette price

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: Nicotine Content; Behavioral: Illegal cigarette price; Behavioral: E-cigarette price

Interventions

Nicotine Content 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.

Also known as: very-low nicotine standard

Dual cigarette/ nicotine vaping product users; Exclusive cigarette smokers

Illegal cigarette price BEHAVIORAL

At each level of nicotine content, we will manipulate the price of illegal cigarettes (1xMP, 1.5x MP, 2x MP). MP is market price.

Dual cigarette/ nicotine vaping product users; Exclusive cigarette smokers

E-cigarette price BEHAVIORAL

At each level of nicotine content and illegal cigarette price, we will manipulate the price of e-cigarettes (1xMP, 1.5x MP, 2x MP). MP is the market price.

Dual cigarette/ nicotine vaping product users; 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

You may not qualify if:

• 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)
• For both groups:
• 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

• National Cancer Institute (NCI): collaborator
• Medical University of South Carolina: collaborator
• Virginia Polytechnic Institute and State University: lead

Study Sites (1)

Fralin Biomedical Research Institute at Virginia Tech Carilion

Roanoke, Virginia, 24016, United States

RECRUITING

MeSH Terms

Conditions

Cigarette Smoking; Vaping

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Study Officials

• Roberta Freitas-Lemos, PhD

  Fralin Biomedical Research Institute at Virginia Tech Carilion

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirstin Gatchalian

CONTACT

540-526-2071; kmgatch@vtc.vt.edu

Madeleine Mason, PhD

CONTACT

540-526-2114; mgmason@vtc.vt.edu

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: Assistant Professor

Model Details: Participants will complete one ETM session with a total of 18 purchasing trials, 9 trials in each of the two conditions - NNC and VLNC. The participant's preferred cigarette will be available in both the LETM and iETM in the NNC condition. In the VLNC condition, the preferred cigarette will be available only in the iETM and VLN cigarettes will be available in the LETM. E-cigarettes, nicotine replacement therapy, snus, and nicotine pouches will be available throughout all trials in the LETM. Within each condition, we will manipulate the price of illegal cigarettes (1xMP, 1.5x MP, 2x MP). At each level of illegal cigarette price, we will also manipulate the price of NVP (1/2x MP, 1x MP, 2x MP). This design will permit the investigation and comparison of the effects of a VLNC standard as well as changes in illegal and NVP price. The investigators will counterbalance the order of the conditions within the ETM session.

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 8, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 7, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)