How a very-low-nicotine cigarette standard and product prices affect illegal cigarette buying

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

This study will test whether requiring very-low-nicotine cigarettes and changing e-cigarette or illegal cigarette prices changes illegal cigarette buying and use of alternatives among adult smokers and dual users.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Virginia Polytechnic Institute and State University (Academic / other)
• Locations: 1 site (Roanoke, Virginia)
• Trial ID: NCT07161050 on ClinicalTrials.gov

What this trial studies

Researchers will bring adult exclusive cigarette smokers and dual cigarette/vaping users into a lab to complete an experimental virtual marketplace where legal and illegal product availability and prices are varied. Participants will complete three sessions (screening/assessment, the experimental tobacco marketplace session, and a follow-up phone call) and encounter scenarios comparing normal-nicotine and very-low-nicotine legal conditions. The experiment manipulates three levels of e-cigarette price and three levels of illegal cigarette price to see how those factors influence purchasing of illegal products and alternative nicotine product use. Outcomes will include choices made in the marketplace under each condition and differences by smoking/vaping status and age strata.

Who should consider this trial

Good fit: Adults aged 21 or older who smoke at least 10 cigarettes per day and are either exclusive smokers or regular dual users of cigarettes and nicotine vaping products, and who can attend three in-person sessions, are the intended participants.

Not a fit: People who are pregnant or lactating, planning to quit immediately, have unstable medical or psychiatric conditions, or are taking medications that affect nicotine metabolism are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the results could help regulators design nicotine standards and pricing policies that reduce harmful smoking while minimizing shifts to illegal cigarette markets.

How similar studies have performed: Previous laboratory and experimental marketplace studies of very-low-nicotine cigarettes and price changes have shown reductions in cigarette use, but effects specifically on illegal cigarette purchasing are less well established.

Eligibility criteria

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

Exclusion Criteria:

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

Where this trial is running

Roanoke, Virginia

• Fralin Biomedical Research Institute at Virginia Tech Carilion — Roanoke, Virginia, United States (Recruiting)

Study contacts

• Principal investigator: Roberta Freitas-Lemos, PhD — Fralin Biomedical Research Institute at Virginia Tech Carilion
• Study coordinator: Kirstin Gatchalian

Conditions Cigarette Smoking; E-cigarette Use; Experimental Tobacco Marketplace; Illegal cigarette