How cigarillo flavor rules affect young adult cigarillo use (Project CLARITY)

Addiction Potential, Flavoring Content, and Substitutability of Concept Flavored Cigarillos

This study will test whether different cigarillo flavor types and additives make cigarillos more appealing and change smoking, switching, or quitting behavior in 18–24-year-olds who currently use cigarillos.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 24 Years
• Sex: All
• Sponsor: University of Oklahoma (Academic / other)
• Locations: 2 sites (Oklahoma City, Oklahoma and 1 other locations)
• Trial ID: NCT07162935 on ClinicalTrials.gov

What this trial studies

Project CLARITY will enroll 18–24-year-old cigarillo users and expose them to cigarillos labeled with different flavor types (concept, characterizing, and tobacco) to isolate the effects of flavor descriptors and additives. Researchers will collect subjective ratings (satisfaction, reward, taste), measure actual smoking behavior such as number of puffs in lab sessions, and analyze how additives relate to these outcomes. Participants will also complete simulated purchasing tasks in an Experimental Tobacco Marketplace that model different flavor ban scenarios to see whether they would quit, switch products, or continue using cigarillos. The trial combines controlled product exposures and behavioral economic simulation across two U.S. sites to inform how flavor policies may influence young adult tobacco use.

Who should consider this trial

Good fit: Ideal participants are U.S. citizens or permanent residents aged 18–24 who used a cigarillo in the past 30 days, have tried flavored tobacco before, can read English at an eighth-grade level, are not using cessation medications, and have no major smoking-related health problems.

Not a fit: People older than 24, those who do not use cigarillos or who are currently trying to quit with cessation medications, pregnant or breastfeeding individuals, and non–English speakers are unlikely to benefit from joining this study.

Why it matters

Potential benefit: If successful, the findings could help shape flavor policies that reduce cigarillo appeal among young adults and lower initiation and continued use.

How similar studies have performed: Previous laboratory and survey research has shown flavors increase appeal and likelihood of use and Experimental Tobacco Marketplace methods have been used successfully to model product switching, so this approach builds on established methods.

Eligibility criteria

Inclusion Criteria:

1. Ages 18 to 24
2. Report past 30-day use of a cigarillo
3. Ability to read English at least an 8th grade level
4. No immediate plans to quit using tobacco
5. At least 1 prior experience with a flavored tobacco product
6. U.S. Citizen or permanent resident of the United States.

Exclusion Criteria:

1. Current use of smoking cessation pharmacotherapy or nicotine replacement therapy;
2. Pregnant, planning to become pregnant, or currently breastfeeding;
3. Past or current clinically significant heart disease or hypertension, or other smoking-related disease that could preclude successful study completion;
4. Inability to abstain from nicotine/tobacco products for at least 12 hours
5. Unwillingness to use the research cigarillos in the lab

Where this trial is running

Oklahoma City, Oklahoma and 1 other locations

• University of Oklahoma Health Campus — Oklahoma City, Oklahoma, United States (Recruiting)
• West Virginia University — Morgantown, West Virginia, United States (Not_yet_recruiting)

Study contacts

• Principal investigator: Amy Cohn, OhD — University of Oklahoma Health Sciences
• Study coordinator: Project Manager

Conditions Cigar Smoking; Tobacco Use