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NCT Number: NCT07162935

Cigar Legislation and Regulation in Tobacco for the Young (Project CLARITY)

This clinical trial will recruit young adults who currently use cigarillos and examine the smoking behavior and perceptions of different flavored cigarillos, product ingredients/additives impacting these perceptions, and simulated tobacco use outcomes (quitting, switching) in various policy scenarios where different types of flavors are available on the market.

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Key information

Conditions

Cigar Smoking Behavior Smoking Tobacco Smoking Tobacco Use

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oklahoma Health Campus, Oklahoma City, Oklahoma, United States

Loading trial locations.

About this study

This clinical trial will isolate the unique effects of concept descriptors on increased cigarillo use and appeal among experienced young adult cigarillo users. The study will seek to determine the addiction potential of concept flavored cigarillos by examining associations of cigarillo flavor type (concept, characterizing, tobacco) and cigarillo flavoring additives/ingredients to complementary measures of product appeal: subjective effects (e.g., satisfaction, reward, taste), actual smoking behavior (e.g., number of puffs), and simulated cigarillo purchasing, other tobacco product substitution, or quitting under different flavor ban scenarios via an Experimental Tobacco Marketplace (ETM).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Cigarillo brand 1

Other

Participants will be assessed on puffing behavior, subjective effects, and exhaled carbon monoxide when assigned to using one of three cigarillo brands. Additives and ingredients of the cigarillo used will also be assessed

Cigarillo brand 2

Other

Participants will be assessed on puffing behavior, subjective effects, and exhaled carbon monoxide when assigned to using one of three cigarillo brands. Additives and ingredients of the cigarillo used will also be assessed

Cigarillo brand 3

Other

Participants will be assessed on puffing behavior, subjective effects, and exhaled carbon monoxide when assigned to using one of three cigarillo brands. Additives and ingredients of the cigarillo used will also be assessed

Primary outcomes

  1. Puff number

    Time frame: From enrollment to the end of the final smoking visit, approximately 2 weeks

    Number of cigarillo puffs

  2. Subjective reward from smoking

    Time frame: From enrollment to the end of the final smoking visit, approximately 2 weeks

    Self-reported reward from cigarillo smoking from a questionnaire. This scale has 5 questions with response options ranging from 1 - not at all to 7 - extremely. The score is averaged across the number of items. Higher ratings indicate greater psychological reward

Study contacts

Contact information is provided by the study sponsor or research team.

Project Manager

CONTACT

[email protected]

405-271-7759

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • West Virginia University

Registry information

Official study title

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

Acronym: CLARITY

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Sep 9, 2025
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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