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

NCT ID: NCT07162935

Last Updated: 2025-10-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2030-05-31

Brief Summary

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.

Detailed Description

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).

Conditions

Cigar Smoking; Tobacco Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Concept flavor

Participants will be randomized to smoke one of the three assigned concept flavored cigarillos

Group Type: EXPERIMENTAL

Cigarillo brand 1

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Characterizing flavor

Participants will be randomized to smoke one of the three assigned characterizing flavored cigarillos

Group Type: EXPERIMENTAL

Cigarillo brand 1

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Tobacco flavor

Participants will be randomized to smoke a tobacco flavored cigarillo

Group Type: EXPERIMENTAL

Cigarillo brand 1

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Interventions

Cigarillo brand 1

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

Intervention Type: OTHER

Cigarillo brand 2

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

Intervention Type: OTHER

Cigarillo brand 3

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

West Virginia University

OTHER

Sponsor Role: collaborator

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amy Cohn, OhD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma Health Sciences

Locations

West Virginia University

Morgantown, West Virginia, United States

Countries

United States

Central Contacts

Project Manager

Role: CONTACT

heal-lab@ouhsc.edu

405-271-7759

Facility Contacts

Project Manager

Role: primary

wvutobaccolab@mail.wvu.edu

304-293-0551

Other Identifiers

R01DA062632-01

Identifier Type: NIH

Identifier Source: secondary_id

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Clarity

Identifier Type: -

Identifier Source: org_study_id