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

University of Oklahoma (OU)

Status: Not yet enrolling

Conditions: Cigar Smoking; Tobacco Use

Treatments: Other: Cigarillo brand 3; Other: Cigarillo brand 2; Other: Cigarillo brand 1

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07162935

Clarity

R01DA062632-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 24 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

Concept flavor

Experimental group

Description:

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

Treatment:

Other: Cigarillo brand 1

Other: Cigarillo brand 2

Other: Cigarillo brand 3

Characterizing flavor

Experimental group

Description:

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

Treatment:

Other: Cigarillo brand 1

Other: Cigarillo brand 2

Other: Cigarillo brand 3

Tobacco flavor

Experimental group

Description:

Participants will be randomized to smoke a tobacco flavored cigarillo

Treatment:

Other: Cigarillo brand 1

Other: Cigarillo brand 2

Other: Cigarillo brand 3