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

Purpose

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.

Conditions

  • Cigar Smoking
  • Tobacco Use

Eligibility

Eligible Ages
Between 18 Years and 24 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Other
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Concept flavor 		Participants will be randomized to smoke one of the three assigned concept flavored cigarillos
  • Other: 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
  • 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
  • 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
Experimental
Characterizing flavor 		Participants will be randomized to smoke one of the three assigned characterizing flavored cigarillos
  • Other: 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
  • 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
  • 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
Experimental
Tobacco flavor 		Participants will be randomized to smoke a tobacco flavored cigarillo
  • Other: 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
  • 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
  • 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

Recruiting Locations

University of Oklahoma Health Campus
Oklahoma City, Oklahoma 73104
Contact:
Amy Cohn Principal Investigator, PhD
405-271-7759
heal-lab@ouhsc.edu

More Details

Status
Recruiting
Sponsor
University of Oklahoma

Study Contact

Project Manager
405-271-7759
heal-lab@ouhsc.edu

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).