Cigar Smoking, Tobacco Use
Conditions
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).
Interventions
OTHERCigarillo 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
OTHERCigarillo 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
OTHERCigarillo 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
Sponsors
University of Oklahoma
National Institute on Drug Abuse (NIDA)
West Virginia University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Other
Eligibility
Sex/Gender
ALL
Age
18 Years to 24 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Puff number | From enrollment to the end of the final smoking visit, approximately 2 weeks | Number of cigarillo puffs |
| Subjective reward from smoking | 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 |
Countries
United States
Contacts
CONTACTProject Manager
PRINCIPAL_INVESTIGATORAmy Cohn, OhD
University of Oklahoma Health Sciences
Outcome results
None listed