Cigar Legislation and Regulation in Tobacco for the Young (Project CLARITY)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-24
SponsorUniversity of Oklahoma
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Cigarillo brand 1
Other interventionParticipants 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 interventionParticipants 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 interventionParticipants 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
Treatment groups
300 Participants
are divided into 3 treatment groupsGroup A: Concept flavorExperimental treatment 3 interventions
Group B: Characterizing flavorExperimental treatment 3 interventions
Group C: Tobacco flavorExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Puff number
Number of cigarillo puffs
Time frame
From enrollment to the end of the final smoking visit, approximately 2 weeks2
Subjective reward from smoking
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
Time frame
From enrollment to the end of the final smoking visit, approximately 2 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Oklahoma
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
West Virginia University
Collaborator
Source ClinicalTrials.gov