Cigar SmokingCLARITYNCT07162935
Cigar Legislation and Regulation in Tobacco for the Young (Project CLARITY)
A study testing Cigarillo brand 1, Cigarillo brand 2 and Cigarillo brand 3 in people with Cigar Smoking and Tobacco Use, run by University of Oklahoma at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigar Smoking, Tobacco Use
- What is being tested?
- Cigarillo brand 1, Cigarillo brand 2 and Cigarillo brand 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Feb 2026to 31 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
- At least 1 prior experience with a flavored tobacco product
- U.S. Citizen or permanent resident of the United States.
Who cannot join
- 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
- Unwillingness to use the research cigarillos in the lab
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
West Virginia University
Morgantown, West Virginia, 26506
Project Manager, 304-293-0551, wvutobaccolab@mail.wvu.edu
Melissa Blank, PhD
- Recruiting
University of Oklahoma Health Campus
Oklahoma City, Oklahoma, 73104
Amy Cohn Principal Investigator, PhD, 405-271-7759, heal-lab@ouhsc.edu
Michael Smith Project Manager, MPH, MS, CHES
About this study
Official title: Addiction Potential, Flavoring Content, and Substitutability of Concept Flavored Cigarillos
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.
Read the 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
- Being tested
- Cigarillo brand 1, Cigarillo brand 2, Cigarillo brand 3
- Medical subject headings
- Cigar Smoking, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cigarillo brand 1Other
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 2Other
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 3Other
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
| Study group | Role | What they receive |
|---|---|---|
| Concept flavor | Experimental | Participants will be randomized to smoke one of the three assigned concept flavored cigarillos Receives: Other: Cigarillo brand 1; Other: Cigarillo brand 2; Other: Cigarillo brand 3 |
| Characterizing flavor | Experimental | Participants will be randomized to smoke one of the three assigned characterizing flavored cigarillos Receives: Other: Cigarillo brand 1; Other: Cigarillo brand 2; Other: Cigarillo brand 3 |
| Tobacco flavor | Experimental | Participants will be randomized to smoke a tobacco flavored cigarillo Receives: Other: Cigarillo brand 1; Other: Cigarillo brand 2; Other: Cigarillo brand 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Puff number
Number of cigarillo puffs
Measured: From enrollment to the end of the final smoking visit, approximately 2 weeks
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
Measured: From enrollment to the end of the final smoking visit, approximately 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start23 Feb 2026
- Primary completion2 Mar 2030 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigar SmokingStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Other
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), West Virginia University
- Responsible party
- Sponsor
- Investigators
- Amy Cohn, OhD, Principal investigator, University of Oklahoma Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162935
- Sponsor's protocol ID
- Clarity
- Other IDs
- R01DA062632-01
- Acronym
- CLARITY
- Status last verified
- May 2026
- First submitted
- 2 Sep 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data that are determined to be private (name, address, email address) will be provided under a restricted data use contract to those who demonstrate a valid need and meet the conditions of use
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addiction Potential, Flavoring Content, and Substitutability of Concept Flavored Cigarillos
- ClinicalTrials.gov ID
- NCT07162935
- Acronym / sponsor ID
- CLARITY / Clarity
- Conditions
- Cigar Smoking, Tobacco Use
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), West Virginia University
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 2 Mar 2030 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Other
| Arm | Type | Receives |
|---|---|---|
| Concept flavor | Experimental | Other: Cigarillo brand 1, Other: Cigarillo brand 2, Other: Cigarillo brand 3Participants will be randomized to smoke one of the three assigned concept flavored cigarillos |
| Characterizing flavor | Experimental | Other: Cigarillo brand 1, Other: Cigarillo brand 2, Other: Cigarillo brand 3Participants will be randomized to smoke one of the three assigned characterizing flavored cigarillos |
| Tobacco flavor | Experimental | Other: Cigarillo brand 1, Other: Cigarillo brand 2, Other: Cigarillo brand 3Participants will be randomized to smoke a tobacco flavored cigarillo |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
- At least 1 prior experience with a flavored tobacco product
Key exclusion criteria (5 listed)
- 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
- Unwillingness to use the research cigarillos in the lab
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cigarillo brand 1Participants 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 | Characterizing flavor, Concept flavor, Tobacco flavor |
| Cigarillo brand 2Participants 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 | Characterizing flavor, Concept flavor, Tobacco flavor |
| Cigarillo brand 3Participants 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 | Characterizing flavor, Concept flavor, Tobacco flavor |
Primary outcome
Puff number
Time frame: From enrollment to the end of the final smoking visit, approximately 2 weeks
Number of cigarillo puffs
Subjective reward from smoking
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: Yes. Data that are determined to be private (name, address, email address) will be provided under a restricted data use contract to those who demonstrate a valid need and meet the conditions of use
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy Cohn, OhD principal investigator
University of Oklahoma Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cigarillo brand 1, Cigarillo brand 2 and Cigarillo brand 3 in people with Cigar Smoking and Tobacco Use, run by University of Oklahoma at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Project Manager (405-271-7759, heal-lab@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Puff number (time frame: From enrollment to the end of the final smoking visit, approximately 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.