Cigarillo FlavorASPIRE-IINCT06668350
Attitudes and Perceptions Attitudes and Smoking Perceptions in the Real Environment -II
A study testing Smoking outcomes in people with Cigarillo Flavor, run by University of Oklahoma at 1 site in United States.
Trial summary
This multi-method project will recruit young adults who currently use cigarillos and examine the effects of different flavored cigarillo types (concept, characterizing, tobacco) on three measures of tobacco product appeal: subjective effects (e.g., taste, enjoyment, satisfaction, reward), actual smoking behavior… Read more about this study
- Who is it for?
- Ages 18 to 34 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarillo Flavor
- What is being tested?
- Smoking outcomes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2025to 30 Jun 2029
- 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 34 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages18 to 34
- Smoke a little cigar or cigarillo (LCCs) "some days" or "everyday" (verified by brand name of the product);
- Ability to read English at an 8th grade level or higher; and
- No immediate plans to quit using tobacco
- > 1 prior experience, even 1 puff, with a flavored tobacco product
- U.S. Citizen or permanent resident of the United States.
Who cannot join
- Current use of nicotine replacement therapy (NRT) or stop smoking medication;
- Pregnant, planning to become pregnant, or currently breastfeeding;
- Past or current self-reported clinically significant heart disease or hypertension, or other smoking-related disease (by history) that preclude successful study completion;
- Inability to abstain from nicotine/tobacco products for at least 12 hours prior to lab sessions
- Report using the study cigarillo brand as their preferred brand (as this will likely unduly influence their perceptions)
- Unwillingness to use "untipped" (e.g., plastic or wood tip) little cigars/cigarillos.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
TSET Health Promotion Research Center
Oklahoma City, Oklahoma, 73012
Project Manager, 405-271-1903, heal-lab@ouhsc.edu
Amy Cohn, PhD
About this study
Official title: Racial/Ethnic Differences in Appeal and Preference for Flavored Little Cigars/Cigarillos: A Multi-Method Approach to Inform Tobacco Policy
This multi-method project will recruit young adults who currently use cigarillos and examine the effects of different flavored cigarillo types (concept, characterizing, tobacco) on three measures of tobacco product appeal: subjective effects (e.g., taste, enjoyment, satisfaction, reward), actual smoking behavior (e.g., number of puffs), and tobacco product purchases via a simulated experimental tobacco marketplace.
- Conditions
- Cigarillo Flavor
- Being tested
- Smoking outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking outcomesOther
Participants will be assessed on several smoking outcomes including puffing behavior, subjective effects, and exhaled carbon monoxide
| Study group | Role | What they receive |
|---|---|---|
| Concept flavored cigarillo | Experimental | Participants will smoke a concept flavored cigarillo in the lab Receives: Other: Smoking outcomes |
| Characterizing flavored cigarillo | Experimental | Participants will smoke a characterizing flavored cigarillo Receives: Other: Smoking outcomes |
| Tobacco flavored cigarillo | Experimental | Participants will smoke a tobacco flavored cigarillo Receives: Other: Smoking outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Puff volume
Volume of inhaled cigarillo puffs
Measured: From enrollment to the end of the study at 6 weeks
Subjective effects 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 study at 6 weeks
Exhaled carbon monoxide
Changes in exhaled carbon monoxide (CO boot) following cigarillo smoking
Measured: From enrollment to the end of the study at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start27 Jun 2025
- Primary completion1 Feb 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarillo FlavorStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668350
- Sponsor's protocol ID
- ACS CHERC
- Other IDs
- CHERC-24-1160021-01-CHERC
- Acronym
- ASPIRE-II
- Status last verified
- Aug 2025
- First submitted
- 30 Oct 2024
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Racial/Ethnic Differences in Appeal and Preference for Flavored Little Cigars/Cigarillos: A Multi-Method Approach to Inform Tobacco Policy
- ClinicalTrials.gov ID
- NCT06668350
- Acronym / sponsor ID
- ASPIRE-II / ACS CHERC
- Conditions
- Cigarillo Flavor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 31 Oct 2024 (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 multi-method project will recruit young adults who currently use cigarillos and examine the effects of different flavored cigarillo types (concept, characterizing, tobacco) on three measures of tobacco product appeal: subjective effects (e.g., taste, enjoyment, satisfaction, reward), actual smoking behavior (e.g., number of puffs), and tobacco product purchases via a simulated experimental tobacco marketplace.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Concept flavored cigarillo | Experimental | Other: Smoking outcomesParticipants will smoke a concept flavored cigarillo in the lab |
| Characterizing flavored cigarillo | Experimental | Other: Smoking outcomesParticipants will smoke a characterizing flavored cigarillo |
| Tobacco flavored cigarillo | Experimental | Other: Smoking outcomesParticipants will smoke a tobacco flavored cigarillo |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Ages18 to 34
- Smoke a little cigar or cigarillo (LCCs) "some days" or "everyday" (verified by brand name of the product);
- Ability to read English at an 8th grade level or higher; and
- No immediate plans to quit using tobacco
- > 1 prior experience, even 1 puff, with a flavored tobacco product
Key exclusion criteria (6 listed)
- Current use of nicotine replacement therapy (NRT) or stop smoking medication;
- Pregnant, planning to become pregnant, or currently breastfeeding;
- Past or current self-reported clinically significant heart disease or hypertension, or other smoking-related disease (by history) that preclude successful study completion;
- Inability to abstain from nicotine/tobacco products for at least 12 hours prior to lab sessions
- Report using the study cigarillo brand as their preferred brand (as this will likely unduly influence their perceptions)
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 |
|---|---|---|
| Smoking outcomesParticipants will be assessed on several smoking outcomes including puffing behavior, subjective effects, and exhaled carbon monoxide | Other | Characterizing flavored cigarillo, Concept flavored cigarillo, Tobacco flavored cigarillo |
Primary outcome
Puff volume
Time frame: From enrollment to the end of the study at 6 weeks
Volume of inhaled cigarillo puffs
Subjective effects from smoking
Time frame: From enrollment to the end of the study at 6 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.
Exhaled carbon monoxide
Time frame: From enrollment to the end of the study at 6 weeks
Changes in exhaled carbon monoxide (CO boot) following cigarillo smoking
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 17 Aug 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Cigarillo Flavor
Recruiting
Cigar Legislation and Regulation in Tobacco for the Young (Project CLARITY)
Cigar Smoking, Tobacco Use
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking outcomes in people with Cigarillo Flavor, run by University of Oklahoma at 1 site 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 6 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 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (1-405-271-7759, 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 volume (time frame: From enrollment to the end of the study at 6 weeks). The study lists 3 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 17 Aug 2025.