Tobacco UseASPIRENCT06617520
Attitudes and Smoking Perceptions in the Real Environment
A study testing Cigarillo flavor type in people with Tobacco Use, run by University of Oklahoma at 1 site in United States.
Trial summary
This study will measure appeal and reinforcement for different flavored little cigars/cigarillos (LCCs) in young adults in the laboratory and at-home, via ecological momentary assessment (daily smart-phone surveys) Read more about this study
- Who is it for?
- Ages 18 to 34 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use
- What is being tested?
- Cigarillo flavor type
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2024to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 little cigars/cigarillos (LCCs) "some days" or "everyday"
- Ability to read English at an 8th grade level or higher
- No immediate plans to quit using tobacco
Who cannot join
- Current use of nicotine replacement therapy (NRT)
- 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 each of two study 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.
United States1 site
TSET Health Promotion Research Center
Oklahoma City, Oklahoma, 73104
About this study
This study will measure appeal and reinforcement for different flavored little cigars/cigarillos (LCCs) in young adults in the laboratory and at-home, via ecological momentary assessment (daily smart-phone surveys)
Read the detailed description
Participants will attend 4 laboratory sessions that differ by cigarillo smoked: own brand and a then commercially available study cigarillo (Garcia y Vega game cigarillo) in tobacco flavor, concept flavor, and characterizing flavor. Consistent with our work and other's published work8-10, a baseline (BL) period will measure appeal to smoking one's usual brand cigarillo in their home environment for 7 days and then once in the laboratory (>12-hour abstinence), at the end of the 7 days. Participants will then undergo 3 experimental conditions (counterbalanced, within-subjects): (1) 7 days smoking a concept flavored study cigarillo; (2) 7 days smoking a characterizing flavored study cigarillo; and (3) 7 days smoking a tobacco flavored study cigarillo. Participants will be instructed to switch their usual brand cigarillo for the assigned study cigarillo for each 7-day period. Other tobacco use will be allowed during that time without specific instruction to model real-world behavior. On the last day of each 7-day period of "take home" use, abstinent participants (>12 hours) will smoke the assigned study cigarillo in the lab ad libitum, where subjective effects (e.g., satisfaction, craving reduction, psychological reward, throat hit), smoke exposure (CO boost), and behavior (e.g., number of puffs) will be assessed During each 7-day period of exposure, participants will complete assessments of cigarillo and other tobacco use and subjective effects to cigarillo use via once daily EMA.
- Conditions
- Tobacco Use
- Being tested
- Cigarillo flavor type
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cigarillo flavor typeOther
Participants will complete a within-subjects design that varies by cigarillo smoked: tobacco flavor, concept flavor, and characterizing flavor
| Study group | Role | What they receive |
|---|---|---|
| Tobacco flavor cigarillo | Experimental | A participant will use a tobacco flavored cigarillo at home for 7-days, as they wish, and then smoke it once in the laboratory Receives: Other: Cigarillo flavor type |
| Concept flavor cigarillo | Experimental | A participant will use a concept flavored cigarillo at home for 7-days, as they wish, and then smoke it once in the laboratory Receives: Other: Cigarillo flavor type |
| Characterizing flavor | Experimental | A participant will use a characterizing flavored cigarillo at home for 7-days, as they wish, and then smoke it once in the laboratory Receives: Other: Cigarillo flavor type |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective response to smoking
average ratings of psychological reward following smoking from Modified Cigarette Evaluation Scale. Higher scores indicate higher reward. Score responses range from 1 to 7
Measured: Laboratory visits, up to 3 weeks after the baseline
Number of cigarillos smoked
The number of cigarillos smoked during each 7-day take-home period
Measured: Daily smartphone surveys, up to 3 weeks after the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start15 Apr 2024
- Primary completion15 Mar 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Presbyterian Health Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617520
- Sponsor's protocol ID
- ASPIRE
- Other IDs
- ST116745
- Acronym
- ASPIRE
- Status last verified
- Aug 2025
- First submitted
- 24 Sep 2024
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing may be available at the discretion and with the permission of the university and an approved data use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attitudes and Smoking Perceptions in the Real Environment
- ClinicalTrials.gov ID
- NCT06617520
- Acronym / sponsor ID
- ASPIRE / ASPIRE
- Conditions
- Tobacco Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Presbyterian Health Foundation
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 27 Sep 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 study will measure appeal and reinforcement for different flavored little cigars/cigarillos (LCCs) in young adults in the laboratory and at-home, via ecological momentary assessment (daily smart-phone surveys)
Detailed description
Participants will attend 4 laboratory sessions that differ by cigarillo smoked: own brand and a then commercially available study cigarillo (Garcia y Vega game cigarillo) in tobacco flavor, concept flavor, and characterizing flavor. Consistent with our work and other's published work8-10, a baseline (BL) period will measure appeal to smoking one's usual brand cigarillo in their home environment for 7 days and then once in the laboratory (>12-hour abstinence), at the end of the 7 days. Participants will then undergo 3 experimental conditions (counterbalanced, within-subjects): (1) 7 days smoking a concept flavored study cigarillo; (2) 7 days smoking a characterizing flavored study cigarillo; and (3) 7 days smoking a tobacco flavored study cigarillo. Participants will be instructed to switch their usual brand cigarillo for the assigned study cigarillo for each 7-day period. Other tobacco use will be allowed during that time without specific instruction to model real-world behavior. On the last day of each 7-day period of "take home" use, abstinent participants (>12 hours) will smoke the assigned study cigarillo in the lab ad libitum, where subjective effects (e.g., satisfaction, craving reduction, psychological reward, throat hit), smoke exposure (CO boost), and behavior (e.g., number of puffs) will be assessed During each 7-day period of exposure, participants will complete assessments of cigarillo and other tobacco use and subjective effects to cigarillo use via once daily EMA.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tobacco flavor cigarillo | Experimental | Other: Cigarillo flavor typeA participant will use a tobacco flavored cigarillo at home for 7-days, as they wish, and then smoke it once in the laboratory |
| Concept flavor cigarillo | Experimental | Other: Cigarillo flavor typeA participant will use a concept flavored cigarillo at home for 7-days, as they wish, and then smoke it once in the laboratory |
| Characterizing flavor | Experimental | Other: Cigarillo flavor typeA participant will use a characterizing flavored cigarillo at home for 7-days, as they wish, and then smoke it once in the laboratory |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ages18 to 34
- Smoke little cigars/cigarillos (LCCs) "some days" or "everyday"
- Ability to read English at an 8th grade level or higher
- No immediate plans to quit using tobacco
Key exclusion criteria (5 listed)
- Current use of nicotine replacement therapy (NRT)
- 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 each of two study 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.
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 flavor typeParticipants will complete a within-subjects design that varies by cigarillo smoked: tobacco flavor, concept flavor, and characterizing flavor | Other | Characterizing flavor, Concept flavor cigarillo, Tobacco flavor cigarillo |
Primary outcome
Subjective response to smoking
Time frame: Laboratory visits, up to 3 weeks after the baseline
average ratings of psychological reward following smoking from Modified Cigarette Evaluation Scale. Higher scores indicate higher reward. Score responses range from 1 to 7
Number of cigarillos smoked
Time frame: Daily smartphone surveys, up to 3 weeks after the baseline
The number of cigarillos smoked during each 7-day take-home period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Individual participant dataSharing planned: No. Sharing may be available at the discretion and with the permission of the university and an approved data use agreement.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cigarillo flavor type in people with Tobacco Use, 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 4 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: finished, as of the sponsor's last update on 27 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective response to smoking (time frame: Laboratory visits, up to 3 weeks after the baseline). 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 27 Aug 2025; AzTrials last refreshed its copy on 3 Nov 2026.