Tobacco UseEarly Phase 1FLAVNCT05092919
The Effect of Sweet Flavoring on the Rewarding and Reinforcing Value of Cigarillo Use Among Young Adults
A Early Phase 1 study testing Flavor in people with Tobacco Use and Cigar Smoking, run by University of Pennsylvania at 1 site in United States.
Trial summary
This within-subjects study aims to evaluate the subjective rewarding value, the relative reinforcing value, and the absolute reinforcing value of sweet flavored cigarillos across three separate laboratory visits among 86 young adults (ages 18-24 years old) who have previously smoked > 10 or more cigarillos in their… Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use, Cigar Smoking
- What is being tested?
- Flavor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2021to 31 May 2023
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Able to communicate fluently in English (i.e. speaking, writing, and reading).
- Male and female young adults who are between 18 and 24 years of age who have used > 10 cigarillos in their lifetime.
- Not currently undergoing smoking cessation treatment or planning to quit smoking cigarettes within the next 30 days.
- Plan to live in the area for the duration of the study.
- Willing to use study-provided cigarillos during three laboratory visits.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.
Who cannot join
- Smoking Behavior
- Use of less than 10 cigarillos in lifetime
- Current enrollment or plans to enroll in a tobacco cessation program over the duration of the study.
- Current use of nicotine replacement therapy or other smoking cessation medication.
- Alcohol and Drug
- History of substance abuse (other than nicotine dependence) in the past 12 months and/or currently receiving medical treatment for substance abuse. Counseling and support groups (e.g. Alcoholics Anonymous and Narcotics Anonymous) will not be considered medical treatment for the purposes of this protocol.
Show all 24Show fewer
- Current alcohol consumption that exceeds 25 standard drinks/week.
- Breath alcohol reading (BrAC) greater than .000 at Laboratory Visit 1.
- Use of e-cigarettes on >5 days in the past 30 days.
- Medical
- Women, including all individuals assigned as "female" at birth, who are pregnant, breast feeding, or planning a pregnancy over the duration of the study period.
- Serious or unstable disease within the past year (e.g. cancer, heart disease). Applicable conditions will be evaluated on a case-by-case basis by the Principal Investigator.
- Psychiatric
- Lifetime history of schizophrenia or psychosis
- Lifetime history of a suicide attempt.
- Current use of medications used to treat mood, such as depression or anxiety.
- Individuals will be excluded if they take psychotropic medications that may impact laboratory assessments of nicotine/flavoring reward and reinforcement.
- Participants with a history of depression or anxiety will not be excluded- however, participants who are currently taking any medications used to treat these will be ineligible to participate.
- Participants who are not currently taking these medications but are receiving treatment such as therapy or counseling will be eligible to participate.
- Current or recent use of anti-psychotic medications.
- General Exclusion
- Past, current, anticipated, or pending enrollment in another research program over the study period that could potentially impact subject safety, study data, and/or the study design as determined by the Principal Investigator.
- Any medical condition, illness, disorder, adverse event (AE), or concomitant medication that could compromise participant safety or significantly impact study performance as determined by the Principal Investigator. Subjects may be deemed ineligible for any of the aforementioned reasons at any point throughout the study, as well as during the initial telephone screen.
- Significant non-compliance with protocol and/or study design as determined by the Principal Investigator. Subjects may be deemed ineligible at any point throughout the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
This within-subjects study aims to evaluate the subjective rewarding value, the relative reinforcing value, and the absolute reinforcing value of sweet flavored cigarillos across three separate laboratory visits among 86 young adults (ages 18-24 years old) who have previously smoked > 10 or more cigarillos in their lifetime.
- Conditions
- Tobacco Use, Cigar Smoking
- Being tested
- Flavor
- Medical subject headings
- Tobacco Use, Cigar Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlavorOther
Sweet flavored vs. non-flavored cigarillos.
| Study group | Role | What they receive |
|---|---|---|
| Flavor | Other | Either a sweet-flavored or a non-flavored cigarillo Receives: Other: Flavor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Rewarding Value of Cigarillo Flavoring
Subjective rewarding value of cigarillo flavoring will be measured with the Cigarette Evaluation Scale (CES) adapted for cigarillo use. The CES is an 11 item Likert-format (1=not at all to 7=extremely) self-report instrument with established validity and reliability (α > .80). The investigators will focus on the sum of the two-item satisfaction subscale ("Was it satisfying?" and "Did it taste good?") to calculate the subjective rewarding value. The minimum possible score is 2 and the maximum is 14. Higher scores denote greater subjective rewarding value. Primary Outcome measured at visit 1.
Measured: Laboratory visit 1 (Day 1, 1.5 hours)
Relative Reinforcing Value of Cigarillo Flavoring
Relative reinforcing value of cigarillo flavoring will be measured with a validated choice paradigm, evaluating the preference for sweet flavored (the cigarillo with the highest rewarding value measured in visit 1) relative to non-flavored cigarillos. The reinforcement schedule in the non-flavored cigarillo remained constant at a fixed ratio FR-25, while the reinforcement schedule for the sweet-flavored cigarillo increased with a progressive ratio schedule of PR-25x over 10 trials. RRVF will be defined by the breakpoint (highest trial completed across 10 trials to earn puffs for sweet flavored versus non-flavored cigarillos). Higher breakpoints indicate a greater relative reinforcing value. Primary Outcome measured at visit 2.
Measured: Laboratory visit 2 (Day 2, 2 hours)
Absolute Reinforcing Value of Cigarillo Flavoring
Absolute reinforcing value of cigarillo flavoring is operationalized as the number of sweet flavored versus non-flavored cigarillo puffs consumed during the ad libitum smoking session. A research assistant will videotape, monitor, and count the number of cigarillo puffs taken during the 90-minute period. The primary comparison is the amount of consumption (puffs) of the sweet flavored (determined at visit 1) versus non-flavored cigarillo. A greater number of puffs indicates a higher absolute reinforcing value. Primary Outcome measured at visit 3.
Measured: Laboratory visit 3 (Day 3, 2.5 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start14 Sep 2021
- Primary completion28 Feb 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janet Audrain-McGovern, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05092919
- Sponsor's protocol ID
- 843944
- Acronym
- FLAV
- Status last verified
- Apr 2024
- First submitted
- 30 Sep 2021
- Last updated
- 17 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Audrain-McGovern J, Manikandan D, Koita F, Klapec O, Pickworth WB, Stone MD. Effect of sweet flavouring on the rewarding and reinforcing value of cigarillo use among young adults. Tob Control. 2025 May 15;34(3):294-301. doi: 10.1136/tc-2023-058307.
PubMed 38050181
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sweet Flavoring on the Rewarding and Reinforcing Value of Cigarillo Use Among Young Adults
- ClinicalTrials.gov ID
- NCT05092919
- Acronym / sponsor ID
- FLAV / 843944
- Conditions
- Tobacco Use, Cigar Smoking
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 26 Oct 2021 (actual)
- Results
- Posted 17 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This within-subjects study aims to evaluate the subjective rewarding value, the relative reinforcing value, and the absolute reinforcing value of sweet flavored cigarillos across three separate laboratory visits among 86 young adults (ages 18-24 years old) who have previously smoked > 10 or more cigarillos in their lifetime.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flavor | Other | Other: FlavorEither a sweet-flavored or a non-flavored cigarillo |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Able to communicate fluently in English (i.e. speaking, writing, and reading).
- Male and female young adults who are between 18 and 24 years of age who have used > 10 cigarillos in their lifetime.
- Not currently undergoing smoking cessation treatment or planning to quit smoking cigarettes within the next 30 days.
- Plan to live in the area for the duration of the study.
- Willing to use study-provided cigarillos during three laboratory visits.
Key exclusion criteria (24 listed)
- Smoking Behavior
- Use of less than 10 cigarillos in lifetime
- Current enrollment or plans to enroll in a tobacco cessation program over the duration of the study.
- Current use of nicotine replacement therapy or other smoking cessation medication.
- Alcohol and Drug
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 |
|---|---|---|
| FlavorSweet flavored vs. non-flavored cigarillos. | Other | Flavor |
Primary outcome
Subjective Rewarding Value of Cigarillo Flavoring
Time frame: Laboratory visit 1 (Day 1, 1.5 hours)
Subjective rewarding value of cigarillo flavoring will be measured with the Cigarette Evaluation Scale (CES) adapted for cigarillo use. The CES is an 11 item Likert-format (1=not at all to 7=extremely) self-report instrument with established validity and reliability (α > .80). The investigators will focus on the sum of the two-item satisfaction subscale ("Was it satisfying?" and "Did it taste good?") to calculate the subjective rewarding value. The minimum possible score is 2 and the maximum is 14. Higher scores denote greater subjective rewarding value. Primary Outcome measured at visit 1.
Relative Reinforcing Value of Cigarillo Flavoring
Time frame: Laboratory visit 2 (Day 2, 2 hours)
Relative reinforcing value of cigarillo flavoring will be measured with a validated choice paradigm, evaluating the preference for sweet flavored (the cigarillo with the highest rewarding value measured in visit 1) relative to non-flavored cigarillos. The reinforcement schedule in the non-flavored cigarillo remained constant at a fixed ratio FR-25, while the reinforcement schedule for the sweet-flavored cigarillo increased with a progressive ratio schedule of PR-25x over 10 trials. RRVF will be defined by the breakpoint (highest trial completed across 10 trials to earn puffs for sweet flavored versus non-flavored cigarillos). Higher breakpoints indicate a greater relative reinforcing value. Primary Outcome measured at visit 2.
Absolute Reinforcing Value of Cigarillo Flavoring
Time frame: Laboratory visit 3 (Day 3, 2.5 hours)
Absolute reinforcing value of cigarillo flavoring is operationalized as the number of sweet flavored versus non-flavored cigarillo puffs consumed during the ad libitum smoking session. A research assistant will videotape, monitor, and count the number of cigarillo puffs taken during the 90-minute period. The primary comparison is the amount of consumption (puffs) of the sweet flavored (determined at visit 1) versus non-flavored cigarillo. A greater number of puffs indicates a higher absolute reinforcing value. Primary Outcome measured at visit 3.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38050181Audrain-McGovern J, Manikandan D, Koita F, Klapec O, Pickworth WB, Stone MD. Effect of sweet flavouring on the rewarding and reinforcing value of cigarillo use among young adults. Tob Control. 2025 May 15;34(3):294-301. doi: 10.1136/tc-2023-058307.
- Individual participant dataSharing planned: Yes
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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 Early Phase 1 study testing Flavor in people with Tobacco Use and Cigar Smoking, run by University of Pennsylvania 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 24 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 17 May 2024. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Rewarding Value of Cigarillo Flavoring (time frame: Laboratory visit 1 (Day 1, 1.5 hours)). 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?
On the ClinicalTrials.gov record for NCT05092919, which also lists 1 linked publication.
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 May 2024.