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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flavor | Other | Either a sweet-flavored or a non-flavored cigarillo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flavor | Other | Sweet flavored vs. non-flavored cigarillos. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Laboratory visit 3 (Day 3, 2.5 hours) |
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Inclusion Criteria:
Exclusion Criteria:
Smoking Behavior
Alcohol and Drug
Medical
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.
Current or recent use of anti-psychotic medications.
General Exclusion
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38050181 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Flavor | Either a sweet-flavored or a non-flavored cigarillo Flavor: Sweet flavored vs. non-flavored cigarillos. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 95 adults reporting cigarillo use attended the baseline visit and enrolled in the study. Among these, 9 participants were excluded from the analysis; 2 participants withdrew from the study due to lack of interest and time commitment issues, while 7 did not attend all three visits, leaving 86 participants to comprise the analytic sample.
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| ID | Title | Description |
|---|---|---|
| BG000 | Flavor | Either a sweet-flavored or a non-flavored cigarillo Flavor: Sweet flavored vs. non-flavored cigarillos. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Laboratory visit 1 (Day 1, 1.5 hours) |
|
3 weeks
Serious Adverse Events were defined as any severe or serious medical event definitely related to study participation.
Adverse Events were defined as any unanticipated medical event definitely related to study participation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Flavor | Either a sweet-flavored or a non-flavored cigarillo Flavor: Sweet flavored vs. non-flavored cigarillos. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Participant vomited in smoking lab sink after taking cigarillo puffs during Lab visit 2. | General disorders | Systematic Assessment | Took 2 cigarillo puffs, felt nauseous then vomited. Attributed it to no food in >12 hours. Reported feeling better after vomiting. Declined to go home, seek medical care, or discontinue participation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janet Audrain-McGovern, Ph.D. Director, Addictions, Department of Psychiatry | Perelman School of Medicine, University of Pennsylvania | (215) 746-7145 | audrain@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 14, 2022 | Oct 17, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 26, 2022 | Oct 17, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| D000073863 | Cigar Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
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| ID | Term |
|---|---|
| D005421 | Flavoring Agents |
| ID | Term |
|---|---|
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D005503 | Food Additives |
| D000074385 | Food Ingredients |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Cigarillo Use | Cigarillo use was measured at baseline and included a frequent (use in the past day or week) and infrequent (use in the past month or greater) cigarillo use indicator. | Count of Participants | Participants |
|
| Cigarillo Flavor Preference | Cigarillo flavor preference was ascertained by asking 'During the day(s) that you smoked cigarillos, how often were they flavored?' with response options dichotomized into flavor ('Most of the time/Always') and non-flavored ('Sometimes/Rarely/Never') binary indicator. | Count of Participants | Participants |
|
| Cigarette Use | Use of combustible cigarettes was ascertained by indicators of frequent (use in the past day or week), infrequent (use in the past month or greater), and never (no lifetime use). | Count of Participants | Participants |
|
| Blunt Use | A blunt is made by taking out some or all of the tobacco in a cigarillo and replacing it with marijuana. The use of cigarillos for blunts was measured and differentiated from cigarillo tobacco use as intended. Blunt use was ascertained by indicators of frequent (use in the past day or week), infrequent (use in the past month or greater), and never (no lifetime use). | Count of Participants | Participants |
|
| Flavored Risk Perceptions | Risk perceptions of flavored cigarillo use were measured with an average sum of two items (i.e., 'Flavored cigarillos are less harmful than non-flavored cigarillos' and 'Flavored cigarillos are less addictive than non-flavored cigarillos.') with Likert-style scaling (0=not at all to 6=extremely). The minimum score is 0 and the maximum is 6. Higher scores indicate lower risk perceptions. | Mean | Standard Deviation | units on a scale |
|
| Cigarillo Dependence | The HONC (hooked on nicotine checklist) adapted for cigarillo use is a 10-question checklist with higher scores indicating greater loss of autonomy and the onset of cigarillo dependence. Responses were scored by tallying the number of yes responses (yes=1 and no=0). Cigarillo dependence can range from 0 (low) to 10 (high). | Mean | Standard Deviation | units on a scale |
|
| Advertising Exposure | Exposure to cigarillo advertising and marketing practices was measured with items adapted from PATH and prior research. A composite cigarillo advertising exposure averaged (α=.71) the 10 items which evaluated the type (flavor and non-flavored), frequency, and source (e.g., Internet, television, newspaper, retail stores, or outdoor locations) of exposure on a 5-point Likert type scale (1=never to 5=always). | Mean | Standard Deviation | units on a scale |
|
| Receives Marketing Promotions | Exposure to cigarillo advertising and marketing practices was measured with items adapted from PATH and prior research. Exposure to cigarillo promotions included a binary variable indicating any receipt (yes/no) of any type (mail, email, text, or another way) of cigarillo promotional material (e.g., giveaways, direct mail and e-mail coupons, links to online vendors, branded merchandise, celebrity endorsement, music event sponsorship). | Count of Participants | Participants |
|
| E-cigarette Use | Use of e-cigarettes was ascertained by indicators of frequent (use in the past day or week), infrequent (use in the past month or greater), and never (no lifetime use). | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | trials | Laboratory visit 2 (Day 2, 2 hours) |
|
|
|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | puffs | Laboratory visit 3 (Day 3, 2.5 hours) |
|
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| 0 |
| 86 |
| 0 |
| 86 |
| 1 |
| 86 |
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| D020313 |
| Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |