Trial Outcomes & Findings for The Effect of Sweet Flavoring on the Rewarding and Reinforcing Value of Cigarillo Use Among Young Adults (NCT NCT05092919)
NCT ID: NCT05092919
Last Updated: 2024-05-17
Results Overview
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.
COMPLETED
EARLY_PHASE1
95 participants
Laboratory visit 1 (Day 1, 1.5 hours)
2024-05-17
Participant Flow
Participant milestones
| Measure |
Flavor
Either a sweet-flavored or a non-flavored cigarillo
Flavor: Sweet flavored vs. non-flavored cigarillos.
|
|---|---|
|
Overall Study
STARTED
|
95
|
|
Overall Study
COMPLETED
|
86
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Flavor
Either a sweet-flavored or a non-flavored cigarillo
Flavor: Sweet flavored vs. non-flavored cigarillos.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
The Effect of Sweet Flavoring on the Rewarding and Reinforcing Value of Cigarillo Use Among Young Adults
Baseline characteristics by cohort
| Measure |
Flavor
n=86 Participants
Either a sweet-flavored or a non-flavored cigarillo
Flavor: Sweet flavored vs. non-flavored cigarillos.
|
|---|---|
|
Age, Continuous
|
22.23 years
STANDARD_DEVIATION 1.57 • n=93 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
33 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
29 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Other
|
24 Participants
n=93 Participants
|
|
Cigarillo Use
Infrequent
|
58 Participants
n=93 Participants
|
|
Cigarillo Use
Frequent
|
28 Participants
n=93 Participants
|
|
Cigarillo Flavor Preference
Non-flavored
|
23 Participants
n=93 Participants
|
|
Cigarillo Flavor Preference
Flavored
|
63 Participants
n=93 Participants
|
|
Cigarette Use
Never
|
21 Participants
n=93 Participants
|
|
Cigarette Use
Infrequent
|
43 Participants
n=93 Participants
|
|
Cigarette Use
Frequent
|
22 Participants
n=93 Participants
|
|
Blunt Use
Never
|
9 Participants
n=93 Participants
|
|
Blunt Use
Infrequent
|
41 Participants
n=93 Participants
|
|
Blunt Use
Frequent
|
36 Participants
n=93 Participants
|
|
Flavored Risk Perceptions
|
1.41 units on a scale
STANDARD_DEVIATION 0.61 • n=93 Participants
|
|
Cigarillo Dependence
|
1.71 units on a scale
STANDARD_DEVIATION 2.26 • n=93 Participants
|
|
Advertising Exposure
|
3.24 units on a scale
STANDARD_DEVIATION 1.21 • n=93 Participants
|
|
Receives Marketing Promotions
|
12 Participants
n=93 Participants
|
|
E-cigarette Use
Never
|
19 Participants
n=93 Participants
|
|
E-cigarette Use
Infrequent
|
51 Participants
n=93 Participants
|
|
E-cigarette Use
Frequent
|
16 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Flavor
n=86 Participants
Either a sweet-flavored or a non-flavored cigarillo
Flavor: Sweet flavored vs. non-flavored cigarillos.
|
|---|---|
|
Subjective Rewarding Value of Cigarillo Flavoring
Citrus "Jazz"
|
4.03 score on a scale
Standard Deviation 1.47
|
|
Subjective Rewarding Value of Cigarillo Flavoring
Cream
|
3.63 score on a scale
Standard Deviation 1.42
|
|
Subjective Rewarding Value of Cigarillo Flavoring
Non-flavored
|
3.30 score on a scale
Standard Deviation 1.61
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Flavor
n=86 Participants
Either a sweet-flavored or a non-flavored cigarillo
Flavor: Sweet flavored vs. non-flavored cigarillos.
|
|---|---|
|
Relative Reinforcing Value of Cigarillo Flavoring
Sweet flavored
|
6.34 trials
Interval 5.98 to 6.7
|
|
Relative Reinforcing Value of Cigarillo Flavoring
Non-flavored
|
3.66 trials
Interval 3.3 to 4.02
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Flavor
n=86 Participants
Either a sweet-flavored or a non-flavored cigarillo
Flavor: Sweet flavored vs. non-flavored cigarillos.
|
|---|---|
|
Absolute Reinforcing Value of Cigarillo Flavoring
Sweet flavored
|
40.88 puffs
Interval 37.74 to 44.03
|
|
Absolute Reinforcing Value of Cigarillo Flavoring
Non-flavored
|
23.12 puffs
Interval 20.25 to 25.98
|
Adverse Events
Flavor
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Flavor
n=86 participants at risk
Either a sweet-flavored or a non-flavored cigarillo
Flavor: Sweet flavored vs. non-flavored cigarillos.
|
|---|---|
|
General disorders
Participant vomited in smoking lab sink after taking cigarillo puffs during Lab visit 2.
|
1.2%
1/86 • Number of events 1 • 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.
|
Additional Information
Janet Audrain-McGovern, Ph.D. Director, Addictions, Department of Psychiatry
Perelman School of Medicine, University of Pennsylvania
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place