Last reviewed · How we verify

NCT05092919: FLAV

The Effect of Sweet Flavoring on the Rewarding and Reinforcing Value of Cigarillo Use Among Young Adults

Completed EARLY_PHASE1 Results posted Last updated 17 May 2024
What this trial tests

EARLY_PHASE1 trial testing Flavor in Tobacco Use in 95 participants. Completed in 31 May 2023.

Timeline
14 September 2021
Primary endpoint
28 February 2023
31 May 2023

Quick facts

Lead sponsorUniversity of Pennsylvania
PhaseEARLY_PHASE1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposebasic science
Enrollment95
Start date14 September 2021
Primary completion28 February 2023
Estimated completion31 May 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Pennsylvania

Who can join

Adults 18 to 24, any sex, with Tobacco Use or Cigar Smoking. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Subjective Rewarding Value of Cigarillo Flavoring Primary · 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.

Citrus "Jazz"
GroupValue95% CI
Flavor4.03± 1.47
Cream
GroupValue95% CI
Flavor3.63± 1.42
Non-flavored
GroupValue95% CI
Flavor3.30± 1.61
Relative Reinforcing Value of Cigarillo Flavoring Primary · 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

Sweet flavored
GroupValue95% CI
Flavor6.345.98 – 6.70
Non-flavored
GroupValue95% CI
Flavor3.663.30 – 4.02
Absolute Reinforcing Value of Cigarillo Flavoring Primary · 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.

Sweet flavored
GroupValue95% CI
Flavor40.8837.74 – 44.03
Non-flavored
GroupValue95% CI
Flavor23.1220.25 – 25.98

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Flavor
Serious: 0/86 (0%)
Deaths: 0/86
Other adverse events (1 terms — click to expand)

ReactionSystemFlavor
Participant vomited in smoking lab sink after taking cigarillo puffs during Lab visit 2.General disorders

Data from ClinicalTrials.gov NCT05092919 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Effect of sweet flavouring on the rewarding and reinforcing value of cigarillo use among young adults.
    Audrain-McGovern J, Manikandan D, Koita F, Klapec O, et al · · 2025 · cited 3× · PMID 38050181 · DOI 10.1136/tc-2023-058307
  2. The interacting effects of depression symptoms and sweet flavoring on the rewarding and reinforcing value of cigarillo use among young adults.
    Audrain-McGovern J, Klapec O, Koita F, Manikandan D, et al · · 2024 · PMID 38646014 · DOI 10.1016/j.dadr.2024.100234

Verify or expand the search:

Other trials of Flavor

Trials testing the same drug.

Other recruiting trials for Tobacco Use

Currently open trials in the same condition.

Other University of Pennsylvania trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05092919.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing