Phase 1
N=16
The Interaction of Flavor With Nicotine Form in Adult Smokers
Nicotine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT04262817 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Changes in Liking of E-cigarette Overall — 14.2; 5.3; 11.9; 2.2 score on a scale — p=0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Nicotine form (Drug); E-cigarette experimental flavor (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Liking of E-cigarette Overall |
14.2; 5.3; 11.9; 2.2 | 0.01 sig |
| PRIMARY Changes in Liking of E-cigarette Flavor |
4.1; 0.0; 6.3; 2.2 | 0.38 |
| SECONDARY gLMS: Sweetness |
2.1; 2.0; 2.1; 2.0 | 0.39 |
| SECONDARY gLMS: Coolness |
1.9; 1.7; 2.0; 1.6 | 0.43 |
| SECONDARY gLMS: Irritation |
2.1; 2.6; 2.1; 2.5 | 0.05 |
| SECONDARY Number of Puffs |
2.1; 1.7; 2.1; 1.8 | 0.01 sig |
Summary
This study seeks to elucidate the impact of e-cigarette flavor on subjective effects and nicotine exposure from e-cigarettes containing different forms of nicotine.
Eligibility Criteria
Inclusion Criteria
- At least 21 years old, able to read and write, use of combustible
Exclusion Criteria
-
Data sourced from ClinicalTrials.gov (NCT04262817). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.