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Phase 1 N=42 Randomized Triple-blind Other

Effects of E-cigarette Flavors on Youth TCORS 2.0

Nicotine Use Disorder

Bottom Line

View on ClinicalTrials.gov: NCT03634839 ↗
Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Liking: Difference Score in Liking/Wanting of Each E-cigarette Condition — 1.268; -3.916 score on a scale — p=0.053

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
Flavoring Agents (Drug); Nicotine (Drug)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Yale University
Primary completion
Jun 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Liking: Difference Score in Liking/Wanting of Each E-cigarette Condition		 1.268; -3.916 0.053
PRIMARY
Reinforcing Efficacy: Difference Score in Drug Effects of Each E-cigarette Condition		 37.06; 35.18 0.187
PRIMARY
Craving: Change in Craving Score for E-cigarette		 2.72; 2.43 0.135
PRIMARY
Irritation/Harshness: Difference Score in Irritation of Harshness of Each E-cigarette Condition		 20.92; 22.86 0.210

Summary

This study is an examination of the influence of sweet and cooling flavors on the appeal and abuse potential of nicotine-containing e-cigarettes among susceptible youth.

Eligibility Criteria

Inclusion Criteria

  • Ages 18-20 years
  • Able to read and write
  • Used e-cigs at least 10 times in lifetime
  • Used e-cigs in past 30 days

Exclusion Criteria

  • Current use of non-prescription substances besides nicotine, marijuana, alcohol
  • Any significant current medical or psychiatric condition
  • Known hypersensitivity to propylene glycol
  • Pregnant or lactating females
  • Uncontrolled asthma
  • Nut/e-liquid flavorant allergy
  • current marijuana (tetrahydrocannabinol) vaping + E-cigarette or vaping use Associated Lung Injury (EVALI) symptoms
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03634839). 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.

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