Clinical trial NCT03634839: Effects of E-cigarette Flavors on Youth TCORS 2.0
Official title: Effects of E-cigarette Flavors on Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Nicotine Use Disorder
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2018-08-17
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 20
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.

Detailed description: Researchers will examine the influence of sweet and cooling flavors on the appeal and abuse potential of nicotine-containing e-cigarettes among susceptible youth. Participants will rate the flavor intensity, coolness, sweetness, and irritation experienced using validated rating scales. Forty youth (18-20 years of age) who have experience with e-cigarettes and will participate in 1 laboratory session. They will receive 1 nicotine concentrations (36mg/ml nicotine salt) during the session; during the session they will be exposed, in random order, to sweet (watermelon) and sweet-cooling (watermelon-menthol) flavors combined with the assigned session nicotine concentration.

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

Primary outcomes:
measure: Liking: Difference Score in Liking/Wanting of Each E-cigarette Condition
timeFrame: Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40)
measure: Reinforcing Efficacy: Difference Score in Drug Effects of Each E-cigarette Condition
timeFrame: Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40)
measure: Craving: Change in Craving Score for E-cigarette
timeFrame: At baseline (+0 minutes), Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40)
measure: Irritation/Harshness: Difference Score in Irritation of Harshness of Each E-cigarette Condition
timeFrame: Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40)
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: CMHC, Substance Abuse Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Suchitra Krishnan-Sarin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lim J, Wood A, Green BG. Derivation and evaluation of a labeled hedonic scale. Chem Senses. 2009 Nov;34(9):739-51. doi: 10.1093/chemse/bjp054.