Clinical trial NCT03168191: Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 2
Official title: Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Nicotine Dependence
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 20
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study is to examine if inhaled doses of an e-cigarette flavor, alone and in combination with menthol, changes the appeal of e-cigarettes containing low and high doses of nicotine. The hypothesis is that menthol and the other experimental flavor will interact with nicotine dose to improve taste and liking for e-cigarettes.


Eligibility criteria: Inclusion Criteria:

* Ages 18-20 years
* Able to read and write
* Urine cotinine levels of \>250 ng/ml at screening appointment
* Use of e-cigarettes in the past month
* May or may not currently smoke traditional cigarettes

Exclusion Criteria:

* Seeking smoking cessation treatment
* Current/lifetime criteria for dependence on another psychoactive substance -Daily use of alcohol or marijuana or use of any other drugs including cocaine, opiates, stimulants
* Regular use of psychoactive drugs including anxiolytics, antidepressants and other psychostimulants
* Current or past history of psychosis or other psychiatric diagnosis such as major depression
* Any significant current medical condition

Primary outcomes:
measure: Change score in Liking/wanting of the e-cigarette
timeFrame: Baseline (+10 minutes) to end of lab session (+40 minutes)
Secondary outcomes:
measure: Change score in rating of coolness
timeFrame: Baseline (+10 minutes) to end of lab session (+40 minutes)
measure: Change score in rating of harshness/irritation
timeFrame: Baseline (+10 minutes) to end of lab session (+40 minutes)
measure: Change score in rating of sweetness
timeFrame: Baseline (+10 minutes) to end of lab session (+40 minutes)
measure: Change score in rating of sourness
timeFrame: End of lab session (+40 minutes)
measure: Change score in rating of fruitiness
timeFrame: Baseline (+10 minutes) to end of lab session (+40 minutes)
measure: Change score in rating of total sensation
timeFrame: Baseline (+10 minutes) to end of lab session (+40 minutes)
measure: E-cigarette value
timeFrame: Baseline (+10 minutes) to end of lab session (+40 minutes)
measure: Number of puffs
timeFrame: End of ad-lib lab session 4 (+40 minutes)
measure: Change score in Tobacco Craving
timeFrame: Baseline (+10 minutes) to end of lab session (+40 minutes)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: CMHC, Substance Abuse Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Dana Cavallo, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Jackson A, Green B, Erythropel HC, Kong G, Cavallo DA, Eid T, Gueorguieva R, Buta E, O'Malley SS, Krishnan-Sarin S. Influence of menthol and green apple e-liquids containing different nicotine concentrations among youth e-cigarette users. Exp Clin Psychopharmacol. 2021 Aug;29(4):355-365. doi: 10.1037/pha0000368. Epub 2020 Apr 16.