Nicotine Dependence
Conditions
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.
Interventions
DRUGNicotine
Participants will receive low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml)
OTHERExperimental Flavor
Experimental fruit flavored e-cigarette for lab session
OTHERMenthol Flavor
Menthol flavored e-cigarette for lab session
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 20 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change score in Liking/wanting of the e-cigarette | Baseline (+10 minutes) to end of lab session (+40 minutes) | The Drug Effects Questionnaire (Soria et al) will be used to ask about liking and wanting during the lab session |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change score in rating of harshness/irritation | Baseline (+10 minutes) to end of lab session (+40 minutes) | gMLS rating of e-cigarette harshness/irritation |
| Change score in rating of sweetness | Baseline (+10 minutes) to end of lab session (+40 minutes) | gMLS rating of e-cigarette sweetness |
| Change score in rating of sourness | End of lab session (+40 minutes) | gMLS rating of e-cigarette sourness |
| Change score in rating of fruitiness | Baseline (+10 minutes) to end of lab session (+40 minutes) | gMLS rating of e-cigarette fruitiness |
| Change score in rating of coolness | Baseline (+10 minutes) to end of lab session (+40 minutes) | gMLS rating of e-cigarette coolness |
| E-cigarette value | Baseline (+10 minutes) to end of lab session (+40 minutes) | Value of e-cigarette as determined by the Multiple Choice Questionnaire (MCP) task |
| Number of puffs | End of ad-lib lab session 4 (+40 minutes) | Number of puffs taken at the end of the ad-lib vaping period |
| Change score in Tobacco Craving | Baseline (+10 minutes) to end of lab session (+40 minutes) | The Brief Questionnaire on Smoking Urges (Tiffany & Drobes,1991) will be used to assess the magnitude of change in tobacco craving during the lab session |
| Change score in rating of total sensation | Baseline (+10 minutes) to end of lab session (+40 minutes) | gMLS rating of e-cigarette total sensation |
Countries
United States
Outcome results
None listed