Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 2
- Conditions
- Nicotine Dependence
- Interventions
- Registration Number
- NCT03168191
- Lead Sponsor
- Yale University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Menthol Flavor Menthol Flavor In this arm, subjects will receive a menthol flavor. Participants will be randomly assigned to low or high dose of nicotine. E-cigarette flavor Experimental Flavor In this arm, subjects will receive an experimental flavor. Participants will be randomly assigned to low or high dose of nicotine. E-cigarette flavor Nicotine In this arm, subjects will receive an experimental flavor. Participants will be randomly assigned to low or high dose of nicotine. Menthol Flavor Nicotine In this arm, subjects will receive a menthol flavor. Participants will be randomly assigned to low or high dose of nicotine. No Flavor Nicotine In this arm, subjects will receive no flavor. Participants will be randomly assigned to low or high dose of nicotine.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change score in rating of coolness Baseline (+10 minutes) to end of lab session (+40 minutes) gMLS rating of e-cigarette coolness
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 rating of total sensation Baseline (+10 minutes) to end of lab session (+40 minutes) gMLS rating of e-cigarette total sensation
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 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
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
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 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
Trial Locations
- Locations (1)
CMHC, Substance Abuse Center
🇺🇸New Haven, Connecticut, United States