Nicotine Dependence, Other Tobacco Product
Conditions
Keywords
tobacco, electronic cigarettes, menthol, flavors
Brief summary
This study is to examine if inhaled doses of menthol that produce low and high cooling effects change the appeal of e-cigarettes containing low and high doses of nicotine in adolescent smokers. The hypothesis is that the combination of nicotine and menthol, when compared with menthol or nicotine alone, will result in greater increase in liking of an e-cigarette and greater reduction in nicotine withdrawal.
Interventions
DRUGNicotine
Participants will receive no nicotine, low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml)
OTHERLow Dose Menthol
A low dose of menthol will be added to the tobacco flavor.
OTHERHigh Dose Menthol
A high dose of menthol will be added to the tobacco flavor.
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 * Cigarette smoker * Use of e-cigarettes in the past 30 days
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 |
|---|---|---|
| Liking/effect score of the e-cigarette | Every 30 min for 120 min during lab session | The Drug Effects Questionnaire (Soria et al) will be used to ask about participants' liking/effect of the e-cigarettes smoked during the 4 bouts of e-cigarette puffing during the lab session to determine which menthol dose is most preferred. A linear mixed-effects regression model wil be used with nicotine group (none, low, high) as between-subject factor, and menthol dose (none, low dose, high dose) as within-subject factor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum value of money at which the e-cigarette is chosen over money | Every 30 min for 120 min during lab session | E-cigarette value will be determined using the Multiple Choice Procedure (Griffiths et al, 1993) to determine the reinforcing value of the e-cigarette. The MCP involves sampling the e-cigarette and then making a discrete choice between the e-cigarette or a series of monetary values. |
| Change scores from baseline in Nicotine Withdrawal | Every 30 min for 120 min during lab session | The Minnesota Nicotine Withdrawal Scale (Hughes et al,1986) will be used to assess the magnitude of change in nicotine withdrawal symptoms during the lab session |
| Change scores from baseline in Tobacco Craving | Every 30 min for 120 min during lab session | 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 |
Countries
United States
Outcome results
None listed