Back to resultsFlavors and E-cigarette Effects in Adolescent Smokers- STUDY 1
Primary Purpose
Nicotine Dependence, Other Tobacco Product
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nicotine
Low Dose Menthol
High Dose Menthol
Sponsored by
About this trial
This is an interventional other trial for Nicotine Dependence, Other Tobacco Product focused on measuring tobacco, electronic cigarettes, menthol, flavors
Eligibility Criteria
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
Sites / Locations
- CMHC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Tobacco Flavor
Low Dose Nicotine
High Dose Nicotine
Arm Description
In this arm, subjects will receive tobacco flavor- without nicotine (placebo). Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose.
In this arm, subjects will receive a low dose of nicotine (6 mg/ml) added to the tobacco flavor. Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose.
In this arm, subjects will receive a high dose of nicotine (12 mg/ml) added to the tobacco flavor. Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose.
Outcomes
Primary Outcome Measures
Liking/effect score of the e-cigarette
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 Outcome Measures
Maximum value of money at which the e-cigarette is chosen over money
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02179034
Brief Title
Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 1
Official Title
Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 1
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
October 23, 2014 (Actual)
Primary Completion Date
July 18, 2016 (Actual)
Study Completion Date
June 12, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence, Other Tobacco Product
Keywords
tobacco, electronic cigarettes, menthol, flavors
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tobacco Flavor
Arm Type
Placebo Comparator
Arm Description
In this arm, subjects will receive tobacco flavor- without nicotine (placebo). Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose.
Arm Title
Low Dose Nicotine
Arm Type
Active Comparator
Arm Description
In this arm, subjects will receive a low dose of nicotine (6 mg/ml) added to the tobacco flavor. Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose.
Arm Title
High Dose Nicotine
Arm Type
Active Comparator
Arm Description
In this arm, subjects will receive a high dose of nicotine (12 mg/ml) added to the tobacco flavor. Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose.
Intervention Type
Drug
Intervention Name(s)
Nicotine
Intervention Description
Participants will receive no nicotine, low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml)
Intervention Type
Other
Intervention Name(s)
Low Dose Menthol
Intervention Description
A low dose of menthol will be added to the tobacco flavor.
Intervention Type
Other
Intervention Name(s)
High Dose Menthol
Intervention Description
A high dose of menthol will be added to the tobacco flavor.
Primary Outcome Measure Information:
Title
Liking/effect score of the e-cigarette
Description
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.
Time Frame
Every 30 min for 120 min during lab session
Secondary Outcome Measure Information:
Title
Maximum value of money at which the e-cigarette is chosen over money
Description
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.
Time Frame
Every 30 min for 120 min during lab session
Title
Change scores from baseline in Nicotine Withdrawal
Description
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
Time Frame
Every 30 min for 120 min during lab session
Title
Change scores from baseline in Tobacco Craving
Description
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
Time Frame
Every 30 min for 120 min during lab session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana Cavallo, PhD
Organizational Affiliation
Yale University
Official's Role
Study Director
Facility Information:
Facility Name
CMHC
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 1
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