Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 1
NCT ID: NCT02179034
Last Updated: 2020-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
59 participants
INTERVENTIONAL
2014-10-23
2017-06-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
DOUBLE
Study Groups
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Tobacco Flavor
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.
Low Dose Menthol
A low dose of menthol will be added to the tobacco flavor.
High Dose Menthol
A high dose of menthol will be added to the tobacco flavor.
Low Dose Nicotine
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.
Nicotine
Participants will receive no nicotine, low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml)
Low Dose Menthol
A low dose of menthol will be added to the tobacco flavor.
High Dose Menthol
A high dose of menthol will be added to the tobacco flavor.
High Dose Nicotine
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.
Nicotine
Participants will receive no nicotine, low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml)
Low Dose Menthol
A low dose of menthol will be added to the tobacco flavor.
High Dose Menthol
A high dose of menthol will be added to the tobacco flavor.
Interventions
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Nicotine
Participants will receive no nicotine, low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml)
Low Dose Menthol
A low dose of menthol will be added to the tobacco flavor.
High Dose Menthol
A high dose of menthol will be added to the tobacco flavor.
Eligibility Criteria
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Inclusion Criteria
* Able to read and write
* Cigarette smoker
* Use of e-cigarettes in the past 30 days
Exclusion Criteria
* 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
18 Years
20 Years
ALL
Yes
Sponsors
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Yale University
OTHER
Responsible Party
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Principal Investigators
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Dana Cavallo, PhD
Role: STUDY_DIRECTOR
Yale University
Locations
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CMHC
New Haven, Connecticut, United States
Countries
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Other Identifiers
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1307012312
Identifier Type: -
Identifier Source: org_study_id
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