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Trial record 8 of 19 for:    E-cigarettes youth

Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 2

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ClinicalTrials.gov Identifier: NCT03168191
Recruitment Status : Completed
First Posted : May 30, 2017
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Drug: Nicotine Other: Experimental Flavor Other: Menthol Flavor Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Other
Official Title: Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 2
Actual Study Start Date : May 2, 2017
Actual Primary Completion Date : August 22, 2018
Actual Study Completion Date : February 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes
Drug Information available for: Menthol

Arm Intervention/treatment
Experimental: E-cigarette flavor
In this arm, subjects will receive an experimental flavor. Participants will be randomly assigned to low or high dose of nicotine.
Drug: Nicotine
Participants will receive low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml)

Other: Experimental Flavor
Experimental fruit flavored e-cigarette for lab session

Experimental: Menthol Flavor
In this arm, subjects will receive a menthol flavor. Participants will be randomly assigned to low or high dose of nicotine.
Drug: Nicotine
Participants will receive low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml)

Other: Menthol Flavor
Menthol flavored e-cigarette for lab session

Placebo Comparator: No Flavor
In this arm, subjects will receive no flavor. Participants will be randomly assigned to low or high dose of nicotine.
Drug: Nicotine
Participants will receive low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml)




Primary Outcome Measures :
  1. Change score in Liking/wanting of the e-cigarette [ Time Frame: 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 :
  1. Change score in rating of coolness [ Time Frame: Baseline (+10 minutes) to end of lab session (+40 minutes) ]
    gMLS rating of e-cigarette coolness

  2. Change score in rating of harshness/irritation [ Time Frame: Baseline (+10 minutes) to end of lab session (+40 minutes) ]
    gMLS rating of e-cigarette harshness/irritation

  3. Change score in rating of sweetness [ Time Frame: Baseline (+10 minutes) to end of lab session (+40 minutes) ]
    gMLS rating of e-cigarette sweetness

  4. Change score in rating of sourness [ Time Frame: End of lab session (+40 minutes) ]
    gMLS rating of e-cigarette sourness

  5. Change score in rating of fruitiness [ Time Frame: Baseline (+10 minutes) to end of lab session (+40 minutes) ]
    gMLS rating of e-cigarette fruitiness

  6. Change score in rating of total sensation [ Time Frame: Baseline (+10 minutes) to end of lab session (+40 minutes) ]
    gMLS rating of e-cigarette total sensation

  7. E-cigarette value [ Time Frame: Baseline (+10 minutes) to end of lab session (+40 minutes) ]
    Value of e-cigarette as determined by the Multiple Choice Questionnaire (MCP) task

  8. Number of puffs [ Time Frame: End of ad-lib lab session 4 (+40 minutes) ]
    Number of puffs taken at the end of the ad-lib vaping period

  9. Change score in Tobacco Craving [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 20 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03168191


Locations
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United States, Connecticut
CMHC, Substance Abuse Center
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
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Study Director: Dana Cavallo, Ph.D. Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03168191     History of Changes
Other Study ID Numbers: 1307012312-2
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Menthol
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents