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Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 1

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ClinicalTrials.gov Identifier: NCT02179034
Recruitment Status : Completed
First Posted : July 1, 2014
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Yale University

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.

Condition or disease Intervention/treatment Phase
Nicotine Dependence, Other Tobacco Product Drug: Nicotine Other: Low Dose Menthol Other: High Dose Menthol Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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 1
Actual Study Start Date : October 23, 2014
Actual Primary Completion Date : July 18, 2016
Actual Study Completion Date : June 12, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arm Intervention/treatment
Placebo Comparator: 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.
Other: Low Dose Menthol
A low dose of menthol will be added to the tobacco flavor.

Other: High Dose Menthol
A high dose of menthol will be added to the tobacco flavor.

Active Comparator: 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.
Drug: Nicotine
Participants will receive no nicotine, low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml)

Other: Low Dose Menthol
A low dose of menthol will be added to the tobacco flavor.

Other: High Dose Menthol
A high dose of menthol will be added to the tobacco flavor.

Active Comparator: 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.
Drug: Nicotine
Participants will receive no nicotine, low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml)

Other: Low Dose Menthol
A low dose of menthol will be added to the tobacco flavor.

Other: High Dose Menthol
A high dose of menthol will be added to the tobacco flavor.




Primary Outcome Measures :
  1. Liking/effect score of the e-cigarette [ Time Frame: 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 Outcome Measures :
  1. Maximum value of money at which the e-cigarette is chosen over money [ Time Frame: 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.

  2. Change scores from baseline in Nicotine Withdrawal [ Time Frame: 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

  3. Change scores from baseline in Tobacco Craving [ Time Frame: 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



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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
  • 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

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): NCT02179034


Locations
United States, Connecticut
CMHC
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
Study Director: Dana Cavallo, PhD Yale University

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02179034     History of Changes
Other Study ID Numbers: 1307012312
First Posted: July 1, 2014    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017

Keywords provided by Yale University:
tobacco
electronic cigarettes
menthol
flavors

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Menthol
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