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Completed

NCT Number: NCT03168191

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

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.

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Key information

Conditions

Nicotine Dependence Chemically-Induced Disorders Mental Disorders Substance-Related Disorders Tobacco Use Disorder

Age range

18 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CMHC, Substance Abuse Center

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nicotine

Drug

Participants will receive low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml)

Experimental Flavor

Other

Experimental fruit flavored e-cigarette for lab session

Menthol Flavor

Other

Menthol flavored e-cigarette for lab session

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
May 30, 2017
Registry last updated
May 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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