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Completed

NCT Number: NCT02179034

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

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.

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Key information

Conditions

Nicotine Dependence, Other Tobacco Product Behavior Chemically-Induced Disorders Mental Disorders Smoking Substance-Related Disorders Tobacco Use Disorder Vaping

Age range

18 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CMHC

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
  • 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

Treatment and study plan

nicotine

Drug

Participants will receive no nicotine, low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml)

Low Dose Menthol

Other

A low dose of menthol will be added to the tobacco flavor.

High Dose Menthol

Other

A high dose of menthol will be added to the tobacco flavor.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jul 1, 2014
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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