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

Nicotine Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03168191
• Other study ID #: 1307012312-2
• Status: Completed
• Phase: Phase 1
• Start date: May 2, 2017
• Est. completion date: February 25, 2019

Study information

• Verified date: April 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 25, 2019
• Est. primary completion date: August 22, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

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
• Menthol Flavor
Menthol flavored e-cigarette for lab session

Locations

Country	Name	City	State
United States	CMHC, Substance Abuse Center	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change score in Liking/wanting of the e-cigarette	The Drug Effects Questionnaire (Soria et al) will be used to ask about liking and wanting during the lab session	Baseline (+10 minutes) to end of lab session (+40 minutes)
Secondary	Change score in rating of coolness	gMLS rating of e-cigarette coolness	Baseline (+10 minutes) to end of lab session (+40 minutes)
Secondary	Change score in rating of harshness/irritation	gMLS rating of e-cigarette harshness/irritation	Baseline (+10 minutes) to end of lab session (+40 minutes)
Secondary	Change score in rating of sweetness	gMLS rating of e-cigarette sweetness	Baseline (+10 minutes) to end of lab session (+40 minutes)
Secondary	Change score in rating of sourness	gMLS rating of e-cigarette sourness	End of lab session (+40 minutes)
Secondary	Change score in rating of fruitiness	gMLS rating of e-cigarette fruitiness	Baseline (+10 minutes) to end of lab session (+40 minutes)
Secondary	Change score in rating of total sensation	gMLS rating of e-cigarette total sensation	Baseline (+10 minutes) to end of lab session (+40 minutes)
Secondary	E-cigarette value	Value of e-cigarette as determined by the Multiple Choice Questionnaire (MCP) task	Baseline (+10 minutes) to end of lab session (+40 minutes)
Secondary	Number of puffs	Number of puffs taken at the end of the ad-lib vaping period	End of ad-lib lab session 4 (+40 minutes)
Secondary	Change score in Tobacco Craving	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	Baseline (+10 minutes) to end of lab session (+40 minutes)