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

Nicotine Dependence, Other Tobacco Product Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02179034
• Other study ID #: 1307012312
• Status: Completed
• Phase: Phase 1
• Start date: October 23, 2014
• Est. completion date: June 12, 2017

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: June 12, 2017
• Est. primary completion date: July 18, 2016
• 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

• 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

Related Conditions & MeSH terms

• Nicotine Dependence, Other Tobacco Product
• Tobacco Use Disorder

Intervention

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

Locations

Country	Name	City	State
United States	CMHC	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	Liking/effect score of the e-cigarette	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.	Every 30 min for 120 min during lab session
Secondary	Maximum value of money at which the e-cigarette is chosen over money	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.	Every 30 min for 120 min during lab session
Secondary	Change scores from baseline in Nicotine Withdrawal	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	Every 30 min for 120 min during lab session
Secondary	Change scores from baseline 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	Every 30 min for 120 min during lab session