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

Phase 1

Completed

• Conditions: Nicotine Dependence, Other Tobacco Product
• Interventions: Drug: Nicotine; Other: Low Dose Menthol; Other: High Dose Menthol

• Registration Number: NCT02179034
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-24
• Study First Submitted QC: 2014-06-27
• Study First Posted: 2014-07-01
• Study Start: 2014-10-23
• Primary Completion: 2016-07-18
• Study Completion: 2017-06-12
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-30
• Last Update Posted: 2020-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• Ages 18-20 years
• Able to read and write
• Cigarette smoker
• Use of e-cigarettes in the past 30 days

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low Dose Nicotine	High Dose Menthol	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.
Tobacco Flavor	High Dose Menthol	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.
Low Dose Nicotine	Low Dose Menthol	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.
Tobacco Flavor	Low Dose Menthol	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.
High Dose Nicotine	High Dose Menthol	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.
High Dose Nicotine	Low Dose Menthol	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.
Low Dose Nicotine	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.
High Dose Nicotine	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.

Primary Outcome Measures

Name	Time	Method
Liking/effect score of the e-cigarette	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

Name	Time	Method
Change scores from baseline in Nicotine Withdrawal	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
Maximum value of money at which the e-cigarette is chosen over money	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.
Change scores from baseline in Tobacco Craving	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

Trial Locations

Locations (1)

CMHC; 🇺🇸 New Haven, Connecticut, United States