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.

Study Overview

• Status: Completed
• Conditions: Nicotine Dependence
• Intervention / Treatment: Drug: Nicotine; Other: Experimental Flavor; Other: Menthol Flavor

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • CMHC, Substance Abuse Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 20 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: E-cigarette flavor; In this arm, subjects will receive an experimental flavor. Participants will be randomly assigned to low or high dose of nicotine.	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
Experimental: Menthol Flavor; In this arm, subjects will receive a menthol flavor. Participants will be randomly assigned to low or high dose of nicotine.	Drug: Nicotine; Participants will receive low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml); Other: Menthol Flavor; Menthol flavored e-cigarette for lab session
Placebo Comparator: No Flavor; In this arm, subjects will receive no flavor. Participants will be randomly assigned to low or high dose of nicotine.	Drug: Nicotine; Participants will receive low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change score in rating of coolness	gMLS rating of e-cigarette coolness	Baseline (+10 minutes) to end of lab session (+40 minutes)
Change score in rating of harshness/irritation	gMLS rating of e-cigarette harshness/irritation	Baseline (+10 minutes) to end of lab session (+40 minutes)
Change score in rating of sweetness	gMLS rating of e-cigarette sweetness	Baseline (+10 minutes) to end of lab session (+40 minutes)
Change score in rating of sourness	gMLS rating of e-cigarette sourness	End of lab session (+40 minutes)
Change score in rating of fruitiness	gMLS rating of e-cigarette fruitiness	Baseline (+10 minutes) to end of lab session (+40 minutes)
Change score in rating of total sensation	gMLS rating of e-cigarette total sensation	Baseline (+10 minutes) to end of lab session (+40 minutes)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Study Director: Dana Cavallo, Ph.D., Yale University

Publications and helpful links

General Publications

• Jackson A, Green B, Erythropel HC, Kong G, Cavallo DA, Eid T, Gueorguieva R, Buta E, O'Malley SS, Krishnan-Sarin S. Influence of menthol and green apple e-liquids containing different nicotine concentrations among youth e-cigarette users. Exp Clin Psychopharmacol. 2021 Aug;29(4):355-365. doi: 10.1037/pha0000368. Epub 2020 Apr 16.

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2017
• Primary Completion (Actual): August 22, 2018
• Study Completion (Actual): February 25, 2019

Study Registration Dates

• First Submitted: April 27, 2017
• First Submitted That Met QC Criteria: May 24, 2017
• First Posted (Actual): May 30, 2017

Study Record Updates

• Last Update Posted (Actual): May 4, 2020
• Last Update Submitted That Met QC Criteria: April 30, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Dermatologic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Antipruritics; Nicotine; Menthol
• Other Study ID Numbers: 1307012312-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No