Effects of E-cigarette Flavors on Youth TCORS 2.0

Effects of E-cigarette Flavors on Youth

This study is an examination of the influence of sweet and cooling flavors on the appeal and abuse potential of nicotine-containing e-cigarettes among susceptible youth.

Study Overview

• Status: Completed
• Conditions: Nicotine Use Disorder
• Intervention / Treatment: Drug: Nicotine; Drug: Flavoring Agents

Detailed Description

Researchers will examine the influence of sweet and cooling flavors on the appeal and abuse potential of nicotine-containing e-cigarettes among susceptible youth. Participants will rate the flavor intensity, coolness, sweetness, and irritation experienced using validated rating scales. Forty youth (18-20 years of age) who have experience with e-cigarettes and will participate in 1 laboratory session. They will receive 1 nicotine concentrations (36mg/ml nicotine salt) during the session; during the session they will be exposed, in random order, to sweet (watermelon) and sweet-cooling (watermelon-menthol) flavors combined with the assigned session nicotine concentration.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Danielle Davis, PhD; Phone Number: 203-974-7607; Email: danielle.davis@yale.edu
• Study Contact Backup: Name: Wei Li; Phone Number: (203) 974-7594; Email: wei.vanness.li@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • CMHC, Substance Abuse Center
      • Contact: Asti Jackson, PhD; Phone Number: 203-974-7598; Email: asti.jackson@yale.edu
      • Contact: Thomas Liss; Phone Number: 203-361-4267; Email: thomas.liss@yale.edu
      • Principal Investigator: Suchitra Krishnan-Sarin, Ph.D.

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Ages 18-20 years
• Able to read and write
• Used e-cigs at least 10 times in lifetime
• Used e-cigs in past 30 days

Exclusion Criteria:

• Current use of non-prescription substances besides nicotine, marijuana, alcohol
• Any significant current medical or psychiatric condition
• Known hypersensitivity to propylene glycol
• Pregnant or lactating females
• Uncontrolled asthma
• Nut/e-liquid flavorant allergy
• current marijuana (tetrahydrocannabinol) vaping + E-cigarette or vaping use Associated Lung Injury (EVALI) symptoms

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sweet non-menthol, nicotine 36mg/ml; Sweet flavor non-menthol (Watermelon) with 36mg/ml Nicotine	Drug: Nicotine; Nicotine level (0, 3, or 12 mg); Drug: Flavoring Agents; Flavor of e-liquid - sweet or tobacco
Experimental: Sweet menthol, nicotine 36mg/ml; Sweet flavor with menthol (Watermelon-menthol) with 36mg/ml Nicotine	Drug: Nicotine; Nicotine level (0, 3, or 12 mg); Drug: Flavoring Agents; Flavor of e-liquid - sweet or tobacco

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liking: Difference score in liking/wanting of each e-cigarette condition	The Labeled Hedonic Scale will be used to ask about liking and wanting of the e-cigarette (one item Visual Analog Scale with ratings ranging from "most disliked sensation imaginable" to "most liked sensation imaginable" with higher values indicating greater liking).	Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40)
Reinforcing Efficacy: Difference score in drug effects of each e-cigarette condition	Difference between e-cigarette effects for each e-cigarette condition as measured by the computerized version of the Drug Effects Questionnaire (DEQ). Participants will self-report their responses using a computer mouse to indicate where on the scale response falls. A modified version of the Drug Effects Questionnaire (DEQ) will be used in which participants rate acute responses to the e-cigarette on a 0-100mm scale from "not at all" (0mm) to "extremely" (100mm).	Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40)
Craving: change in craving score for e-cigarette	Difference from baseline in craving for each e-cigarette condition will be measured by the Generalized Labeled Magnitude Scale (gLMS). Participants will self-report their craving for e-cigarettes using a computer mouse to indicate where on the scale response falls. The Generalized Labeled Magnitude Scales (gLMS) are category ratio scales with seven semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically as per empirically determined semantic magnitudes on a 0-100 scale (strongest imaginable at the 100 end).	At baseline (+0 minutes), Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40)
Irritation/Harshness: Difference score in irritation of harshness of each e-cigarette condition	Difference in irritation at each e-cigarette condition as measured by the computerized Generalized Labeled Magnitude Scale (gLMS). Participants will self-report their responses using a computer mouse to indicate where on the scale response falls. The Generalized Labeled Magnitude Scales (gLMS) are category ratio scales with seven semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically as per empirically determined semantic magnitudes on a 0-100 scale (strongest imaginable at the 100 end).	Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Aim: Change in e-cigarette use 1 month after study procedures	Difference in e-cigarette use (number of days/month) after e-cigarette procedures	+1 month after lab session completion

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Suchitra Krishnan-Sarin, PhD, Yale University

Publications and helpful links

General Publications

• Lim J, Wood A, Green BG. Derivation and evaluation of a labeled hedonic scale. Chem Senses. 2009 Nov;34(9):739-51. doi: 10.1093/chemse/bjp054.

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2022
• Primary Completion (Actual): June 16, 2023
• Study Completion (Actual): July 20, 2023

Study Registration Dates

• First Submitted: August 13, 2018
• First Submitted That Met QC Criteria: August 13, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

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; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 2000023077-1; 2U54DA036151-06 (U.S. NIH Grant/Contract)

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