Effects of E-cigarette Flavors on Youth TCORS 2.0

NCT03634839 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: 2000023077-12U54DA036151-06
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nicotine Use Disorder

Outcome Measures

Primary Outcomes (4)

• 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). Specific scale semantic structure and corresponding values: most disliked imaginable=-100, dislike extremely=-62.9, dislike very much=-41.6, dislike moderately=-17.6, dislike slightly=-5.9, neutral=0, like slightly=6.3, like moderately=17.8, like very much=44.4, like extremely=65.7, most liked imaginable=100.

  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). Higher values indicate stronger reinforcing efficacy (i.e., wanting/liking effects).

  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)

Study Arms (2)

Sweet non-menthol, nicotine 36mg/ml

EXPERIMENTAL

Sweet flavor non-menthol (Watermelon) with 36mg/ml Nicotine

Drug: Flavoring Agents; Drug: Nicotine

Sweet menthol, nicotine 36mg/ml

EXPERIMENTAL

Sweet flavor with menthol (Watermelon-menthol) with 36mg/ml Nicotine

Drug: Flavoring Agents; Drug: Nicotine

Interventions

Flavoring Agents DRUG

Flavor of e-liquid - sweet or tobacco

Also known as: Cooling flavor

Sweet menthol, nicotine 36mg/ml; Sweet non-menthol, nicotine 36mg/ml

Nicotine DRUG

Nicotine level (36 mg/ml)

Also known as: Nicotine concentration

Sweet menthol, nicotine 36mg/ml; Sweet non-menthol, nicotine 36mg/ml

Eligibility Criteria

• Age: 18 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

CMHC, Substance Abuse Center

New Haven, Connecticut, 06519, United States

Location

Related Publications (2)

• 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.

  PMID: 19833660 BACKGROUND

• Li W, Davis DR, Wu R, Gueorguieva R, Green BG, Krishnan-Sarin S. The effect of "ice" components in sweet-flavored nicotine-containing e-liquids among young adult e-cigarette users. Exp Clin Psychopharmacol. 2025 Oct;33(5):477-482. doi: 10.1037/pha0000786. Epub 2025 Jun 9.

  PMID: 40489161 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Flavoring Agents; Nicotine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pharmaceutic Aids; Pharmaceutical Preparations; Food Additives; Food Ingredients; Specialty Uses of Chemicals; Chemical Actions and Uses; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Suchitra Krishnan-Sarin
• Organization: Yale University

suchitra.krishnan-sarin@yale.edu

(203)974-7595

Study Officials

• Suchitra Krishnan-Sarin, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Flavor and nicotine concentration is blinded to participant. Research staff and investigators are blinded to flavor order administer to participants.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 17, 2018
• Study Start: November 7, 2022
• Primary Completion: June 16, 2023
• Study Completion: July 20, 2023
• Last Updated: August 9, 2024
• Results First Posted: August 9, 2024

Record last verified: 2024-07

Locations

US (1)