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Effects of E-cigarette Flavors on Youth TCORS 2.0

Primary Purpose

Nicotine Use Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Flavoring Agents
Nicotine
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Nicotine Use Disorder

Eligibility Criteria

18 Years - 20 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ages 16-20 years
  • Able to read and write
  • Tried e-cigs at least once but no more than 10 times in lifetime
  • No past month use of e-cigarettes

Exclusion Criteria:

  • Daily use of other drugs including prescribed psychoactive drugs
  • Any significant current medical or psychiatric condition
  • Known hypersensitivity to propylene glycol
  • Pregnant or lactating females

Sites / Locations

  • CMHC, Substance Abuse Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sweet non-menthol, nicotine 36mg/ml

Sweet menthol, nicotine 36mg/ml

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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).
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).
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).

Secondary Outcome Measures

Full Information

First Posted
August 13, 2018
Last Updated
October 12, 2023
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03634839
Brief Title
Effects of E-cigarette Flavors on Youth TCORS 2.0
Official Title
Effects of E-cigarette Flavors on Youth
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
June 16, 2023 (Actual)
Study Completion Date
July 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Use Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Flavor and nicotine concentration is blinded to participant. Research staff and investigators are blinded to flavor order administer to participants.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sweet non-menthol, nicotine 36mg/ml
Arm Type
Experimental
Arm Description
Sweet flavor non-menthol (Watermelon) with 36mg/ml Nicotine
Arm Title
Sweet menthol, nicotine 36mg/ml
Arm Type
Experimental
Arm Description
Sweet flavor with menthol (Watermelon-menthol) with 36mg/ml Nicotine
Intervention Type
Drug
Intervention Name(s)
Flavoring Agents
Intervention Description
Flavor of e-liquid - sweet or tobacco
Intervention Type
Drug
Intervention Name(s)
Nicotine
Intervention Description
Nicotine level (0, 3, or 12 mg)
Primary Outcome Measure Information:
Title
Liking: Difference score in liking/wanting of each e-cigarette condition
Description
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).
Time Frame
Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40)
Title
Reinforcing Efficacy: Difference score in drug effects of each e-cigarette condition
Description
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).
Time Frame
Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40)
Title
Craving: change in craving score for e-cigarette
Description
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).
Time Frame
At baseline (+0 minutes), Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40)
Title
Irritation/Harshness: Difference score in irritation of harshness of each e-cigarette condition
Description
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).
Time Frame
Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40)
Other Pre-specified Outcome Measures:
Title
Exploratory Aim: Change in e-cigarette use 1 month after study procedures
Description
Difference in e-cigarette use (number of days/month) after e-cigarette procedures
Time Frame
+1 month after lab session completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suchitra Krishnan-Sarin, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CMHC, Substance Abuse Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19833660
Citation
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.
Results Reference
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Effects of E-cigarette Flavors on Youth TCORS 2.0

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