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Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 2

Primary Purpose

Nicotine Dependence

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

About this trial

This is an interventional other trial for Nicotine Dependence

Eligibility Criteria

18 Years - 20 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CMHC, Substance Abuse Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

E-cigarette flavor

Menthol Flavor

No Flavor

Arm Description

In this arm, subjects will receive an experimental flavor. Participants will be randomly assigned to low or high dose of nicotine.

In this arm, subjects will receive a menthol flavor. Participants will be randomly assigned to low or high dose of nicotine.

In this arm, subjects will receive no flavor. Participants will be randomly assigned to low or high dose of nicotine.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change score in rating of coolness
gMLS rating of e-cigarette coolness
Change score in rating of harshness/irritation
gMLS rating of e-cigarette harshness/irritation
Change score in rating of sweetness
gMLS rating of e-cigarette sweetness
Change score in rating of sourness
gMLS rating of e-cigarette sourness
Change score in rating of fruitiness
gMLS rating of e-cigarette fruitiness
Change score in rating of total sensation
gMLS rating of e-cigarette total sensation
E-cigarette value
Value of e-cigarette as determined by the Multiple Choice Questionnaire (MCP) task
Number of puffs
Number of puffs taken at the end of the ad-lib vaping period
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

Full Information

First Posted
April 27, 2017
Last Updated
April 30, 2020
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT03168191
Brief Title
Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 2
Official Title
Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 2
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 2, 2017 (Actual)
Primary Completion Date
August 22, 2018 (Actual)
Study Completion Date
February 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
E-cigarette flavor
Arm Type
Experimental
Arm Description
In this arm, subjects will receive an experimental flavor. Participants will be randomly assigned to low or high dose of nicotine.
Arm Title
Menthol Flavor
Arm Type
Experimental
Arm Description
In this arm, subjects will receive a menthol flavor. Participants will be randomly assigned to low or high dose of nicotine.
Arm Title
No Flavor
Arm Type
Placebo Comparator
Arm Description
In this arm, subjects will receive no flavor. Participants will be randomly assigned to low or high dose of nicotine.
Intervention Type
Drug
Intervention Name(s)
Nicotine
Intervention Description
Participants will receive low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml)
Intervention Type
Other
Intervention Name(s)
Experimental Flavor
Intervention Description
Experimental fruit flavored e-cigarette for lab session
Intervention Type
Other
Intervention Name(s)
Menthol Flavor
Intervention Description
Menthol flavored e-cigarette for lab session
Primary Outcome Measure Information:
Title
Change score in Liking/wanting of the e-cigarette
Description
The Drug Effects Questionnaire (Soria et al) will be used to ask about liking and wanting during the lab session
Time Frame
Baseline (+10 minutes) to end of lab session (+40 minutes)
Secondary Outcome Measure Information:
Title
Change score in rating of coolness
Description
gMLS rating of e-cigarette coolness
Time Frame
Baseline (+10 minutes) to end of lab session (+40 minutes)
Title
Change score in rating of harshness/irritation
Description
gMLS rating of e-cigarette harshness/irritation
Time Frame
Baseline (+10 minutes) to end of lab session (+40 minutes)
Title
Change score in rating of sweetness
Description
gMLS rating of e-cigarette sweetness
Time Frame
Baseline (+10 minutes) to end of lab session (+40 minutes)
Title
Change score in rating of sourness
Description
gMLS rating of e-cigarette sourness
Time Frame
End of lab session (+40 minutes)
Title
Change score in rating of fruitiness
Description
gMLS rating of e-cigarette fruitiness
Time Frame
Baseline (+10 minutes) to end of lab session (+40 minutes)
Title
Change score in rating of total sensation
Description
gMLS rating of e-cigarette total sensation
Time Frame
Baseline (+10 minutes) to end of lab session (+40 minutes)
Title
E-cigarette value
Description
Value of e-cigarette as determined by the Multiple Choice Questionnaire (MCP) task
Time Frame
Baseline (+10 minutes) to end of lab session (+40 minutes)
Title
Number of puffs
Description
Number of puffs taken at the end of the ad-lib vaping period
Time Frame
End of ad-lib lab session 4 (+40 minutes)
Title
Change score in Tobacco Craving
Description
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
Time Frame
Baseline (+10 minutes) to end of lab session (+40 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana Cavallo, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Study Director
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
32297782
Citation
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.
Results Reference
derived

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Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 2

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