Effects of E-Cigarette Flavors on Adults TCORS 2.0
Primary Purpose
Nicotine Use Disorder
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nicotine
Flavor
Sponsored by
About this trial
This is an interventional other trial for Nicotine Use Disorder
Eligibility Criteria
Inclusion Criteria:
- Ages 18-24 years or 35 -50 years
- Able to read and write
- Smoking > 10 cigarettes or cigars/day
- Willing to abstain from regular smoking for 2 weeks and use only e-cigarettes
- Not seeking treatment to stop smoking
- No regular 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 CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Low nicotine, tobacco
Low nicotine, menthol
Low nicotine, strawberry
High nicotine, tobacco
High nicotine, menthol
Hign Nicotine, strawberry
Arm Description
6 mg nicotine combined with tobacco flavored e-juice
6 mg nicotine combined with menthol flavored e-juice
6 mg nicotine combined with strawberry flavored e-juice
18 mg nicotine combined with tobacco flavored e-juice
18 mg nicotine combined with menthol flavored e-juice
18 mg nicotine combined with strawberry flavored e-juice
Outcomes
Primary Outcome Measures
Change score in liking/wanting of e-cigarette
The Labeled Hedonic Scale (LHS; Lim et al., 2009) will be used to ask about liking and wanting of the e-cigarette (one item VAS scale with ratings from most disliked sensation imaginable to most liked sensation imaginable with higher values indicating greater liking)
Secondary Outcome Measures
Full Information
NCT ID
NCT03635333
First Posted
August 13, 2018
Last Updated
March 10, 2023
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT03635333
Brief Title
Effects of E-Cigarette Flavors on Adults TCORS 2.0
Official Title
Effects of E-Cigarette Flavors on Adults
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2019 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study looks at the effects of flavors when administered with nicotine in e-cigarettes in younger and older adult cigarette smokers.
Detailed Description
This study looks at the effects of flavors when administered with nicotine in e-cigarettes in younger and older adult cigarette smokers. Regular cigarette smokers who do not want to quit smoking will be asked to complete 3 lab sessions in which they will use an e-cigarette and complete questionnaires. This will be followed by a two-week period where participants are asked to stop using cigarettes and other tobacco products and to only use the e-cigarettes provided. Researchers will examine the influence of flavors (sweet, cool, tobacco) on reward (liking/wanting) from e-cigs containing one of two nicotine concentrations (6 mg/ml, 18 mg/ml) following acute tobacco abstinence.
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
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low nicotine, tobacco
Arm Type
Experimental
Arm Description
6 mg nicotine combined with tobacco flavored e-juice
Arm Title
Low nicotine, menthol
Arm Type
Experimental
Arm Description
6 mg nicotine combined with menthol flavored e-juice
Arm Title
Low nicotine, strawberry
Arm Type
Experimental
Arm Description
6 mg nicotine combined with strawberry flavored e-juice
Arm Title
High nicotine, tobacco
Arm Type
Experimental
Arm Description
18 mg nicotine combined with tobacco flavored e-juice
Arm Title
High nicotine, menthol
Arm Type
Experimental
Arm Description
18 mg nicotine combined with menthol flavored e-juice
Arm Title
Hign Nicotine, strawberry
Arm Type
Experimental
Arm Description
18 mg nicotine combined with strawberry flavored e-juice
Intervention Type
Drug
Intervention Name(s)
Nicotine
Intervention Description
Nicotine level (6 or 18 mg)
Intervention Type
Drug
Intervention Name(s)
Flavor
Intervention Description
Flavor of e-juice (tobacco, menthol, strawberry)
Primary Outcome Measure Information:
Title
Change score in liking/wanting of e-cigarette
Description
The Labeled Hedonic Scale (LHS; Lim et al., 2009) will be used to ask about liking and wanting of the e-cigarette (one item VAS scale with ratings from most disliked sensation imaginable to most liked sensation imaginable with higher values indicating greater liking)
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
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ages 18-24 years or 35 -50 years
Able to read and write
Smoking > 10 cigarettes or cigars/day
Willing to abstain from regular smoking for 2 weeks and use only e-cigarettes
Not seeking treatment to stop smoking
No regular 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danielle Davis, PhD
Phone
203-974-7607
Email
danielle.davis@yale.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Liss
Email
thomas.liss@yale.edu
Facility Information:
Facility Name
CMHC, Substance Abuse Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Davis, PhD
Phone
203-974-7607
Email
danielle.davis@yale.edu
First Name & Middle Initial & Last Name & Degree
Thomas Liss
Email
thomas.liss@yale.edu
First Name & Middle Initial & Last Name & Degree
Suchitra Krishnan-Sarin, Ph.D.
12. IPD Sharing Statement
Learn more about this trial
Effects of E-Cigarette Flavors on Adults TCORS 2.0
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