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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
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 - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

First Posted
August 13, 2018
Last Updated
March 10, 2023
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
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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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