Back to resultsThe Interaction of Flavor With Nicotine Form in Adult Smokers
Primary Purpose
Nicotine Dependence
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nicotine form
E-cigarette experimental flavor
Sponsored by
About this trial
This is an interventional other trial for Nicotine Dependence
Eligibility Criteria
Inclusion Criteria:
- At least 21 years old, able to read and write, use of combustible
Exclusion Criteria:
-
Sites / Locations
- Pierce Laboratory
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
E-cigarette flavor
E-cigarette nicotine form
Arm Description
In this arm, participants will receive two experimental e-cigarette flavors
In this arm, participants will receive two forms of nicotine in an e-cigarette
Outcomes
Primary Outcome Measures
Changes in Liking of E-cigarette Overall
Following each puff, each participant was assessed to determine if they liked/disliked the overall e-cigarette experience using the Labeled Hedonic Scale (LHS), a bipolar category-ratio scale with 5 symmetrical semantic labels positioned on the scale per their semantic magnitude that ranges from -100 (Most Disliked) to 100 (Most Liked) with "Neither Liked nor Disliked" at the midpoint.
Changes in Liking of E-cigarette Flavor
Following each puff, each participant was assessed to determine if they liked/disliked the flavors in the e-cigarette experience using the Labeled Hedonic Scale (LHS), a bipolar category-ratio scale with 5 symmetrical semantic labels positioned on the scale per their semantic magnitude that ranges from -100 (Most Disliked) to 100 (Most Liked) with "Neither Liked nor Disliked" at the midpoint.
Secondary Outcome Measures
gLMS: Sweetness
Immediately following each puff, participants rated the sensory effects they experienced (harshness/irritation, coolness, sweetness) "right now" on the general version of the Labeled Magnitude Scale (gLMS). The gLMS is a category ratio scale with 7 semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically per their empirically determined semantic magnitudes, with responses coded on a 0-100 scale. The scores have been log transformed with responses coded on a 0-4.6 natural log transformed scale. The higher the score, the higher the intensity for the outcome (i.e., irritation, sweetness, coolness).
gLMS: Coolness
Immediately following each puff, participants rated the sensory effects they experienced (harshness/irritation, coolness, sweetness) "right now" on the general version of the Labeled Magnitude Scale (gLMS). The gLMS is a category ratio scale with 7 semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically per their empirically determined semantic magnitudes, with responses coded on a 0-100 scale. The scores have been log transformed with responses coded on a 0-4.6 natural log transformed scale. The higher the score, the higher the intensity for the outcome (i.e., irritation, sweetness, coolness).
gLMS: Irritation
Immediately following each puff, participants rated the sensory effects they experienced (harshness/irritation, coolness, sweetness) "right now" on the general version of the Labeled Magnitude Scale (gLMS). The gLMS is a category ratio scale with 7 semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically per their empirically determined semantic magnitudes, with responses coded on a 0-100 scale. The scores have been log transformed with responses coded on a 0-4.6 natural log transformed scale. The higher the score, the higher the intensity for the outcome (i.e., irritation, sweetness, coolness).
Number of Puffs
The number of puffs on each device were counter per participant across each level of the study design. The scores have been log transformed.
Full Information
NCT ID
NCT04262817
First Posted
February 4, 2020
Last Updated
May 1, 2023
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT04262817
Brief Title
The Interaction of Flavor With Nicotine Form in Adult Smokers
Official Title
The Interaction of Flavor With Nicotine Form in Adult Smokers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
January 10, 2022 (Actual)
Study Completion Date
February 2, 2022 (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
5. Study Description
Brief Summary
This study seeks to elucidate the impact of e-cigarette flavor on subjective effects and nicotine exposure from e-cigarettes containing different forms of nicotine.
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
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
E-cigarette flavor
Arm Type
Experimental
Arm Description
In this arm, participants will receive two experimental e-cigarette flavors
Arm Title
E-cigarette nicotine form
Arm Type
Experimental
Arm Description
In this arm, participants will receive two forms of nicotine in an e-cigarette
Intervention Type
Drug
Intervention Name(s)
Nicotine form
Intervention Description
participants will receive 36mg/ml nicotine salt and freebase nicotine
Intervention Type
Other
Intervention Name(s)
E-cigarette experimental flavor
Intervention Description
Participants will receive menthol and tobacco flavored e-cigarettes
Primary Outcome Measure Information:
Title
Changes in Liking of E-cigarette Overall
Description
Following each puff, each participant was assessed to determine if they liked/disliked the overall e-cigarette experience using the Labeled Hedonic Scale (LHS), a bipolar category-ratio scale with 5 symmetrical semantic labels positioned on the scale per their semantic magnitude that ranges from -100 (Most Disliked) to 100 (Most Liked) with "Neither Liked nor Disliked" at the midpoint.
Time Frame
up to 3 weeks
Title
Changes in Liking of E-cigarette Flavor
Description
Following each puff, each participant was assessed to determine if they liked/disliked the flavors in the e-cigarette experience using the Labeled Hedonic Scale (LHS), a bipolar category-ratio scale with 5 symmetrical semantic labels positioned on the scale per their semantic magnitude that ranges from -100 (Most Disliked) to 100 (Most Liked) with "Neither Liked nor Disliked" at the midpoint.
Time Frame
up to 3 weeks
Secondary Outcome Measure Information:
Title
gLMS: Sweetness
Description
Immediately following each puff, participants rated the sensory effects they experienced (harshness/irritation, coolness, sweetness) "right now" on the general version of the Labeled Magnitude Scale (gLMS). The gLMS is a category ratio scale with 7 semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically per their empirically determined semantic magnitudes, with responses coded on a 0-100 scale. The scores have been log transformed with responses coded on a 0-4.6 natural log transformed scale. The higher the score, the higher the intensity for the outcome (i.e., irritation, sweetness, coolness).
Time Frame
up to 3 weeks
Title
gLMS: Coolness
Description
Immediately following each puff, participants rated the sensory effects they experienced (harshness/irritation, coolness, sweetness) "right now" on the general version of the Labeled Magnitude Scale (gLMS). The gLMS is a category ratio scale with 7 semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically per their empirically determined semantic magnitudes, with responses coded on a 0-100 scale. The scores have been log transformed with responses coded on a 0-4.6 natural log transformed scale. The higher the score, the higher the intensity for the outcome (i.e., irritation, sweetness, coolness).
Time Frame
up to 3 weeks
Title
gLMS: Irritation
Description
Immediately following each puff, participants rated the sensory effects they experienced (harshness/irritation, coolness, sweetness) "right now" on the general version of the Labeled Magnitude Scale (gLMS). The gLMS is a category ratio scale with 7 semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically per their empirically determined semantic magnitudes, with responses coded on a 0-100 scale. The scores have been log transformed with responses coded on a 0-4.6 natural log transformed scale. The higher the score, the higher the intensity for the outcome (i.e., irritation, sweetness, coolness).
Time Frame
up to 3 weeks
Title
Number of Puffs
Description
The number of puffs on each device were counter per participant across each level of the study design. The scores have been log transformed.
Time Frame
up to 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
At least 21 years old, able to read and write, use of combustible
Exclusion Criteria:
-
Facility Information:
Facility Name
Pierce Laboratory
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Interaction of Flavor With Nicotine Form in Adult Smokers
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