Trial Outcomes & Findings for Water Content in E-Liquids (NCT NCT05257109)
NCT ID: NCT05257109
Last Updated: 2024-10-22
Results Overview
Change in irritation at each water level 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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
immediately after intervention, up to 15 minutes
Results posted on
2024-10-22
Participant Flow
108 people were phone screened for eligibility. 54 attended an in person intake appointment. Of those, 31 met inclusion criteria and were enrolled in the study and 30 participants complete all study procedures.
31 of 54 intakes were randomized to receive study procedures. 22 people did not meet inclusion criteria at the time of intake and were not enrolled and 1 person was not available at the time of the lab sessions to participate.
Participant milestones
| Measure |
Experimental E-Liquid Order "A"
All participants will be given all e-liquids (i.e. all 16 flavor\*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water will be presented in the same order from hypothesized least irritating to most irritating.
Water Concentration 1: E-liquid containing 36mg/ml pronated nicotine will be administered with no alteration to water concentration.
Water Concentration 2: E-liquid containing 36mg/ml pronated nicotine will be administered with 5% total water concentration of e-liquid.
Water Concentration 3: E-liquid containing 36mg/ml pronated nicotine will be administered with 10% total water concentration of e-liquid.
Water Concentration 4: E-liquid containing 36mg/ml pronated nicotine will be administered with 20% total water concentration of e-liquid.
|
Experimental E-Liquid Order "B"
All participants will be given all e-liquids (i.e. all 16 flavor\*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water will be presented in the same order from hypothesized least irritating to most irritating.
Water Concentration 1: E-liquid containing 36mg/ml pronated nicotine will be administered with no alteration to water concentration.
Water Concentration 2: E-liquid containing 36mg/ml pronated nicotine will be administered with 5% total water concentration of e-liquid.
Water Concentration 3: E-liquid containing 36mg/ml pronated nicotine will be administered with 10% total water concentration of e-liquid.
Water Concentration 4: E-liquid containing 36mg/ml pronated nicotine will be administered with 20% total water concentration of e-liquid.
|
Experimental E-Liquid Order "C"
All participants will be given all e-liquids (i.e. all 16 flavor\*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water will be presented in the same order from hypothesized least irritating to most irritating.
Water Concentration 1: E-liquid containing 36mg/ml pronated nicotine will be administered with no alteration to water concentration.
Water Concentration 2: E-liquid containing 36mg/ml pronated nicotine will be administered with 5% total water concentration of e-liquid.
Water Concentration 3: E-liquid containing 36mg/ml pronated nicotine will be administered with 10% total water concentration of e-liquid.
Water Concentration 4: E-liquid containing 36mg/ml pronated nicotine will be administered with 20% total water concentration of e-liquid.
|
Experimental E-Liquid Order "D"
All participants will be given all e-liquids (i.e. all 16 flavor\*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water will be presented in the same order from hypothesized least irritating to most irritating.
Water Concentration 1: E-liquid containing 36mg/ml pronated nicotine will be administered with no alteration to water concentration.
Water Concentration 2: E-liquid containing 36mg/ml pronated nicotine will be administered with 5% total water concentration of e-liquid.
Water Concentration 3: E-liquid containing 36mg/ml pronated nicotine will be administered with 10% total water concentration of e-liquid.
Water Concentration 4: E-liquid containing 36mg/ml pronated nicotine will be administered with 20% total water concentration of e-liquid.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
8
|
6
|
7
|
|
Overall Study
COMPLETED
|
9
|
8
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Experimental E-Liquid Order "A"
All participants will be given all e-liquids (i.e. all 16 flavor\*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water will be presented in the same order from hypothesized least irritating to most irritating.
Water Concentration 1: E-liquid containing 36mg/ml pronated nicotine will be administered with no alteration to water concentration.
Water Concentration 2: E-liquid containing 36mg/ml pronated nicotine will be administered with 5% total water concentration of e-liquid.
Water Concentration 3: E-liquid containing 36mg/ml pronated nicotine will be administered with 10% total water concentration of e-liquid.
Water Concentration 4: E-liquid containing 36mg/ml pronated nicotine will be administered with 20% total water concentration of e-liquid.
|
Experimental E-Liquid Order "B"
All participants will be given all e-liquids (i.e. all 16 flavor\*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water will be presented in the same order from hypothesized least irritating to most irritating.
Water Concentration 1: E-liquid containing 36mg/ml pronated nicotine will be administered with no alteration to water concentration.
Water Concentration 2: E-liquid containing 36mg/ml pronated nicotine will be administered with 5% total water concentration of e-liquid.
Water Concentration 3: E-liquid containing 36mg/ml pronated nicotine will be administered with 10% total water concentration of e-liquid.
Water Concentration 4: E-liquid containing 36mg/ml pronated nicotine will be administered with 20% total water concentration of e-liquid.
|
Experimental E-Liquid Order "C"
All participants will be given all e-liquids (i.e. all 16 flavor\*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water will be presented in the same order from hypothesized least irritating to most irritating.
Water Concentration 1: E-liquid containing 36mg/ml pronated nicotine will be administered with no alteration to water concentration.
Water Concentration 2: E-liquid containing 36mg/ml pronated nicotine will be administered with 5% total water concentration of e-liquid.
Water Concentration 3: E-liquid containing 36mg/ml pronated nicotine will be administered with 10% total water concentration of e-liquid.
Water Concentration 4: E-liquid containing 36mg/ml pronated nicotine will be administered with 20% total water concentration of e-liquid.
|
Experimental E-Liquid Order "D"
All participants will be given all e-liquids (i.e. all 16 flavor\*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water will be presented in the same order from hypothesized least irritating to most irritating.
Water Concentration 1: E-liquid containing 36mg/ml pronated nicotine will be administered with no alteration to water concentration.
Water Concentration 2: E-liquid containing 36mg/ml pronated nicotine will be administered with 5% total water concentration of e-liquid.
Water Concentration 3: E-liquid containing 36mg/ml pronated nicotine will be administered with 10% total water concentration of e-liquid.
Water Concentration 4: E-liquid containing 36mg/ml pronated nicotine will be administered with 20% total water concentration of e-liquid.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Water Content in E-Liquids
Baseline characteristics by cohort
| Measure |
Experimental Order A-D (All Participants Received All Conditions, Order Was Randomized)
n=31 Participants
All participants received all conditions, order was randomized
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
|
Age, Continuous
|
35.3 years
STANDARD_DEVIATION 10.4 • n=39 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: immediately after intervention, up to 15 minutesChange in irritation at each water level 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).
Outcome measures
| Measure |
No Water Added
n=31 Participants
All participants received all conditions, order was randomized
|
5% Water Added
n=31 Participants
All participants received all conditions
|
10% Water Added
n=31 Participants
All participants received all conditions.
|
20% Water Added
n=31 Participants
All participants received all conditions.
|
|---|---|---|---|---|
|
Irritation/Harshness
|
1.04 units on a scale
Standard Deviation .05
|
1.07 units on a scale
Standard Deviation .05
|
1.03 units on a scale
Standard Deviation .05
|
1.01 units on a scale
Standard Deviation .05
|
PRIMARY outcome
Timeframe: immediately after intervention, up to 15 minutesChange in appeal at each water level as measured by the computerized Labeled Hedonic Scale (LHS). Participants will self-report their responses using a computer mouse to indicate where on the scale response falls. The Labeled Hedonic Scale (LHS) is a bipolar category ratio scale that ranges from -100 (most disliked, minimum score) to 100 (most liked, maximum score), with 'neither liked nor disliked' as midpoint (0). Scores range from -100 (minimum) to 100 (maximum). Negative scores indicate dislike (lack of appeal) and positive scores indicate liking (appeal).
Outcome measures
| Measure |
No Water Added
n=31 Participants
All participants received all conditions, order was randomized
|
5% Water Added
n=31 Participants
All participants received all conditions
|
10% Water Added
n=31 Participants
All participants received all conditions.
|
20% Water Added
n=31 Participants
All participants received all conditions.
|
|---|---|---|---|---|
|
Appeal Assessed Using the Labeled Hedonic Scale (LHS) Ranging From -100 to 100
|
9.91 score on a scale (-100 to 100)
Standard Deviation 3.78
|
10.41 score on a scale (-100 to 100)
Standard Deviation 3.79
|
7.1 score on a scale (-100 to 100)
Standard Deviation 3.79
|
3.87 score on a scale (-100 to 100)
Standard Deviation 3.79
|
PRIMARY outcome
Timeframe: immediately after intervention, up to 15 minutesChange in appeal at each water level 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).
Outcome measures
| Measure |
No Water Added
n=31 Participants
All participants received all conditions, order was randomized
|
5% Water Added
n=31 Participants
All participants received all conditions
|
10% Water Added
n=31 Participants
All participants received all conditions.
|
20% Water Added
n=31 Participants
All participants received all conditions.
|
|---|---|---|---|---|
|
Appeal Assessed Using the Drug Effects Questionnaire (DEQ)
|
48.99 score on a scale
Standard Error 3.71
|
47.94 score on a scale
Standard Error 3.71
|
45.94 score on a scale
Standard Error 3.71
|
42.97 score on a scale
Standard Error 3.72
|
Adverse Events
Experimental Order A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental Order B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental Order C
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental Order D
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place