Nicotine E-Cigarette Use
Conditions
Brief summary
This study looks at the effect of manipulating the water concentration of certain e-liquids on sensory perception.
Detailed description
This study looks at the effect of manipulating water concentration on e-cigarettes that contain aldehyde flavor chemicals on sensory perception. Regular e-cigarette users will be asked to complete 2 lab sessions in which they will sample 4 nicotine containing e-liquids. Each e-liquid will be sampled in four water concentration manipulations. Researchers will examine influence of flavor and water concentrations on sensory experience including appeal/liking and irritation and harshness.
Interventions
OTHERWater Concentration 1
E-liquid containing 36mg/ml pronated nicotine will be administered with no alteration to water concentration.
OTHERWater Concentration 2
E-liquid containing 36mg/ml pronated nicotine will be administered with 5% total water concentration of e-liquid.
OTHERWater Concentration 3
E-liquid containing 36mg/ml pronated nicotine will be administered with 10% total water concentration of e-liquid.
OTHERWater Concentration 4
E-liquid containing 36mg/ml pronated nicotine will be administered with 20% total water concentration of e-liquid.
Sponsors
National Institute on Drug Abuse (NIDA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
Double blind, both participant and investigator will be blind to e-liquid being administered
Intervention model description
Within subject design, all participants will receive all e-liquid flavors/water concentrations
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* at least 21 years old * able to read/write * \>/= 6 mths e-cig use * regular e-cig use (\>/= 4 days/week) * use of flavored e-cigs * use of nicotine containing e-cigs * urine cotinine \>/= 200ng/ml * no plan to quit e-cig use
Exclusion criteria
* breastfeeding, pregnant, trying to become pregnant * Medical conditions that increase risk of respiratory problems among participants * Current use of illegal substances * Medical conditions increasing risk of respiratory problems in nonpatient populations * Current diagnosis of an untreated psychiatric condition * Not fully vaccinated for Coronavirus-19
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Irritation/Harshness | immediately after intervention, up to 15 minutes | 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). |
| Appeal Assessed Using the Labeled Hedonic Scale (LHS) Ranging From -100 to 100 | immediately after intervention, up to 15 minutes | Change 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). |
| Appeal Assessed Using the Drug Effects Questionnaire (DEQ) | immediately after intervention, up to 15 minutes | Change 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). |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Experimental Order A-D (All Participants Received All Conditions, Order Was Randomized) All participants received all conditions, order was randomized | 31 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Experimental Order A-D (All Participants Received All Conditions, Order Was Randomized) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants |
| Age, Continuous | 35.3 years STANDARD_DEVIATION 10.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Region of Enrollment United States | 31 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 8 | 0 / 6 | 0 / 7 |
| other Total, other adverse events | 0 / 10 | 0 / 8 | 0 / 6 | 0 / 7 |
| serious Total, serious adverse events | 0 / 10 | 0 / 8 | 0 / 6 | 0 / 7 |
Outcome results
Primary
Appeal Assessed Using the Drug Effects Questionnaire (DEQ)
Change 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).
Time frame: immediately after intervention, up to 15 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Water Added | Appeal Assessed Using the Drug Effects Questionnaire (DEQ) | 48.99 score on a scale | Standard Error 3.71 |
| 5% Water Added | Appeal Assessed Using the Drug Effects Questionnaire (DEQ) | 47.94 score on a scale | Standard Error 3.71 |
| 10% Water Added | Appeal Assessed Using the Drug Effects Questionnaire (DEQ) | 45.94 score on a scale | Standard Error 3.71 |
| 20% Water Added | Appeal Assessed Using the Drug Effects Questionnaire (DEQ) | 42.97 score on a scale | Standard Error 3.72 |
p-value: <0.05Mixed Models Analysis
Primary
Appeal Assessed Using the Labeled Hedonic Scale (LHS) Ranging From -100 to 100
Change 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).
Time frame: immediately after intervention, up to 15 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Water Added | 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 |
| 5% Water Added | Appeal Assessed Using the Labeled Hedonic Scale (LHS) Ranging From -100 to 100 | 10.41 score on a scale (-100 to 100) | Standard Deviation 3.79 |
| 10% Water Added | Appeal Assessed Using the Labeled Hedonic Scale (LHS) Ranging From -100 to 100 | 7.1 score on a scale (-100 to 100) | Standard Deviation 3.79 |
| 20% Water Added | Appeal Assessed Using the Labeled Hedonic Scale (LHS) Ranging From -100 to 100 | 3.87 score on a scale (-100 to 100) | Standard Deviation 3.79 |
p-value: <0.05Mixed Models Analysis
Primary
Irritation/Harshness
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).
Time frame: immediately after intervention, up to 15 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Water Added | Irritation/Harshness | 1.04 units on a scale | Standard Deviation 0.05 |
| 5% Water Added | Irritation/Harshness | 1.07 units on a scale | Standard Deviation 0.05 |
| 10% Water Added | Irritation/Harshness | 1.03 units on a scale | Standard Deviation 0.05 |
| 20% Water Added | Irritation/Harshness | 1.01 units on a scale | Standard Deviation 0.05 |
p-value: 0.0014Mixed Models Analysis