Nicotine Use Disorder
Conditions
Brief summary
This study is an examination of the influence of sweet and cooling flavors on the appeal and abuse potential of nicotine-containing e-cigarettes among susceptible youth.
Detailed description
Researchers will examine the influence of sweet and cooling flavors on the appeal and abuse potential of nicotine-containing e-cigarettes among susceptible youth. Participants will rate the flavor intensity, coolness, sweetness, and irritation experienced using validated rating scales. Forty youth (18-20 years of age) who have experience with e-cigarettes and will participate in 1 laboratory session. They will receive 1 nicotine concentrations (36mg/ml nicotine salt) during the session; during the session they will be exposed, in random order, to sweet (watermelon) and sweet-cooling (watermelon-menthol) flavors combined with the assigned session nicotine concentration.
Interventions
Flavor of e-liquid - sweet or tobacco
Nicotine level (36 mg/ml)
Sponsors
Study design
Masking description
Flavor and nicotine concentration is blinded to participant. Research staff and investigators are blinded to flavor order administer to participants.
Eligibility
Inclusion criteria
* Ages 18-20 years * Able to read and write * Used e-cigs at least 10 times in lifetime * Used e-cigs in past 30 days
Exclusion criteria
* Current use of non-prescription substances besides nicotine, marijuana, alcohol * Any significant current medical or psychiatric condition * Known hypersensitivity to propylene glycol * Pregnant or lactating females * Uncontrolled asthma * Nut/e-liquid flavorant allergy * current marijuana (tetrahydrocannabinol) vaping + E-cigarette or vaping use Associated Lung Injury (EVALI) symptoms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liking: Difference Score in Liking/Wanting of Each E-cigarette Condition | Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40) | The Labeled Hedonic Scale will be used to ask about liking and wanting of the e-cigarette (one item Visual Analog Scale with ratings ranging from most disliked sensation imaginable to most liked sensation imaginable with higher values indicating greater liking). Specific scale semantic structure and corresponding values: most disliked imaginable=-100, dislike extremely=-62.9, dislike very much=-41.6, dislike moderately=-17.6, dislike slightly=-5.9, neutral=0, like slightly=6.3, like moderately=17.8, like very much=44.4, like extremely=65.7, most liked imaginable=100. |
| Reinforcing Efficacy: Difference Score in Drug Effects of Each E-cigarette Condition | Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40) | Difference between e-cigarette effects for each e-cigarette condition 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). Higher values indicate stronger reinforcing efficacy (i.e., wanting/liking effects). |
| Craving: Change in Craving Score for E-cigarette | At baseline (+0 minutes), Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40) | Difference from baseline in craving for each e-cigarette condition will be measured by the Generalized Labeled Magnitude Scale (gLMS). Participants will self-report their craving for e-cigarettes 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). |
| Irritation/Harshness: Difference Score in Irritation of Harshness of Each E-cigarette Condition | Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40) | Difference in irritation at each e-cigarette condition 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). |
Countries
United States
Participant flow
Recruitment details
84 young adults (18-20 years) were screened for eligibility between November 7, 2022 and June 12, 2023 through Snapchat and referrals from previous participants.
Pre-assignment details
A total of 40 participants completed the study. Specifically, 49 out of 84 participants were randomized, but 7 did not show up and 2 withdrew. Of the 35 who were not randomized, 18 did not meet inclusion criteria and 17 did not show up.
Participants by arm
| Arm | Count |
|---|---|
| Sweet Non-menthol Then Sweet Menthol, Each With Nicotine 36mg/ml Participants attended a one-time, two-hour laboratory session with two exposures to flavored nicotine-containing e-liquids in a randomized order. They first received Durasmoke watermelon (50:50 PG/VG base) e-liquid. After a 30-minute break, they then received Durasmoke watermelon-menthol (50:50 PG/VG base) e-liquid, each with a nicotine salt concentration of 36 mg/mL.
Flavoring Agents: Flavor of e-liquid - sweet or tobacco
Nicotine: Nicotine level (36 mg/ml) | 20 |
| Sweet Menthol Then Sweet Non-menthol, Each With Nicotine 36mg/ml Participants attended a one-time, two-hour laboratory session with two exposures to flavored nicotine-containing e-liquids in a randomized order. They first received Durasmoke watermelon-menthol (50:50 PG/VG base) e-liquid. After a 30-minute break, they then received Durasmoke watermelon (50:50 PG/VG base) e-liquid, each with a nicotine salt concentration of 36 mg/mL.
Flavoring Agents: Flavor of e-liquid - sweet or tobacco
Nicotine: Nicotine level (36 mg/ml) | 22 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (2 Hours) | Adverse Event | 0 | 2 |
Baseline characteristics
| Characteristic | Sweet Non-menthol Then Sweet Menthol, Each With Nicotine 36mg/ml | Sweet Menthol Then Sweet Non-menthol, Each With Nicotine 36mg/ml | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 22 Participants | 42 Participants |
| Age, Continuous | 19.0 years STANDARD_DEVIATION 0.7 | 19.2 years STANDARD_DEVIATION 0.8 | 19.1 years STANDARD_DEVIATION 0.8 |
| Currently enrolled in a degree program | 17 Participants | 15 Participants | 32 Participants |
| Ever vaped cooling flavor | 20 Participants | 22 Participants | 42 Participants |
| Grade Barely passing (D's) | 0 Participants | 1 Participants | 1 Participants |
| Grade Excellent (A's) | 14 Participants | 13 Participants | 27 Participants |
| Grade Fair (C's) | 1 Participants | 2 Participants | 3 Participants |
| Grade Good (B's) | 5 Participants | 6 Participants | 11 Participants |
| Past-month other tobacco use | 12 Participants | 12 Participants | 24 Participants |
| Past-month vaped THC | 18 Participants | 7 Participants | 25 Participants |
| Preferred e-cigarette device Any pod device other than a JUUL | 2 Participants | 1 Participants | 3 Participants |
| Preferred e-cigarette device Disposable pod device | 16 Participants | 20 Participants | 36 Participants |
| Preferred e-cigarette device JUUL | 1 Participants | 1 Participants | 2 Participants |
| Preferred e-cigarette device Vape pen | 1 Participants | 0 Participants | 1 Participants |
| Preferred e-cigarette nicotine level 50-59mg/mL or 5.0-5.9% | 14 Participants | 16 Participants | 30 Participants |
| Preferred e-cigarette nicotine level I don't know the concentration | 2 Participants | 5 Participants | 7 Participants |
| Preferred e-cigarette nicotine level Other concentrations | 4 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 11 Participants | 18 Participants | 29 Participants |
| Region of Enrollment United States | 20 participants | 22 participants | 42 participants |
| Sex: Female, Male Female | 11 Participants | 11 Participants | 22 Participants |
| Sex: Female, Male Male | 9 Participants | 11 Participants | 20 Participants |
| Vaping age of onset | 14.8 years STANDARD_DEVIATION 1.9 | 15.6 years STANDARD_DEVIATION 1.7 | 15.2 years STANDARD_DEVIATION 1.8 |
| Vaping frequency | 6.0 days per week STANDARD_DEVIATION 1.8 | 6.1 days per week STANDARD_DEVIATION 1.4 | 6.1 days per week STANDARD_DEVIATION 1.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 42 |
| other Total, other adverse events | 0 / 40 | 2 / 42 |
| serious Total, serious adverse events | 0 / 40 | 0 / 42 |
Outcome results
Craving: Change in Craving Score for E-cigarette
Difference from baseline in craving for each e-cigarette condition will be measured by the Generalized Labeled Magnitude Scale (gLMS). Participants will self-report their craving for e-cigarettes 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: At baseline (+0 minutes), Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Sweet Non-menthol, Nicotine 36mg/ml | Craving: Change in Craving Score for E-cigarette | 2.72 score on a scale | Standard Error 0.22 |
| Sweet Menthol, Nicotine 36mg/ml | Craving: Change in Craving Score for E-cigarette | 2.43 score on a scale | Standard Error 0.22 |
Irritation/Harshness: Difference Score in Irritation of Harshness of Each E-cigarette Condition
Difference in irritation at each e-cigarette condition 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: Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Sweet Non-menthol, Nicotine 36mg/ml | Irritation/Harshness: Difference Score in Irritation of Harshness of Each E-cigarette Condition | 20.92 score on a scale | Standard Error 1.68 |
| Sweet Menthol, Nicotine 36mg/ml | Irritation/Harshness: Difference Score in Irritation of Harshness of Each E-cigarette Condition | 22.86 score on a scale | Standard Error 1.68 |
Liking: Difference Score in Liking/Wanting of Each E-cigarette Condition
The Labeled Hedonic Scale will be used to ask about liking and wanting of the e-cigarette (one item Visual Analog Scale with ratings ranging from most disliked sensation imaginable to most liked sensation imaginable with higher values indicating greater liking). Specific scale semantic structure and corresponding values: most disliked imaginable=-100, dislike extremely=-62.9, dislike very much=-41.6, dislike moderately=-17.6, dislike slightly=-5.9, neutral=0, like slightly=6.3, like moderately=17.8, like very much=44.4, like extremely=65.7, most liked imaginable=100.
Time frame: Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40)
Population: After each of the two puff bouts, we evaluated participants' reference for the overall experience of the e-cigarette using the LHS, which is a bipolar category ratio scale that spans from -100 (most disliked) to 100 (most liked), with 'neither liked nor disliked' positioned as the midpoint. The scale labels were places along the scale based on their semantic magnitude.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Sweet Non-menthol, Nicotine 36mg/ml | Liking: Difference Score in Liking/Wanting of Each E-cigarette Condition | 1.268 score on a scale | Standard Error 3.158 |
| Sweet Menthol, Nicotine 36mg/ml | Liking: Difference Score in Liking/Wanting of Each E-cigarette Condition | -3.916 score on a scale | Standard Error 3.158 |
Reinforcing Efficacy: Difference Score in Drug Effects of Each E-cigarette Condition
Difference between e-cigarette effects for each e-cigarette condition 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). Higher values indicate stronger reinforcing efficacy (i.e., wanting/liking effects).
Time frame: Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40)
Population: To examine wanting/liking, we used subscales from the Drug Effects Questionnaire (DEQ), following the approach established in previous literature. Four items were used to measure wanting/liking effects (the average of 'I feel good e-cigarette effects', 'I want more of that e-cigarette I received', 'I feel the e-cigarette strength', and 'I like the e-cigarette effect').
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Sweet Non-menthol, Nicotine 36mg/ml | Reinforcing Efficacy: Difference Score in Drug Effects of Each E-cigarette Condition | 37.06 score on a scale | Standard Error 3.01 |
| Sweet Menthol, Nicotine 36mg/ml | Reinforcing Efficacy: Difference Score in Drug Effects of Each E-cigarette Condition | 35.18 score on a scale | Standard Error 3.01 |