Nicotine Dependence
Conditions
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.
Interventions
DRUGNicotine form
participants will receive 36mg/ml nicotine salt and freebase nicotine
OTHERE-cigarette experimental flavor
Participants will receive menthol and tobacco flavored e-cigarettes
Sponsors
National Institute on Drug Abuse (NIDA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* At least 21 years old, able to read and write, use of combustible
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Liking of E-cigarette Overall | up to 3 weeks | 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 | up to 3 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| gLMS: Sweetness | up to 3 weeks | 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 | up to 3 weeks | 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 | up to 3 weeks | 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 | up to 3 weeks | The number of puffs on each device were counter per participant across each level of the study design. The scores have been log transformed. |
Countries
United States
Participant flow
Pre-assignment details
20 participants were initially enrolled but only 16 took part in the actual study.
Participants by arm
| Arm | Count |
|---|---|
| Overall Participants As a crossover study with randomized order, presented are the participant characteristics of all participants that were enrolled and participated in the study. | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Overall Participants |
|---|---|
| Age, Continuous | 39.3 years STANDARD_DEVIATION 9.1 |
| Age first smoked whole cigarette | 16.1 years STANDARD_DEVIATION 4.4 |
| Age first tried e-cigarette | 32.1 years STANDARD_DEVIATION 9.5 |
| cigarette dependence | 2.4 units on a scale STANDARD_DEVIATION 0.7 |
| Cigarettes smoked per day | 12.9 cigarettes STANDARD_DEVIATION 5 |
| Days used of e-cigarettes in past 28 days | 14.9 days STANDARD_DEVIATION 10.7 |
| e-cigarette dependence | 1.5 units on a scale STANDARD_DEVIATION 1.1 |
| Education Level Associate Degree | 4 Participants |
| Education Level Bachelor's Degree | 3 Participants |
| Education Level GED or equivalent | 3 Participants |
| Education Level High School Graduate | 2 Participants |
| Education Level Some college, no degree | 4 Participants |
| Past Year Income $0-35,000 | 9 Participants |
| Past Year Income $100,001 or more | 1 Participants |
| Past Year Income $35,001-50,000 | 1 Participants |
| Past Year Income $50,001-75,000 | 2 Participants |
| Past Year Income $75,001-100,000 | 3 Participants |
| Race/Ethnicity, Customized Biracial/Other | 1 Participants |
| Race/Ethnicity, Customized Hispanic | 2 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 4 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 9 Participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 11 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 / 16 | 0 / 16 | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 |
Outcome results
Primary
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.
Time frame: up to 3 weeks
Population: Participants that enrolled and participated in the overall study.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Participants | Changes in Liking of E-cigarette Flavor | Nicotine Salt | 4.1 score on a scale | Standard Error 4.6 |
| Overall Participants | Changes in Liking of E-cigarette Flavor | Freebase Nicotine | 0.0 score on a scale | Standard Error 6.5 |
| Overall Participants | Changes in Liking of E-cigarette Flavor | Menthol Flavor | 6.3 score on a scale | Standard Error 5.7 |
| Overall Participants | Changes in Liking of E-cigarette Flavor | Tobacco Flavor | 2.2 score on a scale | Standard Error 6.2 |
Comparison: Comparison of Nicotine type.p-value: 0.38Mixed Models Analysis
Comparison: Comparison of Flavor type.p-value: 0.85Mixed Models Analysis
Primary
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.
Time frame: up to 3 weeks
Population: Participants that enrolled and participated in the overall study.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Participants | Changes in Liking of E-cigarette Overall | Nicotine Salt | 14.2 score on a scale | Standard Error 6 |
| Overall Participants | Changes in Liking of E-cigarette Overall | Freebase Nicotine | 5.3 score on a scale | Standard Error 6.6 |
| Overall Participants | Changes in Liking of E-cigarette Overall | Menthol Flavor | 11.9 score on a scale | Standard Error 7 |
| Overall Participants | Changes in Liking of E-cigarette Overall | Tobacco Flavor | 2.2 score on a scale | Standard Error 6.2 |
Comparison: Comparison of Nicotine type.p-value: 0.01Mixed Models Analysis
Comparison: Comparison of Flavor type.p-value: 0.34Mixed Models Analysis
Secondary
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).
Time frame: up to 3 weeks
Population: Participants that enrolled and participated in the overall study.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Participants | gLMS: Coolness | Nicotine Salt | 1.9 score on a scale | Standard Error 0.2 |
| Overall Participants | gLMS: Coolness | Freebase Nicotine | 1.7 score on a scale | Standard Error 0.2 |
| Overall Participants | gLMS: Coolness | Menthol Flavor | 2.0 score on a scale | Standard Error 0.2 |
| Overall Participants | gLMS: Coolness | Tobacco Flavor | 1.6 score on a scale | Standard Error 0.3 |
Comparison: Comparison of Nicotine type.p-value: 0.43Mixed Models Analysis
Comparison: Comparison of Flavor type.p-value: 0.05Mixed Models Analysis
Secondary
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).
Time frame: up to 3 weeks
Population: Participants that enrolled and participated in the overall study.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Participants | gLMS: Irritation | Nicotine Salt | 2.1 score on a scale | Standard Error 0.3 |
| Overall Participants | gLMS: Irritation | Freebase Nicotine | 2.6 score on a scale | Standard Error 0.2 |
| Overall Participants | gLMS: Irritation | Menthol Flavor | 2.1 score on a scale | Standard Error 0.3 |
| Overall Participants | gLMS: Irritation | Tobacco Flavor | 2.5 score on a scale | Standard Error 0.2 |
Comparison: Comparison of Nicotine type.p-value: 0.05Mixed Models Analysis
Comparison: Comparison of Flavor type.p-value: 0.04Mixed Models Analysis
Secondary
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).
Time frame: up to 3 weeks
Population: Participants that enrolled and participated in the overall study.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Participants | gLMS: Sweetness | Nicotine Salt | 2.1 score on a scale | Standard Error 0.3 |
| Overall Participants | gLMS: Sweetness | Freebase Nicotine | 2.0 score on a scale | Standard Error 0.2 |
| Overall Participants | gLMS: Sweetness | Menthol Flavor | 2.1 score on a scale | Standard Error 0.2 |
| Overall Participants | gLMS: Sweetness | Tobacco Flavor | 2.0 score on a scale | Standard Error 0.3 |
Comparison: Comparison of Nicotine type.p-value: 0.39Mixed Models Analysis
Comparison: Comparison of Flavor type.p-value: 0.77Mixed Models Analysis
Secondary
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.
Time frame: up to 3 weeks
Population: Participants that enrolled and participated in the overall study.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Participants | Number of Puffs | Nicotine Salt | 2.1 number of puffs (log transformed) | Standard Error 0.2 |
| Overall Participants | Number of Puffs | Freebase Nicotine | 1.7 number of puffs (log transformed) | Standard Error 0.2 |
| Overall Participants | Number of Puffs | Menthol Flavor | 2.1 number of puffs (log transformed) | Standard Error 0.2 |
| Overall Participants | Number of Puffs | Tobacco Flavor | 1.8 number of puffs (log transformed) | Standard Error 0.2 |
Comparison: Comparison of Nicotine type.p-value: 0.01Mixed Models Analysis
Comparison: Comparison of Flavor type.p-value: 0.38Mixed Models Analysis