Tobacco Use Disorder
Conditions
Keywords
tobacco, e-cigarette
Brief summary
The study is a randomized crossover trial. Current menthol smokers will complete a session with each flavor of an electronic cigarette: menthol and tobacco. The objective of this survey is to assess for flavor preference.
Detailed description
Participants who report typically smoking menthol cigarettes will be invited to complete a session. Participants will undergo overnight tobacco/nicotine abstinence before the visit (eCO\<12ppm). Participants will then be randomized 1:1 to e-cigarette flavor order (tobacco e-cigarette, menthol e-cigarette). They will complete a 30-minute ad libitum session with the first product, based on randomization, followed by a 1.5 hour standard washout period, followed by a 30-minute ad libitum vaping session with the second product. Throughout each session, puff topography will be measured via a pressure sensor attached to the e-cigarette device. Participants will complete self-report measures of smoking urges and withdrawal symptoms pre- and post-vaping session. In addition, they will complete measures of subjective vaping experience, perceptions of flavor, product demand, and intentions for future use.
Interventions
DEVICEE-cigarette product
Participants will be randomized 1:1 to e-cigarette flavor order either: 1. tobacco e-cigarette 2. menthol e-cigarette
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Participants will then be randomized 1:1 to e-cigarette flavor order (tobacco e-cigarette, menthol e-cigarette). They will complete a 30-minute ad libitum session with the first product, based on randomization, followed by a 1.5 hour standard washout period, followed by a 30-minute ad libitum vaping session with the second product.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* typically smoking menthol cigarettes * Non-Hispanic African American or white/Caucasian, * ≥21 years old, smoke 5-30 cigarettes per day, * daily cigarette smoker * smoked at current rate for at least 6 months * interested in trying e-cigarettes * not interested in or unable/unwilling to quit cigarette smoking * willing to complete one in-person study visits
Exclusion criteria
* Interested in quitting cigarettes in the next 30 days * use of smoking cessation pharmacotherapy in the past 30 days * use of non-cigarette tobacco products in the past 30 days * use of e-cigarettes \>5x in lifetime * use of e-cigarettes ≥4 of the past 30 days * weight \< 110 lbs * uncontrolled hypertension (systolic BP ≥ 180 or diastolic BP ≥ 105) * pregnant, plans to become pregnant, or breastfeeding * live \>10 miles from study site (Fairway CRU) * current enrollment is a research study or program that aims to alter tobacco use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire Scale Intentions for Future Use | during the intervention | Using the questionnaire scale Intentions for Future Use How much each participant intends to use the products in the future. Scale: Think about the product you just used. If this was the only flavor available, how likely would you be to try this flavor again? 1. Extremely unlikely 2. Unlikely 3. Neutral 4. Likely 5. Extremely likely The range of observed responses from participants for both groups was 1-5. Not all participants completed all study measures so the number of respondents is lower than enrolled. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire Scale Subjective Vaping Experience | during the intervention | Please indicate how you are feeling right now on a scale from 0 to 100 where 0 is not at all and 100 is extremely. How pleasant would the e-cigarette be to use right now? The observed range of responses from participants for both arms was 0 to 100. Not all participants completed all study measures so the number of respondents is lower than enrolled. |
| Questionnaire Scale Perceptions of Flavor | during the intervention | On a scale from 0 to 100 where 0 is not at all and 100 is extremely, to what extent did you like the flavor you just used? The observed range of responses from participants in both arms was from 0 to 100. Not all participants completed all study measures so the number of respondents is lower than enrolled. |
| Questionnaire Scale Product Demand | during the intervention | On a scale from 0 to 100 where 0 is not at all and 100 is extremely, how willing would you be to use the flavor you just used again in the future? The observed range of responses from participants in both arms was from 0 to 100. Not all participants completed all study measures so the number of respondents is lower than enrolled. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tobacco Then Menthol A 30-minute session with tobacco flavor then a 30-min session with menthol flavor
E-cigarette product: Participants will be randomized 1:1 to e-cigarette flavor order either:
1. tobacco e-cigarette
2. menthol e-cigarette | 28 |
| Menthol Then Tobacco A 30-minute session with menthol flavor then a 30-min session with tobacco flavor
E-cigarette product: Participants will be randomized 1:1 to e-cigarette flavor order either:
1. tobacco e-cigarette
2. menthol e-cigarette | 24 |
| Total | 52 |
Baseline characteristics
| Characteristic | Tobacco Then Menthol | Total | Menthol Then Tobacco |
|---|---|---|---|
| Age, Continuous | 54.0 years | 55 years | 56.0 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 52 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 25 Participants | 46 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 6 Participants | 3 Participants |
| Region of Enrollment United States | 28 participants | 52 participants | 24 participants |
| Sex: Female, Male Female | 12 Participants | 22 Participants | 10 Participants |
| Sex: Female, Male Male | 16 Participants | 30 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 52 |
| other Total, other adverse events | 0 / 52 | 0 / 52 |
| serious Total, serious adverse events | 0 / 52 | 0 / 52 |
Outcome results
Primary
Questionnaire Scale Intentions for Future Use
Using the questionnaire scale Intentions for Future Use How much each participant intends to use the products in the future. Scale: Think about the product you just used. If this was the only flavor available, how likely would you be to try this flavor again? 1. Extremely unlikely 2. Unlikely 3. Neutral 4. Likely 5. Extremely likely The range of observed responses from participants for both groups was 1-5. Not all participants completed all study measures so the number of respondents is lower than enrolled.
Time frame: during the intervention
Population: Participants who participated in the study
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tobacco | Questionnaire Scale Intentions for Future Use | 3.1 units on a scale |
| Menthol | Questionnaire Scale Intentions for Future Use | 3.7 units on a scale |
Secondary
Questionnaire Scale Perceptions of Flavor
On a scale from 0 to 100 where 0 is not at all and 100 is extremely, to what extent did you like the flavor you just used? The observed range of responses from participants in both arms was from 0 to 100. Not all participants completed all study measures so the number of respondents is lower than enrolled.
Time frame: during the intervention
Population: Participants who participated in the study.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tobacco | Questionnaire Scale Perceptions of Flavor | 34.0 units on a scale |
| Menthol | Questionnaire Scale Perceptions of Flavor | 51.0 units on a scale |
Secondary
Questionnaire Scale Product Demand
On a scale from 0 to 100 where 0 is not at all and 100 is extremely, how willing would you be to use the flavor you just used again in the future? The observed range of responses from participants in both arms was from 0 to 100. Not all participants completed all study measures so the number of respondents is lower than enrolled.
Time frame: during the intervention
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tobacco | Questionnaire Scale Product Demand | 38.7 units on a scale |
| Menthol | Questionnaire Scale Product Demand | 49.7 units on a scale |
Secondary
Questionnaire Scale Subjective Vaping Experience
Please indicate how you are feeling right now on a scale from 0 to 100 where 0 is not at all and 100 is extremely. How pleasant would the e-cigarette be to use right now? The observed range of responses from participants for both arms was 0 to 100. Not all participants completed all study measures so the number of respondents is lower than enrolled.
Time frame: during the intervention
Population: Participants who participated in the study
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tobacco | Questionnaire Scale Subjective Vaping Experience | 38.0 units on a scale |
| Menthol | Questionnaire Scale Subjective Vaping Experience | 48.1 units on a scale |