Electronic Cigarettes
Conditions
Brief summary
The purpose of this research study is to find out how different types of electronic cigarettes (ECIG) settings, combined with e-liquids of differing nicotine concentrations, affect blood nicotine levels, use behavior (how users puff), and how users feel.
Interventions
OTHERECIG Lab Session 15 watts, 10 mg nicotine
During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
OTHERECIG Lab Session 15 watts, 15 mg nicotine
During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.).
OTHERECIG Lab Session 15 watts, 30 mg nicotine
During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
OTHERECIG Lab Session 30 watts, 10 mg nicotine
During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
OTHERECIG Lab Session 30 watts, 15 mg nicotine
During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
OTHERECIG Lab Session 30 watts, 30 mg nicotine
During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
Sponsors
National Institute on Drug Abuse (NIDA)
Virginia Commonwealth University
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Masking description
Participants will be blinded to the power level and nicotine concentration used in each session.
Intervention model description
The purpose of this study is to determine differences in nicotine delivery, use behavior (puff topography), carbon monoxide delivery, subjective effects, and physiological effects, when cigarette smokers and experienced electronic cigarette users use an electronic cigarette with different settings (different voltage and resistance settings, which together determine power levels) and different e-liquid concentrations.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
--participants must be: * healthy (determined by self-report) * between the ages of 18-55 * willing to provide informed consent * able to attend the lab and abstain from tobacco/nicotine as required and must agree to use designated products according to study protocol
Exclusion criteria
* Women if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening. * Individuals who weigh less than 110 pounds Some study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Plasma Nicotine | Baseline to 5 min after the start of a 10-puff product use | Change in plasma nicotine level. |
| Puff Volume | Each time the e-cigarette is used during the 10-puff use bout - 5 minutes | The average volume of each puff, in ml, during 10 puff bout. |
| Puff Duration | Each time the e-cigarette is used during the 10-puff use bout - 5 minutes | The average duration of each puff, in seconds. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | Heart rate will be measured from baseline continuously throughout the 10-puff bout - 5 minutes | Average heart rate, measured in beats per minute. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Direct Effects of Nicotine Questionnaire | Questionnaire will be administered 4 times in each each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period. | This scale is used to assess how product use makes participants feel, and consists of 10 questions that are scored 0 - 100.There are no sub-scales. Items are analyzed separately. |
| Carbon Monoxide Levels | Carbon monoxide levels will be assessed before and after product use in each approximately 4-hr session: at baseline, 5 min after the end of a 10-puff product use, and then before and after an approximately 1-hour ad lib use period. | Change in carbon monoxide levels (in parts per mission) |
| Inter Puff Interval | Inter puff interval will be measured each time the e-cigarette is used during an approximately 4 hour session: during a 5-minute 10-puff use bout, and during an approximately 90 minute ad lib use period | The time between each puff, in seconds |
| General Labeled Magnitude Scale | The General Labeled Magnitude Scale will be administered twice in each approximately 4 hour session--after a 5-minute 10 puff use bout, and after the approximately 90 minute ad lib period. | This scale measures the flavor sensation, harshness, and throat hit (in three questions that correspond to those constructs) of the e-cigarette used in each session. The scale ranges from 0 - 100, with 0 being no sensation and 100 being the strongest imaginable sensation of any kind. Each item if scored nd analyzed separately (there are no sub-scales). |
| Blood Pressure | Blood pressure will be measured from baseline continuously throughout each approximately 4-hr session | Change in blood pressure, measured in mm/hg |
| Flow Rate | Flow rate will be measured each time the e-cigarette is used during an approximately 4 hour session: during a 5-minute 10-puff use bout, and during an approximately 90 minute ad lib use period | The rate of air flow during each puff, in ml/second |
| Hughes-Hatsukami Questionnaire | Questionnaire will be administered 4 times in each each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period. | This scale is used to assess the extent to which product use reduces tobacco abstinence symptoms, and consists of 11 items scored 0 - 100, with lower scores indicating less severe symptoms. There are no sub-scales. Items are analyzed separately. |
| Direct Effects of Product Use Questionnaire | Questionnaire will be administered 2 times in each each approximately 4-hr session: 10 minutes after the start of a 10-puff use bout, and then after an approximately 1-hour ad lib use period. | This scale is used to assess how product use makes participants feel and consists of 10 questions that are scored 0 - 100. There are no sub-scales. Items are analyzed separately. |
Countries
United States
Participant flow
Recruitment details
Not-completed reason was not stored by treatment arm
Pre-assignment details
Each participant will participate in 6 sessions. Sessions differ by the tobacco product used (see study arms). The sessions are ordered by latin-square; however, session order was NOT expected to change any outcomes and order effects are not relevant to the study. Therefore all outcome data was merged and analyzed only by arm and session without regard to order.
Participants by arm
| Arm | Count |
|---|---|
| Cigarette Smokers Each participant will participate in 6 sessions. During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
Session 1: ECIG Lab Session 15 watts, 10 mg nicotine Session 2: ECIG Lab Session 15 watts, 15 mg nicotine Session 3: ECIG Lab Session 15 watts, 30 mg nicotine Session 4: ECIG Lab Session 30 watts, 10 mg nicotine Session 5: ECIG Lab Session 30 watts, 15 mg nicotine Session 6: ECIG Lab Session 30 watts, 30 mg nicotine | 12 |
| E-cigarette Users Each participant will participate in 6 sessions. During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
Session 1: ECIG Lab Session 15 watts, 10 mg nicotine Session 2: ECIG Lab Session 15 watts, 15 mg nicotine Session 3: ECIG Lab Session 15 watts, 30 mg nicotine Session 4: ECIG Lab Session 30 watts, 10 mg nicotine Session 5: ECIG Lab Session 30 watts, 15 mg nicotine Session 6: ECIG Lab Session 30 watts, 30 mg nicotine | 15 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to follow up, study stopped due to COVID-19, other reasons | 10 | 8 |
Baseline characteristics
| Characteristic | Cigarette Smokers | E-cigarette Users | 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 | 12 Participants | 15 Participants | 27 Participants |
| Age, Continuous | 33.67 years STANDARD_DEVIATION 8.74 | 25.40 years STANDARD_DEVIATION 7.94 | 29.07 years STANDARD_DEVIATION 9.15 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 2 Participants | 6 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 | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 7 Participants | 11 Participants | 18 Participants |
| Region of Enrollment United States | 12 participants | 15 participants | 27 participants |
| Sex/Gender, Customized Female | 4 Participants | 7 Participants | 11 Participants |
| Sex/Gender, Customized Male | 7 Participants | 8 Participants | 15 Participants |
| Sex/Gender, Customized Other | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 15 |
| other Total, other adverse events | 0 / 12 | 0 / 15 |
| serious Total, serious adverse events | 0 / 12 | 0 / 15 |
Outcome results
Primary
Change in Plasma Nicotine
Change in plasma nicotine level.
Time frame: Baseline to 5 min after the start of a 10-puff product use
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cigarette Smokers | Change in Plasma Nicotine | 10mg 15 Watts | 8.68 ng/ml | Standard Deviation 7.22 |
| Cigarette Smokers | Change in Plasma Nicotine | 10mg 30 Watts | 9.53 ng/ml | Standard Deviation 7.53 |
| Cigarette Smokers | Change in Plasma Nicotine | 15mg 15 Watts | 7.34 ng/ml | Standard Deviation 6.19 |
| Cigarette Smokers | Change in Plasma Nicotine | 15mg 30 Watts | 13.04 ng/ml | Standard Deviation 13.14 |
| Cigarette Smokers | Change in Plasma Nicotine | 30mg 15 Watts | 10.18 ng/ml | Standard Deviation 9.28 |
| Cigarette Smokers | Change in Plasma Nicotine | 30mg 30 Watts | 17.28 ng/ml | Standard Deviation 18.05 |
| E-cigarette Users | Change in Plasma Nicotine | 30mg 15 Watts | 20.12 ng/ml | Standard Deviation 22.4 |
| E-cigarette Users | Change in Plasma Nicotine | 10mg 15 Watts | 8.28 ng/ml | Standard Deviation 9.65 |
| E-cigarette Users | Change in Plasma Nicotine | 15mg 30 Watts | 14.04 ng/ml | Standard Deviation 12.08 |
| E-cigarette Users | Change in Plasma Nicotine | 10mg 30 Watts | 12.00 ng/ml | Standard Deviation 10.29 |
| E-cigarette Users | Change in Plasma Nicotine | 30mg 30 Watts | 22.38 ng/ml | Standard Deviation 21.04 |
| E-cigarette Users | Change in Plasma Nicotine | 15mg 15 Watts | 7.17 ng/ml | Standard Deviation 6.14 |
Primary
Puff Duration
The average duration of each puff, in seconds.
Time frame: Each time the e-cigarette is used during the 10-puff use bout - 5 minutes
Population: One participant did not have data collected for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cigarette Smokers | Puff Duration | 10 mg, 30 W | 1.97 seconds | Standard Deviation 0.65 |
| Cigarette Smokers | Puff Duration | 30 mg, 30 W | 1.58 seconds | Standard Deviation 0.45 |
| Cigarette Smokers | Puff Duration | 15 mg, 15 W | 2.59 seconds | Standard Deviation 0.53 |
| Cigarette Smokers | Puff Duration | 10 mg, 15 W | 3.04 seconds | Standard Deviation 1.01 |
| Cigarette Smokers | Puff Duration | 15 mg, 30 W | 1.65 seconds | Standard Deviation 0.43 |
| Cigarette Smokers | Puff Duration | 30 mg, 15 W | 2.44 seconds | Standard Deviation 0.83 |
| E-cigarette Users | Puff Duration | 30 mg, 30 W | 2.45 seconds | Standard Deviation 0.84 |
| E-cigarette Users | Puff Duration | 30 mg, 15 W | 3.41 seconds | Standard Deviation 1.01 |
| E-cigarette Users | Puff Duration | 10 mg, 15 W | 4.37 seconds | Standard Deviation 1.15 |
| E-cigarette Users | Puff Duration | 10 mg, 30 W | 2.83 seconds | Standard Deviation 0.71 |
| E-cigarette Users | Puff Duration | 15 mg, 15 W | 4.02 seconds | Standard Deviation 1.27 |
| E-cigarette Users | Puff Duration | 15 mg, 30 W | 2.72 seconds | Standard Deviation 1.05 |
Primary
Puff Volume
The average volume of each puff, in ml, during 10 puff bout.
Time frame: Each time the e-cigarette is used during the 10-puff use bout - 5 minutes
Population: One participant did not have data for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cigarette Smokers | Puff Volume | 10 mg, 15 Watts | 457.27 ml | Standard Deviation 223.02 |
| Cigarette Smokers | Puff Volume | 10 mg, 30 Watts | 245.11 ml | Standard Deviation 124.09 |
| Cigarette Smokers | Puff Volume | 15 mg, 15 Watts | 350.18 ml | Standard Deviation 190.97 |
| Cigarette Smokers | Puff Volume | 15 mg, 30 Watts | 217.01 ml | Standard Deviation 94.99 |
| Cigarette Smokers | Puff Volume | 30 mg, 15 Watts | 310.95 ml | Standard Deviation 199.06 |
| Cigarette Smokers | Puff Volume | 30 mg, 30 Watts | 176.32 ml | Standard Deviation 79.76 |
| E-cigarette Users | Puff Volume | 30 mg, 15 Watts | 631.23 ml | Standard Deviation 225.84 |
| E-cigarette Users | Puff Volume | 10 mg, 15 Watts | 748.34 ml | Standard Deviation 412.22 |
| E-cigarette Users | Puff Volume | 15 mg, 30 Watts | 409.56 ml | Standard Deviation 208.61 |
| E-cigarette Users | Puff Volume | 10 mg, 30 Watts | 503.43 ml | Standard Deviation 216.28 |
| E-cigarette Users | Puff Volume | 30 mg, 30 Watts | 415.85 ml | Standard Deviation 186.33 |
| E-cigarette Users | Puff Volume | 15 mg, 15 Watts | 708.62 ml | Standard Deviation 300.45 |
Secondary
Heart Rate
Average heart rate, measured in beats per minute.
Time frame: Heart rate will be measured from baseline continuously throughout the 10-puff bout - 5 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cigarette Smokers | Heart Rate | 10 mg, 15 Watts | 75.66 bpm | Standard Deviation 6.88 |
| Cigarette Smokers | Heart Rate | 10 mg, 30 Watts | 78.19 bpm | Standard Deviation 7.25 |
| Cigarette Smokers | Heart Rate | 15 mg, 15 Watts | 72.64 bpm | Standard Deviation 6.32 |
| Cigarette Smokers | Heart Rate | 15 mg, 30 Watts | 76.05 bpm | Standard Deviation 6.91 |
| Cigarette Smokers | Heart Rate | 30 mg, 15 Watts | 77.12 bpm | Standard Deviation 8.83 |
| Cigarette Smokers | Heart Rate | 30 mg, 30 Watts | 80.12 bpm | Standard Deviation 8.95 |
| E-cigarette Users | Heart Rate | 30 mg, 15 Watts | 78.56 bpm | Standard Deviation 12.67 |
| E-cigarette Users | Heart Rate | 10 mg, 15 Watts | 75.01 bpm | Standard Deviation 10.44 |
| E-cigarette Users | Heart Rate | 15 mg, 30 Watts | 80.27 bpm | Standard Deviation 12.51 |
| E-cigarette Users | Heart Rate | 10 mg, 30 Watts | 79.92 bpm | Standard Deviation 15.3 |
| E-cigarette Users | Heart Rate | 30 mg, 30 Watts | 84.51 bpm | Standard Deviation 14.79 |
| E-cigarette Users | Heart Rate | 15 mg, 15 Watts | 79.09 bpm | Standard Deviation 15.3 |
Other Pre-specified
Blood Pressure
Change in blood pressure, measured in mm/hg
Time frame: Blood pressure will be measured from baseline continuously throughout each approximately 4-hr session
Other Pre-specified
Carbon Monoxide Levels
Change in carbon monoxide levels (in parts per mission)
Time frame: Carbon monoxide levels will be assessed before and after product use in each approximately 4-hr session: at baseline, 5 min after the end of a 10-puff product use, and then before and after an approximately 1-hour ad lib use period.
Other Pre-specified
Direct Effects of Nicotine Questionnaire
This scale is used to assess how product use makes participants feel, and consists of 10 questions that are scored 0 - 100.There are no sub-scales. Items are analyzed separately.
Time frame: Questionnaire will be administered 4 times in each each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Other Pre-specified
Direct Effects of Product Use Questionnaire
This scale is used to assess how product use makes participants feel and consists of 10 questions that are scored 0 - 100. There are no sub-scales. Items are analyzed separately.
Time frame: Questionnaire will be administered 2 times in each each approximately 4-hr session: 10 minutes after the start of a 10-puff use bout, and then after an approximately 1-hour ad lib use period.
Other Pre-specified
Flow Rate
The rate of air flow during each puff, in ml/second
Time frame: Flow rate will be measured each time the e-cigarette is used during an approximately 4 hour session: during a 5-minute 10-puff use bout, and during an approximately 90 minute ad lib use period
Other Pre-specified
General Labeled Magnitude Scale
This scale measures the flavor sensation, harshness, and throat hit (in three questions that correspond to those constructs) of the e-cigarette used in each session. The scale ranges from 0 - 100, with 0 being no sensation and 100 being the strongest imaginable sensation of any kind. Each item if scored nd analyzed separately (there are no sub-scales).
Time frame: The General Labeled Magnitude Scale will be administered twice in each approximately 4 hour session--after a 5-minute 10 puff use bout, and after the approximately 90 minute ad lib period.
Other Pre-specified
Hughes-Hatsukami Questionnaire
This scale is used to assess the extent to which product use reduces tobacco abstinence symptoms, and consists of 11 items scored 0 - 100, with lower scores indicating less severe symptoms. There are no sub-scales. Items are analyzed separately.
Time frame: Questionnaire will be administered 4 times in each each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Other Pre-specified
Inter Puff Interval
The time between each puff, in seconds
Time frame: Inter puff interval will be measured each time the e-cigarette is used during an approximately 4 hour session: during a 5-minute 10-puff use bout, and during an approximately 90 minute ad lib use period