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| ID | Type | Description | Link |
|---|---|---|---|
| U54DA036105 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cigarette smokers | Active Comparator |
| |
| Electronic cigarette users | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECIG Lab Session 15 watts, 10 mg nicotine | Other | During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Plasma Nicotine | Change in plasma nicotine level. | Baseline to 5 min after the start of a 10-puff product use |
| Puff Volume | The average volume of each puff, in ml, during 10 puff bout. | Each time the e-cigarette is used during the 10-puff use bout - 5 minutes |
| Puff Duration | The average duration of each puff, in seconds. | Each time the e-cigarette is used during the 10-puff use bout - 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate | Average heart rate, measured in beats per minute. | Heart rate will be measured from baseline continuously throughout the 10-puff bout - 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Inter Puff Interval | The time between each puff, in seconds | 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 |
| Flow Rate |
Inclusion Criteria--participants must be:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Alison Breland, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Behavioral Pharmacolgy Laboratory | Richmond | Virginia | 23298 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35696157 | Derived | Eversole A, Budd S, Karaoghlanian N, Lipato T, Eissenberg T, Breland AB. Interactive effects of protonated nicotine concentration and device power on ENDS nicotine delivery, puff topography, and subjective effects. Exp Clin Psychopharmacol. 2023 Apr;31(2):443-454. doi: 10.1037/pha0000576. Epub 2022 Jun 13. |
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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.
Not-completed reason was not stored by treatment arm
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 4, 2018 |
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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.
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Participants will be blinded to the power level and nicotine concentration used in each session.
| ECIG Lab Session 15 watts, 15 mg nicotine | Other | During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.). |
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| ECIG Lab Session 15 watts, 30 mg nicotine | Other | During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout. |
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| ECIG Lab Session 30 watts, 10 mg nicotine | Other | During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout. |
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| ECIG Lab Session 30 watts, 15 mg nicotine | Other | During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout. |
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| ECIG Lab Session 30 watts, 30 mg nicotine | Other | During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout. |
|
The rate of air flow during each puff, in ml/second |
| 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 |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| Carbon Monoxide Levels | Change in carbon monoxide levels (in parts per mission) | 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. |
| Blood Pressure | Change in blood pressure, measured in mm/hg | Blood pressure will be measured from baseline continuously throughout each approximately 4-hr session |
| 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). | 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. |
| FG001 | 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 |
| Session 1: ECIG Lab Session 15 Watts, 10 mg Nicotine |
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| Session 2: ECIG Lab Session 15 Watts, 15 mg Nicotine |
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| Session 3: ECIG Lab Session 15 Watts, 30 mg Nicotine |
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| Session 4: ECIG Lab Session 30 Watts, 10 mg Nicotine |
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| Session 5: ECIG Lab Session 30 Watts, 15 mg Nicotine |
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| Session 6: ECIG Lab Session 30 Watts, 30 mg Nicotine |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Plasma Nicotine | Change in plasma nicotine level. | Posted | Mean | Standard Deviation | ng/ml | Baseline to 5 min after the start of a 10-puff product use |
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| Primary | Puff Volume | The average volume of each puff, in ml, during 10 puff bout. | One participant did not have data for this measure. | Posted | Mean | Standard Deviation | ml | Each time the e-cigarette is used during the 10-puff use bout - 5 minutes |
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| Primary | Puff Duration | The average duration of each puff, in seconds. | One participant did not have data collected for this measure. | Posted | Mean | Standard Deviation | seconds | Each time the e-cigarette is used during the 10-puff use bout - 5 minutes |
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| Secondary | Heart Rate | Average heart rate, measured in beats per minute. | Posted | Mean | Standard Deviation | bpm | Heart rate will be measured from baseline continuously throughout the 10-puff bout - 5 minutes |
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| Other Pre-specified | Inter Puff Interval | The time between each puff, in seconds | Not Posted | 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 | Participants | |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Flow Rate | The rate of air flow during each puff, in ml/second | Not Posted | 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 | Participants | |||||||||||||||||||||||||||||||||||||||||
| 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. | Not Posted | 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. | Participants | |||||||||||||||||||||||||||||||||||||||||
| 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. | Not Posted | 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. | Participants | |||||||||||||||||||||||||||||||||||||||||
| 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. | Not Posted | 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. | Participants | |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Carbon Monoxide Levels | Change in carbon monoxide levels (in parts per mission) | Not Posted | 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. | Participants | |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Blood Pressure | Change in blood pressure, measured in mm/hg | Not Posted | Blood pressure will be measured from baseline continuously throughout each approximately 4-hr session | Participants | |||||||||||||||||||||||||||||||||||||||||
| 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). | Not Posted | 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. | Participants |
During each of 6 approximately 4-hour session over up to a 3 week period.
This study did not have any SAEs or all-cause mortality.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 12 | 0 | 12 | 0 | 12 |
| EG001 | 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 | 0 | 15 | 0 | 15 | 0 | 15 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alison Breland | Virginia Commonwealth University | 804 628 2300 | abbrelan@vcu.edu |
| Mar 4, 2021 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 17, 2020 | Sep 3, 2020 | ICF_000.pdf |
| ID | Term |
|---|---|
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| >=65 years |
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| Male |
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| Other |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 15mg 15 Watts |
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| 15mg 30 Watts |
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| 30mg 15 Watts |
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| 30mg 30 Watts |
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