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| ID | Type | Description | Link |
|---|---|---|---|
| 5U54DA036105-10 | 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 study is to determine differences in nicotine delivery, use behavior, carbon monoxide delivery, subjective effects, and physiological effects, when cigarette smokers use an electronic cigarette with constant device settings and different e-liquid concentrations.
Only one arm enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experiemental | Experimental | Only one arm enrolled. ECIG Lab Session, 30 watts . During each session (intervention) participants will first complete a 10-puff product use bout, and then a 90-minute product use bout. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cigarette Smoker/ECIG users: 0 mg/ml nicotine concentration | Other | ECIG LAB SESSION: 30 watts, 0 mg/ml nicotine concentration. During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Nicotine Concentration | Blood will be taken during each session (5) to examine changes from baseline to immediately follow a ten-puff bout. There is one arm, but 4 different conditions per outcome. One subject with/ missing plasma samples was removed from analysis. | Before directed bout, after directed bout, prior to ad lib use, after ad lib use, and immediately after own brand use. |
| Cigarette/ECIG Challenge Paradigm | Subjects, following a period of abstinence, they are given a limited time to use either their own brand of cigarette or an e-cigarette. One arm enrolled and the subjects received each of the 4 conditions per outcome. | Completion of ad lib bout to use of own brand cigarette |
| Measure | Description | Time Frame |
|---|---|---|
| Puff Volume | Puff volume. | During directed bout, during ad lib bout |
| Puff Duration | Puff duration measured in seconds. | During directed bout, during ad lib bout |
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Inclusion Criteria:
Exclusion Criteria:
• Women if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening.
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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for the Study of Tobacco Products | Richmond | Virginia | 23298 | United States |
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33 were enrolled
In this single-arm study, 33 were enrolled. Participants completed four, approximately 3-hr sessions.
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| ID | Title | Description |
|---|---|---|
| FG000 | E-cig/Smokers | There was only one arm enrolled. Participants completed four, approximately 3-hr sessions throughout the study.
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| 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 | Yes | No | No | Study Protocol | Mar 30, 2023 | Dec 5, 2023 |
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The purpose of this study is to determine differences in nicotine delivery, use behavior, (puff topography), and carbon monoxide delivery, subjective effects, and physiological effects, when cigarette smokers use an electronic cigarette with constant device settings and different e-liquid concentrations. Only one arm enrolled.
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| Cigarette Smokers/ECIG users: 6 mg/ml nicotine concentration | Other | ECIG Lab Session, 30 watts, 6 mg/ml nicotine concentration. 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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| Cigarette Smokers/ECIG users: 15 mg/ml nicotine concentration | Other | ECIG Lab Session, 30 watts, 15 mg/ml nicotine concentration. 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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| Cigarette Smokers/ECIG users: 30 mg/ml nicotine concentration | Other | ECIG Lab Session, 30 watts, 30 mg/ml nicotine concentration 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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| COMPLETED |
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| NOT COMPLETED |
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Demographic information is reported for the 32 participants who completed the study. Only one arm enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cigarette Smokers/ECIG Users | Participants completed four, approximately 3-hr sessions throughout the study. |
| 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, Continuous | Only one arm enrolled. | Mean | Standard Deviation | years |
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| Sex: Female, Male | Only one arm enrolled. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Only one arm enrolled. | Count of Participants | Participants |
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| Race (NIH/OMB) | Only one arm enrolled. | Count of Participants | Participants |
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| Region of Enrollment | Only one arm enrolled. | Count of Participants | 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 | Plasma Nicotine Concentration | Blood will be taken during each session (5) to examine changes from baseline to immediately follow a ten-puff bout. There is one arm, but 4 different conditions per outcome. One subject with/ missing plasma samples was removed from analysis. | One arm enrolled and the subjects received each of the 4 conditions. 1 subject with/ missing plasma samples was removed from analysis. | Posted | Mean | Standard Deviation | mg/ml | Before directed bout, after directed bout, prior to ad lib use, after ad lib use, and immediately after own brand use. |
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| Primary | Cigarette/ECIG Challenge Paradigm | Subjects, following a period of abstinence, they are given a limited time to use either their own brand of cigarette or an e-cigarette. One arm enrolled and the subjects received each of the 4 conditions per outcome. | One arm enrolled and the subjects received each of the four conditions per outcome. | Posted | Mean | Standard Deviation | latency to puff own brand in seconds | Completion of ad lib bout to use of own brand cigarette |
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| Secondary | Puff Volume | Puff volume. | 32 subjects started the study procedures and 27 completed this study procedure. One arm enrolled and the subjects received each of the four conditions per outcome. | Posted | Mean | Standard Deviation | ml | During directed bout, during ad lib bout |
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| Secondary | Puff Duration | Puff duration measured in seconds. | 32 subjects began the study procedures, only 27 completed the study procedure. The results are reported as a single arm, 4 conditions per outcome. | Posted | Mean | Standard Deviation | seconds | During directed bout, during ad lib bout |
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Data were collected through the subjects participation during the study intervention visits, an average of 2 months.
Data were collected through the subjects participation during the study intervention visits.
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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 | Experimental | ECIG Lab Session, During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout. ECIG Lab Session, 30 watts: During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout. There was only one arm enrolled and the all of the subjects received the different concentrations in the same order | 0 | 32 | 0 | 32 | 0 | 32 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alison Breland | Virginia Commonwealth University | 804 827 3562 | abbrelan@vcu.edu |
| Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 17, 2022 | Feb 2, 2023 | ICF_000.pdf |
| ID | Term |
|---|---|
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
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| Unknown or Not Reported |
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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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| After directed bout |
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| Before ad lib use |
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| After ad lib use |
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| After own brand use |
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There was only one arm enrolled. Participants completed four, approximately 3-hr sessions throughout the study.
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| OG002 | Experimental Arm/ 15 mg Condition | There was only one arm enrolled. Participants completed four, approximately 3-hr sessions throughout the study.
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| OG003 | Experimental Arm/ 30 mg Condition | There was only one arm enrolled. Participants completed four, approximately 3-hr sessions throughout the study.
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| OG002 | Experimental Arm/ 15 mg Condition | There was only one arm enrolled. Participants completed four, approximately 3-hr sessions throughout the study.
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| OG003 | Experimental Arm/ 30 mg Condition | There was only one arm enrolled. Participants completed four, approximately 3-hr sessions throughout the study.
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| OG002 | Experimental Arm/ 15 mg Condition | There was only one arm enrolled. Participants completed four, approximately 3-hr sessions throughout the study.
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| OG003 | Experimental Arm/ 30 mg Condition | There was only one arm enrolled. Participants completed four, approximately 3-hr sessions throughout the study.
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