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| ID | Type | Description | Link |
|---|---|---|---|
| K01DA047433 | 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 project is to understand how different e-cigarettes influence their likeability and use among current smokers who try using e-cigarettes. Participants will receive an e-cigarette to sample over a three week period. During this time period they will complete daily electronic diaries and weekly lab visits. The results from this information will help understand how different types of e-cigarettes are likely to influence cigarette and e-cigarette use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Concentration / Low Power | Experimental | Participant will receive an e-liquid with a low nicotine concentration and an e-cigarette with a low power for three weeks. |
|
| Low Concentration / High Power | Experimental | Participant will receive an e-liquid with a low nicotine concentration and an e-cigarette with a high power for three weeks. |
|
| High Concentration / Low Power | Experimental | Participant will receive an e-liquid with a high nicotine concentration and an e-cigarette with a low power for three weeks. |
|
| High Concentration / High Power | Experimental | Participant will receive an e-liquid with a high nicotine concentration and an e-cigarette with a high power for three weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Power | Behavioral | Participants will receive a low power e-cigarette to use for 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Cigarettes Per Day | Participants complete weekly surveys reporting the number of cigarettes smoked each day on a continuous scale | Week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Average Number of E-cigarette Puffing Episodes | Participants complete weekly surveys reporting the number of e-cigarette puffing episodes each day on a continuous scale | Week 3 |
| Number of Choices to Smoke Cigarette in Lab Setting |
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Inclusion criteria include
Exclusion criteria include
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| Name | Affiliation | Role |
|---|---|---|
| Tracy Smith, PhD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Concentration / Low Power | Participant will receive an e-liquid with a low nicotine concentration and an e-cigarette with a low power for three weeks. Low Power: Participants will receive a low power e-cigarette to use for 3 weeks Low Concentration: Participants will receive a low concentration e-liquid to use for 3 weeks |
| FG001 | Low Concentration / High Power | Participant will receive an e-liquid with a low nicotine concentration and an e-cigarette with a high power for three weeks. High Power: Participants will receive a high power e-cigarette to use for 3 weeks Low Concentration: Participants will receive a low concentration e-liquid to use for 3 weeks |
| FG002 | High Concentration / Low Power | Participant will receive an e-liquid with a high nicotine concentration and an e-cigarette with a low power for three weeks. Low Power: Participants will receive a low power e-cigarette to use for 3 weeks High Concentration: Participants will receive a high concentration e-liquid to use for 3 weeks |
| FG003 | High Concentration / High Power | Participant will receive an e-liquid with a high nicotine concentration and an e-cigarette with a high power for three weeks. High Power: Participants will receive a high power e-cigarette to use for 3 weeks High Concentration: Participants will receive a high concentration e-liquid to use for 3 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Concentration / Low Power | Participant will receive an e-liquid with a low nicotine concentration and an e-cigarette with a low power for three weeks. Low Power: Participants will receive a low power e-cigarette to use for 3 weeks Low Concentration: Participants will receive a low concentration e-liquid to use for 3 weeks |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mean Cigarettes Per Day | Participants complete weekly surveys reporting the number of cigarettes smoked each day on a continuous scale | Posted | Mean | Standard Deviation | cigarettes per day | Week 3 |
|
Two months
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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 | Low Concentration / Low Power | Participant will receive an e-liquid with a low nicotine concentration and an e-cigarette with a low power for three weeks. Low Power: Participants will receive a low power e-cigarette to use for 3 weeks Low Concentration: Participants will receive a low concentration e-liquid to use for 3 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tracy Smith | Medical University of South Carolina | 8437925164 | smithtra@musc.edu |
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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 | Oct 26, 2021 | Sep 26, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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| High Power | Behavioral | Participants will receive a high power e-cigarette to use for 3 weeks |
|
| Low Concentration | Behavioral | Participants will receive a low concentration e-liquid to use for 3 weeks |
|
| High Concentration | Behavioral | Participants will receive a high concentration e-liquid to use for 3 weeks |
|
Participants complete lab-based choice task at Week 3 visit in which they choose between smoking conventional cigarette and e-cigarette over 10 trials. Outcome is number of times each participant chooses to smoke conventional cigarette.
| Week 3 |
| Low Concentration / High Power |
Participant will receive an e-liquid with a low nicotine concentration and an e-cigarette with a high power for three weeks. High Power: Participants will receive a high power e-cigarette to use for 3 weeks Low Concentration: Participants will receive a low concentration e-liquid to use for 3 weeks |
| BG002 | High Concentration / Low Power | Participant will receive an e-liquid with a high nicotine concentration and an e-cigarette with a low power for three weeks. Low Power: Participants will receive a low power e-cigarette to use for 3 weeks High Concentration: Participants will receive a high concentration e-liquid to use for 3 weeks |
| BG003 | High Concentration / High Power | Participant will receive an e-liquid with a high nicotine concentration and an e-cigarette with a high power for three weeks. High Power: Participants will receive a high power e-cigarette to use for 3 weeks High Concentration: Participants will receive a high concentration e-liquid to use for 3 weeks |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | High Concentration / Low Power | Participant will receive an e-liquid with a high nicotine concentration and an e-cigarette with a low power for three weeks. Low Power: Participants will receive a low power e-cigarette to use for 3 weeks High Concentration: Participants will receive a high concentration e-liquid to use for 3 weeks |
| OG003 | High Concentration / High Power | Participant will receive an e-liquid with a high nicotine concentration and an e-cigarette with a high power for three weeks. High Power: Participants will receive a high power e-cigarette to use for 3 weeks High Concentration: Participants will receive a high concentration e-liquid to use for 3 weeks |
|
|
| Secondary | Average Number of E-cigarette Puffing Episodes | Participants complete weekly surveys reporting the number of e-cigarette puffing episodes each day on a continuous scale | Posted | Mean | Standard Deviation | cigarettes per day | Week 3 |
|
|
|
| Secondary | Number of Choices to Smoke Cigarette in Lab Setting | Participants complete lab-based choice task at Week 3 visit in which they choose between smoking conventional cigarette and e-cigarette over 10 trials. Outcome is number of times each participant chooses to smoke conventional cigarette. | Posted | Mean | Standard Error | Events | Week 3 |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 12 |
| 23 |
| EG001 | Low Concentration / High Power | Participant will receive an e-liquid with a low nicotine concentration and an e-cigarette with a high power for three weeks. High Power: Participants will receive a high power e-cigarette to use for 3 weeks Low Concentration: Participants will receive a low concentration e-liquid to use for 3 weeks | 0 | 24 | 0 | 24 | 13 | 24 |
| EG002 | High Concentration / Low Power | Participant will receive an e-liquid with a high nicotine concentration and an e-cigarette with a low power for three weeks. Low Power: Participants will receive a low power e-cigarette to use for 3 weeks High Concentration: Participants will receive a high concentration e-liquid to use for 3 weeks | 0 | 23 | 0 | 23 | 12 | 23 |
| EG003 | High Concentration / High Power | Participant will receive an e-liquid with a high nicotine concentration and an e-cigarette with a high power for three weeks. High Power: Participants will receive a high power e-cigarette to use for 3 weeks High Concentration: Participants will receive a high concentration e-liquid to use for 3 weeks | 0 | 23 | 0 | 23 | 11 | 23 |
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Increased Phlegm | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Throat and Mouth Irritation | Gastrointestinal disorders | Systematic Assessment |
|
| Burning in the Throat | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Lung Problems | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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