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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 cigarette/vape e-liquids with differing sweetness and forms of nicotine affect blood nicotine levels, use behavior (how people puff), and how people feel.
In this study, participants will be asked to do the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cigarette and/or e-Cigarette users | Experimental | Each participant will participate in 4 sessions. During each session, participants will first complete a 10-puff product use period with the ECIG assigned for that session, then a 30-minute ad lib product use period, and then a cigarette/e-cigarette challenge paradigm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E-cigarette with sweetness type 1 and pronation level 1 | Other | An "open system" ECIG (Kanger Sub Box Mini and/or a Kangertech Sub Box Mini tank connected to hardware and/or software to limit puff duration) set to 15 Watts, which will contain e-liquid that contains a predetermined mg/ml of nicotine and sweetness type 1 and protonation level 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma nicotine concentration | Blood will be taken multiple times in each session to examine changes in plasma nicotine concentration from baseline to after various e-cigarette or cigarette usage. | Baseline (approx 90 min after session start) to after final product usage (up to 165 min) |
| Puff volume | The volume of each puff, in ml, averaged over each product use bout. | Through the final product use (up to 165 min) |
| Puff duration | The duration of each puff, in ml, averaged over each product use bout. | Through the final product use (up to 165 min) |
| Challenge paradigm latency | The cigarette or own brand e-cigarette challenge paradigm involves giving participants a five minute period to use their own brand cigarette or e-cigarette. Researchers measure the time it takes for the participant to pick up the product. | at the end of the challenge paradigm, approx. 165 min |
| Challenge paradigm puffs | The cigarette or own brand e-cigarette challenge paradigm involves giving participants a five minute period to use their own brand cigarette or e-cigarette. Researchers measure the number of puffs the participant takes. | at the end of the challenge paradigm, approx. 165 min |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Direct Effects of Product use Questionnaires | Surveys will be completed multiple times in each session to examine changes from baseline to after specific e-cigarette or cigarette usage. This scale is used to assess how product use makes participants feel and consists of 10 questions each for e-cigarettes and cigarettes that are scored 0 - 100. There are no sub-scales. Items are analyzed separately. |
Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 23, 2026 | |
| Reset | Mar 13, 2026 | |
| Release | Apr 2, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 12, 2023 | Sep 30, 2024 |
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Each participant will participate in 5 sessions. Sessions differ by the tobacco product used (see study arms). The sessions will be ordered by latin-square; however, session order is NOT expected to change any outcomes and order effects are not relevant to the study.
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| E-cigarette with sweetness type 1 and pronation level 2 | Other | An "open system" ECIG (Kanger Sub Box Mini and/or a Kangertech Sub Box Mini tank connected to hardware and/or software to limit puff duration) set to 15 Watts, which will contain e-liquid that contains a predetermined mg/ml of nicotine and sweetness type 1 and protonation level 2. |
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| E-cigarette with sweetness type 2 and pronation level 1 | Other | An "open system" ECIG (Kanger Sub Box Mini and/or a Kangertech Sub Box Mini tank connected to hardware and/or software to limit puff duration) set to 15 Watts, which will contain e-liquid that contains a predetermined mg/ml of nicotine and sweetness type 2 and protonation level 1. |
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| E-cigarette with sweetness type 2 and pronation level 2 | Other | An "open system" ECIG (Kanger Sub Box Mini and/or a Kangertech Sub Box Mini tank connected to hardware and/or software to limit puff duration) set to 15 Watts, which will contain e-liquid that contains a predetermined mg/ml of nicotine and sweetness type 2 and protonation level 2. |
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| Baseline (approx 90 min after session start) to after final product usage (up to 185 min) |
| Change in Hughes-Hatsukami Questionnaire | Surveys will be completed multiple times in each session to examine changes from baseline to after specific e-cigarette or cigarette usage. This scale will be 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. | Baseline (approx 90 min after session start) to after final product usage (up to 185 min) |
| Change in General Labeled Magnitude Scale | Surveys will be completed multiple times in each session to examine changes from baseline to after specific e-cigarette or cigarette usage. 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 is scored and analyzed separately (there are no sub-scales). | Baseline (approx 90 min after session start) to after final product usage (up to 185 min) |
| Change in Labeled Hedonic Scale | Surveys will be completed multiple times in each session to examine changes from baseline to after specific e-cigarette or cigarette usage. This measure is related to perceptions of electronic cigarette effects (4 questions, each scored from 0 - 100). | Baseline (approx 90 min after session start) to after final product usage (up to 185 min) |
| Reset | Apr 23, 2026 |
| Release | Apr 23, 2026 |
| Reset | May 15, 2026 |
| Release | May 15, 2026 |
| Reset | Jun 11, 2026 |
| Release | Jun 11, 2026 |
| Reset | Jul 7, 2026 |
| ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 23, 2026 | Mar 13, 2026 | |||
| Apr 2, 2026 | Apr 23, 2026 | |||
| Apr 23, 2026 | May 15, 2026 | |||
| May 15, 2026 | Jun 11, 2026 | |||
| Jun 11, 2026 | Jul 7, 2026 | |||
| Jul 7, 2026 |
| ID | Term |
|---|---|
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D066300 | Electronic Nicotine Delivery Systems |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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