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| ID | Type | Description | Link |
|---|---|---|---|
| 2U54DA036151-06 | 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 overall goal of this proposal is to understand the relationship between nicotine metabolism and menthol flavor in e-cigarettes on smoking behavior in smokers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5% nicotine with menthol flavor and tobacco flavor | Experimental | All participants will receive 5% nicotine/menthol and 5% nicotine/tobacco e-cigarettes over the course of 2 lab sessions; the order of which flavor goes first at each lab session is counterbalanced with half getting menthol flavor first and half getting tobacco flavor first. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine | Drug | Participants will receive 5% nicotine in two flavor exposures via e-cigarettes. Each exposure will be 10 3-sec puffs |
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| Measure | Description | Time Frame |
|---|---|---|
| Plasma Nicotine Levels | Mean plasma levels obtained after e-cigarette administration at each lab session (lab 1 and lab 2). | Lab 1 (day 1) and Lab 2 (24 hour minimum / 2 week maximum from Lab 1). During each lab session, plasma levels were collected at baseline, 5, 15, 30, 45 and 60 minutes after e-cigarette exposure. |
| Nicotine Metabolic Rate | Mean Area under the curve (AUC) for plasma nicotine and NMR were computed and then log transformed to reduce skewness of the two measures. | Lab 1 (day 1) and Lab 2 (24 hour minimum / 2 week maximum from Lab 1). During each lab session, plasma levels were collected at baseline, 5, 15, 30, 45 and 60 minutes after e-cigarette exposure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Mental Health Center | New Haven | Connecticut | 06519 | United States |
All participants will be exposed to the two flavor conditions (tobacco and menthol) in a counterbalanced randomized order. Each lab session exposure will consist of 10 3-sec puffs separated by 30 second intervals and will be separated by a minimum of 24 hours and maximum of 2 weeks.
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| ID | Title | Description |
|---|---|---|
| FG000 | Menthol Flavor First, Then Tobacco Flavor | Participants were exposed to Menthol then Tobacco flavor with a 60 second washout in between. |
| FG001 | Tobacco Flavor First, Then Menthol Flavor | Participants were exposed to Tobacco then Menthol flavor with a 60 second washout in between. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Lab Session |
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| Between Sessions (2 Days up to 2 Weeks) |
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| Lab Session 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Menthol / Nicotine | All participants complete both arms described in the protocol section (menthol arm and tobacco arm). |
| 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 |
| 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 Levels | Mean plasma levels obtained after e-cigarette administration at each lab session (lab 1 and lab 2). | Outcomes from 8 participants. 10 participants completed both menthol flavor and tobacco flavor labs (5 in each arm), however the lab/blood analysis was not valid for 2 participants (one in each arm). | Posted | Mean | Standard Deviation | ng/mL | Lab 1 (day 1) and Lab 2 (24 hour minimum / 2 week maximum from Lab 1). During each lab session, plasma levels were collected at baseline, 5, 15, 30, 45 and 60 minutes after e-cigarette exposure. |
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Participant's Adverse Event data was collected from study enrollment through both lab sessions (menthol and nicotine); approximately 3 weeks.
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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 | Menthol Flavor | Participants receiving menthol flavor | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| High Blood Pressure | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Liss | Yale University | 2034447545 | thomas.liss@yale.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 | Aug 14, 2024 | Sep 5, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 9, 2023 | Jan 15, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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| Withdrawal by Subject |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | 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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Participants will receive 5% nicotine with tobacco flavor in an e-cigarette Each exposure will be 10 3-sec puffs |
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| Primary | Nicotine Metabolic Rate | Mean Area under the curve (AUC) for plasma nicotine and NMR were computed and then log transformed to reduce skewness of the two measures. | Outcomes from 8 participants; 4 in each arm. 10 participants completed both menthol flavor and tobacco flavor labs, however the lab/blood analysis was not valid for 2 participants. | Posted | Mean | Standard Deviation | ng/mL*minutes | Lab 1 (day 1) and Lab 2 (24 hour minimum / 2 week maximum from Lab 1). During each lab session, plasma levels were collected at baseline, 5, 15, 30, 45 and 60 minutes after e-cigarette exposure. |
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| 14 |
| 0 |
| 14 |
| 2 |
| 14 |
| EG001 | Tobacco Flavor | Participants receiving tobacco flavor | 0 | 14 | 0 | 14 | 0 | 14 |
| Lightheaded | Nervous system disorders | Non-systematic Assessment | Lightheaded due to blood draw. |
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| D006573 |
| Heterocyclic Compounds, 1-Ring |