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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-10267 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This clinical trial studies the effects, appeal, and abuse liability of 6-methyl nicotine (metatine) electronic cigarettes among young adults.
PRIMARY OBJECTIVES:
I. Assess the pharmacokinetics of metatine and nicotine electronic (e)-cigarettes.
II. Assess the abuse liability and appeal of commercial e-cigarettes containing metatine versus nicotine.
III. Determine the impact of metatine on e-cigarette puffing behavior (topography).
OUTLINE: Participants attend 3 sessions where they will be randomized to 1 of 3 types of e-cigarette. Participants will use the e-cigarette ad-libitum for 30 minutes and answer survey questions about their perceptions of the e-cigarette. Participants must also undergo 4 blood draws during the vaping session.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participant's personal nicotine e-cigarette | Active Comparator | The study participant's own preferred e-cigarette will be used for this condition. |
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| Nicotine e-cigarette | Active Comparator | A fruit flavored commercially available nicotine e-cigarette will be used for this condition. |
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| 6-methyl nicotine (metatine) e-cigarette | Active Comparator | A fruit flavored commercially available metatine e-cigarette will be used for this condition. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Other | Undergo blood sample collection |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of metatine and nicotine e-cigarettes | Pharmacokinetics of metatine and nicotine e-cigarettes will be examined by measuring the concentration of metatine and nicotine in blood plasma at different timepoints throughout the study vaping session. | Pre-vaping session, Minute 5 of vaping session, Minute 15 of vaping session, Minute 30 of vaping session |
| E-cigarette puffing behavior | E-cigarette puffing behavior will be measured with a topography device that records frequency, duration, and flow rate of e-cigarette puffs. These measures are combined to inform the overall measure of e-cigarette puffing behavior. | Week 1, Week 2, Week 3 |
| Sensory perceptions of EC vaping experience | Sensory perceptions of vaping will be measured by the Sensory E-cigarette Expectancies Scale (SEES) questionnaire. The SEES asks questions about sensory experiences associated with vaping on a scale from 0 (Never) - 4 (Almost Always). | Minute 5 of vaping session, Minute 30 of vaping session |
| Appeal ratings | Participants will rate appeal (e.g., liking, disliking) on Visual Analogue Scales (range, 0-100). | Minute 5 of vaping session, Minute 30 of vaping session |
| Sensory ratings | Participants will rate sensory attributes (e.g., harshness, coolness) on Visual Analogue Scales (range, 0-100). | Minute 5 of vaping session, Minute 30 of vaping session |
| Relief of withdrawal symptoms | Nicotine withdrawal relief will be measured by the Minnesota Nicotine Withdraw Scale (MNWS). The MNWS asks users how much they are currently feeling certain nicotine withdraw symptoms on a scale of None, Slight, Moderate, Mild, or Severe. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alayna P Tackett, PhD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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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 |
|---|---|
| D066300 | Electronic Nicotine Delivery Systems |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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Randomization to condition order will be completed prior to study Visit 1. Each participant will receive a randomized ordering developed using a random sequence generator.
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| Survey Administration | Other | Complete Surveys |
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| Vaping Topography | Behavioral | Use e-cigarette connected to a topography device |
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| Participant's Own Preferred E-cigarette | Other | Participant vapes their own preferred e-cigarette for 30 minutes |
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| Nicotine E-cigarette | Other | Participant vapes a commercially available nicotine e-cigarette for 30 minutes |
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| 6-methyl-nicotine (metatine) e-cigarette | Other | Participant vapes a commercially available metatine e-cigarette for 30 minutes |
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| Pre-vaping session, Minute 5 of Vaping Session, Minute 30 of vaping session |