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This study is to examine if inhaled doses of an e-cigarette flavor, alone and in combination with menthol, changes the appeal of e-cigarettes containing low and high doses of nicotine. The hypothesis is that menthol and the other experimental flavor will interact with nicotine dose to improve taste and liking for e-cigarettes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E-cigarette flavor | Experimental | In this arm, subjects will receive an experimental flavor. Participants will be randomly assigned to low or high dose of nicotine. |
|
| Menthol Flavor | Experimental | In this arm, subjects will receive a menthol flavor. Participants will be randomly assigned to low or high dose of nicotine. |
|
| No Flavor | Placebo Comparator | In this arm, subjects will receive no flavor. Participants will be randomly assigned to low or high dose of nicotine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine | Drug | Participants will receive low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change score in Liking/wanting of the e-cigarette | The Drug Effects Questionnaire (Soria et al) will be used to ask about liking and wanting during the lab session | Baseline (+10 minutes) to end of lab session (+40 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Change score in rating of coolness | gMLS rating of e-cigarette coolness | Baseline (+10 minutes) to end of lab session (+40 minutes) |
| Change score in rating of harshness/irritation | gMLS rating of e-cigarette harshness/irritation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dana Cavallo, Ph.D. | Yale University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMHC, Substance Abuse Center | New Haven | Connecticut | 06519 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32297782 | Derived | Jackson A, Green B, Erythropel HC, Kong G, Cavallo DA, Eid T, Gueorguieva R, Buta E, O'Malley SS, Krishnan-Sarin S. Influence of menthol and green apple e-liquids containing different nicotine concentrations among youth e-cigarette users. Exp Clin Psychopharmacol. 2021 Aug;29(4):355-365. doi: 10.1037/pha0000368. Epub 2020 Apr 16. |
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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 |
| D008610 | Menthol |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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| Experimental Flavor | Other | Experimental fruit flavored e-cigarette for lab session |
|
| Menthol Flavor | Other | Menthol flavored e-cigarette for lab session |
|
| Baseline (+10 minutes) to end of lab session (+40 minutes) |
| Change score in rating of sweetness | gMLS rating of e-cigarette sweetness | Baseline (+10 minutes) to end of lab session (+40 minutes) |
| Change score in rating of sourness | gMLS rating of e-cigarette sourness | End of lab session (+40 minutes) |
| Change score in rating of fruitiness | gMLS rating of e-cigarette fruitiness | Baseline (+10 minutes) to end of lab session (+40 minutes) |
| Change score in rating of total sensation | gMLS rating of e-cigarette total sensation | Baseline (+10 minutes) to end of lab session (+40 minutes) |
| E-cigarette value | Value of e-cigarette as determined by the Multiple Choice Questionnaire (MCP) task | Baseline (+10 minutes) to end of lab session (+40 minutes) |
| Number of puffs | Number of puffs taken at the end of the ad-lib vaping period | End of ad-lib lab session 4 (+40 minutes) |
| Change score in Tobacco Craving | The Brief Questionnaire on Smoking Urges (Tiffany & Drobes,1991) will be used to assess the magnitude of change in tobacco craving during the lab session | Baseline (+10 minutes) to end of lab session (+40 minutes) |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000081005 | Cyclohexane Monoterpenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D039821 | Monoterpenes |
| D013729 | Terpenes |
| D008055 | Lipids |