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| ID | Type | Description | Link |
|---|---|---|---|
| 1K01DA056494-01 | 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 primary objective is to examine the influence of sex on sensory effects, appeal, and reinforcing value of nicotine containing e-cigs in popular flavor components; sweet and cooling.
This study looks at the effect of sex on the sensory effects of flavor components in e-cigarettes. Regular combustible tobacco users will sample 3 different flavored e-cigarettes containing nicotine in a human lab paradigm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental E-Liquid Order "A" | Experimental | All participants will be given all e-liquids (i.e. 3 flavor conditions all containing nicotine) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across 3 visits). |
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| Experimental E-Liquid Order "B" | Experimental | All participants will be given all e-liquids (i.e. 3 flavor conditions all containing nicotine) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across 3 visits). |
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| Experimental E-Liquid Order "C" | Experimental | All participants will be given all e-liquids (i.e. 3 flavor conditions all containing nicotine) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across 3 visits). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E-liquid Flavor 1 | Other | E-liquid containing 36mg/ml pronated nicotine will be administered with sweet e-cigarette flavor. |
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| Measure | Description | Time Frame |
|---|---|---|
| Appeal | Change in appeal at each flavor as measured by the computerized Labeled Hedonic Scale (LHS). Participants will self-report their responses using a computer mouse to indicate where on the scale response falls. The Labeled Hedonic Scale (LHS) is a bipolar category ratio scale that ranges from -100 (most disliked) to 100 (most liked), with 'neither liked nor disliked' as midpoint. | immediately after intervention, up to 15 minutes |
| Sensory Effects | Change in sweetness, coolness, irritation, and bitterness at each flavor as measured by the computerized Generalized Labeled Magnitude Scale (gLMS). Participants will self-report their responses using a computer mouse to indicate where on the scale response falls. The Generalized Labeled Magnitude Scales (gLMS) are category ratio scales with seven semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically as per empirically determined semantic magnitudes on a 0-100 scale (strongest imaginable at the 100 end). | immediately after intervention, up to 15 minutes |
| Reinforcing Efficacy | Change in reinforcing value at each flavor. Participants will use the multiple choice procedure to self-report their responses using a computer mouse to indicate where on the scale response falls. Following each puffing bout, participants will be asked to make discrete hypothetical choices between 10-puffs of the e-cig they had just used or a series of 44 monetary values ($0.25-$15.06). The minimum monetary value at which money is chosen over the e-cig puffs is a contingency-based estimate of e-cig value. At the end of each lab session, participants will be given a choice between another 10 e-cig puffs or one of the monetary amounts they picked in the Multiple Choice Procedures completed earlier. | immediately after intervention, up to 15 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Danielle Davis | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Mental Health Center | New Haven | Connecticut | 06519 | United States |
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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 | Jan 27, 2025 | Jan 15, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D000072137 | Vaping |
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D012907 | Smoking |
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Within subject design, all participants will receive all flavors
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Double blind, both participant and investigator will be blind to e-liquid being administered
| E-liquid Flavor 2 | Other | E-liquid containing 36mg/ml pronated nicotine will be administered with cooling e-cigarette flavor. |
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| E-liquid Flavor 3 | Other | E-liquid containing 36mg/ml pronated nicotine will be administered with unflavored e-cigarette flavor. |
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| D001519 |
| Behavior |
| D000073869 | Tobacco Smoking |
| D064424 | Tobacco Use |