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| ID | Type | Description | Link |
|---|---|---|---|
| 5K01DA056494 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This study examines differences between males and females in the appeal and addiction potential of menthol flavored e-cigarettes with and without nicotine.
The goal of this protocol is to investigate how sex differences in response to menthol and nicotine influence product preference and choice. In this proposal, participants will be exposed to menthol non-nicotine and nicotine containing e-cigarettes and product preference and choice will be examined in a paradigm where a menthol nicotine-containing e-cigarette is progressively more difficult to earn, and a menthol non-nicotine e-cigarette is available at a low, fixed cost. Additionally, it will be investigated how menthol e-cigarettes with and without nicotine impact reward, appeal, and sensory effects in an initial sampling session (secondary and exploratory outcomes).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sampling Session - Lab 1 | Experimental | Participants will sample and rate three menthol flavored e-cigarettes with varying levels of nicotine. |
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| Concurrent Choice Session- Lab 2 | Experimental | Participants will make choices between two menthol e-cigarettes with different levels of nicotine. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine Level 1 (0mg/ml) | Other | Menthol with be paired with 0mg/ml nicotine in an e-cigarette |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Choices | Differences in proportion of choices for the two menthol e-cigarette for males and females in the Lab 2 preference task | For the 3 hour period of the Lab 2 preference task |
| Breakpoint | Difference in highest point of the progressive ratio schedule obtained between males and females | During the 3 hour period of the Lab 2 preference task |
| Measure | Description | Time Frame |
|---|---|---|
| Reward | Difference in scores (range: 0-100) of the Liking/Wanting Subscale of the Drug Effects Questionnaire | Immediately (~2 minutes) after e-cigarette exposures in Lab 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danielle R Davis, PhD | Contact | 2039747607 | danielle.davis@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Danielle R Davis, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale School of Medicine | New Haven | Connecticut | 06473 | United States |
Investigator may share information about the IPD and study results with other researchers in the future, but the information will be de-identified.
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The de-identified data may be made available for research purposes after study publication by contacting the PI.
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D012907 | Smoking |
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Study is a within subject design. All participants are exposed to the same three e-liquids in randomized order under double-blinded conditions in the Lab 1 sampling session. In Lab 2, two of the three e-liquids (the same two across participants) are tested in a concurrent choice session.
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Participants will test three e-cigarettes in containing varying levels of nicotine and menthol in a sampling session in Lab 1 in a double blinded randomized order. Investigator and research assistant (i.e., care provider) will know the nicotine concentrations and menthol level of the three e-cigarettes, but will be blinded to the order of presentation/participant.
For Lab 2, two of the three e-cigarettes are compared in a choice task. The participant will not know the nicotine or menthol of the e-cigarettes (but as they will be labeled the same as Lab 1, so will have prior experience with them). The investigator and research assistant will know the e-cigarettes as a function of the study design.
| Nicotine Level 2 (36mg/ml) | Other | Menthol with be paired with 36mg/ml nicotine in an e-cigarette |
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| Nicotine Level 3 (59mg/ml) | Other | Menthol with be paired with 59mg/ml nicotine in an e-cigarette |
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| D001519 |
| Behavior |