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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA057282-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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In a crossover study, experienced electronic cigarette users will vape 3 different forms of nicotine: natural (derived from tobacco), synthetic, or a 50:50 mixture of both natural and synthetic. The investigators will compare nicotine metabolism, cardiovascular effects, patterns of self-administration, and participants' feelings of craving/withdrawal and enjoyment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S-nicotine (tobacco) as the starting condition | Experimental | Participants will spend 8 hours in the hospital research ward where they will vape e-liquid containing 100% (S)-nicotine. |
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| R-nicotine (synthetic) as the starting condition | Experimental | Participants will spend 8 hours in the hospital research ward where they will vape e-liquid containing 100% (R)-nicotine. |
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| Racemic (50:50 S- and R- nicotine) as the starting condition | Experimental | Participants will spend 8 hours in the hospital research ward where they will vape e-liquid containing 50% (S)-nicotine and 50% (R)-nicotine. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (S)-Nicotine | Drug | Participants will spend 8 hours in the hospital research ward and will vape e-liquid containing 100% (S)-nicotine. They will vape following a standardized session, followed by a 4 hour abstinence period. Participants will then vape as they wish (ad libitum) for 90 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Nicotine Exposure Over Time | Plasma nicotine area under the concentrated time curve (AUC) (ng/ml*h) | Up to 7 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Amount of Nicotine Consumed Over Time | Nicotine self-administration determined by device weight change before and after use multiplied by the nicotine concentration in the e-liquid | 120 minutes |
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Inclusion Criteria:
Exclusion Criteria:
• Medications
Use of medications that are inducers of nicotine metabolizing enzyme CYP2A6 (Example: rifampicin, carbamazepine, phenobarbital, and other anticonvulsant drugs).
Use of sympatholytic medications for cardiovascular conditions including hypertension (Example: beta and alpha-blockers).
Concurrent use of nicotine-containing medications (Example: nicotine patch, lozenge, gum).
Any stimulant medications (example: Adderall) generally given for ADHD treatment.
• Pregnancy
Pregnancy (self-reported and urine pregnancy test)
Breastfeeding (determined by self-report)
Women of childbearing potential must be using an acceptable method of contraception
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Lawrence | Contact | 628-206-4204 | lisa.lawrence@ucsf.edu | |
| Armando Barraza | Contact | 510-560-4842 | armando.barraza@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Neal Benowitz, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuckerberg San Francisco General Hospital (ZSFG) | Recruiting | San Francisco | California | 94110 | United States |
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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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| ID | Term |
|---|---|
| D009538 | Nicotine |
| C024270 | nicotine 1-N-oxide |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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Within-subject, single-blinded crossover study. Participants will be randomized to the order of the 3 conditions using a Latin Square design.
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| (R)- nicotine | Drug | Participants will spend 8 hours in the hospital research ward and will vape e-liquid containing 100% (R)-nicotine. They will vape following a standardized session, followed by a 4 hour abstinence period. Participants will then vape as they wish (ad libitum) for 90 minutes. |
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| Racemic nicotine | Drug | Participants will spend 8 hours in the hospital research ward and will vape e-liquid containing 50% (R)-nicotine and 50% (S)-nicotine. They will vape following a standardized session, followed by a 4 hour abstinence period. Participants will then vape as they wish (ad libitum) for 90 minutes. |
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| D001519 |
| Behavior |
| D006573 |
| Heterocyclic Compounds, 1-Ring |