Study Results
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View full resultsBasic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2021-09-22
2022-09-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Vaping to Control Group
Participants in this arm will undergo the vaping condition during the first visit and the control condition during the second visit.
Vaping condition
Participants will be asked to use a JUUL device to vape 20 puffs over 20 minutes. Participants will use JUUL pods with \~5% nicotine by weight. The anticipated amount of nicotine that will be absorbed with 20 puffs is approximately 1.6 mg, which is equal to approximately 1.5 cigarettes.
Control condition
Participants will have access to an uncharged JUUL device with an empty pod for 20 minutes.
Control to Vaping Group
Participants in this arm will undergo the control condition during the first visit and the vaping condition during the second visit.
Vaping condition
Participants will be asked to use a JUUL device to vape 20 puffs over 20 minutes. Participants will use JUUL pods with \~5% nicotine by weight. The anticipated amount of nicotine that will be absorbed with 20 puffs is approximately 1.6 mg, which is equal to approximately 1.5 cigarettes.
Control condition
Participants will have access to an uncharged JUUL device with an empty pod for 20 minutes.
Interventions
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Vaping condition
Participants will be asked to use a JUUL device to vape 20 puffs over 20 minutes. Participants will use JUUL pods with \~5% nicotine by weight. The anticipated amount of nicotine that will be absorbed with 20 puffs is approximately 1.6 mg, which is equal to approximately 1.5 cigarettes.
Control condition
Participants will have access to an uncharged JUUL device with an empty pod for 20 minutes.
Eligibility Criteria
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Inclusion Criteria
* Reports either everyday e-cigarette use with liquid containing at least 0.3% (\~3 mg/ml) nicotine or some day e-cigarette use ( at least 3 days a week) with liquid containing at least 3% (\~30 mg/ml) nicotine for the past 30 days.
Exclusion Criteria
* being unwilling to take 20 puffs from a JUUL device containing a 5% nicotine pod
* self-reported current, diagnosed medical condition(s) will be excluded automatically: heart-related conditions (e.g., recent heart attack/stroke, coronary heart disease), severe immune system disorders (e.g., HIV/AIDS, multiple sclerosis), respiratory disorders (e.g., COPD, asthma), kidney diseases, liver diseases (e.g., cirrhosis), or seizures
* observed high blood pressure at screening (systolic \>140; diastolic \>90)
* other self-reported current, diagnosed medical conditions (e.g., specific food allergies, diabetes, thyroid disease, lyme disease) will be considered for exclusion after consultation with the PI and medical monitor
* self-reported current, diagnosed psychiatric conditions or who report current psychiatric treatment or psychotropic medication use
* past month use of cocaine, opioids, benzodiazepines, methamphetamine, or other (non-cannabis) illicit drugs
* self-report of \>25 days out of the past 30 for alcohol use or \>20 days out of the past 30 for cannabis use.
* women who are breast-feeding or test positive for pregnancy (by urinalysis at screening)
* women using progestin-IUDS for birth control
* women using birth control injections (e.g., Depo-Provera)
* women who received a hysterectomy and still have ovaries present
* self-report intending to quit tobacco/nicotine products in the next 30 days
18 Years
65 Years
ALL
Yes
Sponsors
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Pennington Biomedical Research Center
OTHER
National Institute on Drug Abuse (NIDA)
NIH
Virginia Commonwealth University
OTHER
Responsible Party
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Principal Investigators
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Caroline Cobb (Amey), PhD
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Locations
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Center for the Study of Tobacco Products
Richmond, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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2019-066-PBRC
Identifier Type: OTHER
Identifier Source: secondary_id
HM20018382
Identifier Type: -
Identifier Source: org_study_id