Evaluating the Comparative Pharmacokinetics of Nicotine After Administration Via JUUL or Tobacco Cigarettes

Open to people ages 21-70

• Healthy on the basis of medical history and limited physical examination, as described below:
• • Heart rate < 105 beats per minute (bpm)
• • • Considered out of range if both machine and manual readings are above/below these thresholds.
• • Systolic Blood Pressure < 160 and > 90*
• • Diastolic Blood Pressure < 100 and > 50*
• Age: >= 21 & <=70 years old
• Body Mass Index (BMI) <= 38.0 (at PI's discretion for higher BMI if no other concurrent health issues)
• Willingness to avoid combusted marijuana up to 48 hours before each study visit
• Nicotine strength of e-liquid of usual e-cigarette > 0 mg/ml
• Group 1 Experienced E-cigarette users
• • Current use of tobacco cigarettes (<5 cigarettes per day)
• • Current e-cigarette use at least 15 days out of the past 30 days of a non-mod e-cigarette
• Group 2 Primary Tobacco cigarette users:
• • Currently smoking >= 5 cigarettes per day
• • Current e-cigarette use must be < 5 times per month
• Saliva cotinine >=50 ng/ml or urine cotinine and/or NicAlert=6
• Must have a smart phone, computer, or tablet and internet access (for remote procedures)

• Medical
• • Heart disease
• • Seizures
• • Cancer
• • Thyroid disease (okay if controlled with medication)
• • Diabetes
• • Hepatitis B or C or Liver disease
• • Glaucoma
• • Kidney disease or urinary retention
• • History of stroke
• • An ulcer in the past year
• • Active use of an inhaler for Asthma or Chronic Obstructive Pulmonary Disease (COPD)
• Psychiatric conditions
• • Current or past schizophrenia, and/or current or past bipolar disorder
• • Major depression, current or within the past year
• • Major personality disorder
• • Participants with current or past minor or moderate depression and/or anxiety disorders will be reviewed by the principal investigator (PI) and/or medical monitor and considered for inclusion
• • History of psychiatric hospitalizations are not exclusionary, but study participation will be determined as per PI's or medical monitor's approval
• Drug/Alcohol Dependence
• • Alcohol or illicit drug dependence within the past 12 months with the exception of those who have recently completed an alcohol/drug treatment program
• • Positive toxicology test for illicit drugs at the screening visit (Tetrahydrocannabinol (THC) & prescribed medications okay)
• • Opioid replacement therapy (including methadone, buprenorphine, or other)
• Psychiatric medications
• • Current regular use of any psychiatric medications is exclusionary, with the exception of Selective Serotonin Reuptake Inhibitor (SSRI) and serotonin-norepinephrine reuptake Inhibitor (SNRI) and current evaluation by the PI and/or medical monitor that the participant is otherwise healthy, stable, and able to participate
• Medications
• • Use of sympatholytic medications for cardiovascular conditions including hypertension (Example: beta and alpha-blockers)
• • Use of medications that are inducers of nicotine metabolizing enzyme CYP2A6 (Example: rifampicin, carbamazepine, phenobarbital, and other anticonvulsant drugs)
• • Concurrent use of nicotine-containing medications
• • Any stimulant medications (example: Adderall) generally given for attention deficit hyperactivity disorder (ADHD) treatment
• Use of Other Tobacco Products (OTP)
• • Any of the following products in combination more than 15 times in the past month
• • • smokeless tobacco (snus, oral snuff, chewing tobacco)
• • • pipes
• • • cigars, cigarillos, little cigars
• • • blunts, spliffs
• • • hookah
• Other/Misc. Chronic Health Conditions
• Fainting (within the last 30 days)
• Other "life threatening illnesses" as per PI's or medical monitor's discretion
• Pregnancy
• • Pregnancy (self-reported and urine pregnancy test)
• • Breastfeeding (determined by self-report)
• Concurrent participation in another clinical trial (at PI's discretion)
• Inability to read and write in English
• Planning to quit smoking or vaping within the next 60 days
• Recent onset or change (worsening) in cough, fever and/or abdominal symptoms (vomiting or pain) in the past two weeks
• Diagnosis of pneumonia in the past 3 months
• Uncomfortable with blood draws
• Known allergy to propylene glycol or vegetable glycerin