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 BPM*
• Systolic Blood Pressure < 160 and > 90*
• Diastolic Blood Pressure < 100 and > 50*

*Considered out of range if both machine and manual readings are above/below these thresholds.

• Age: ≥ 21 & ≤ 70 years old
• Body Mass Index ≤ 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 use an electronic cigarette device at least 15 days out of the past 30 days
• Group 2 Primary Tobacco cigarette users:
• Currently smoking ≥ 5 cigarettes per day
• Have tried a electronic cigarette no more than 10 times in lifetime
• Expired CO ≥ 8ppm
• Saliva cotinine ≥50 ng/ml or urine cotinine and/or NicAlert=6

• 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 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 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 (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 SSRIs and SNRIs 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 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
• Have baseline spirometry values (FEV1, FVC, and FEV1/FVC) outside of the lower limit of normal as defined in NHANES III guidelines.