Eligibility Details:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
common.study.methods.has-drugs-no
common.study.methods.is-healthy-no
