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

a study on Nicotine Administration & Dosage E-cigarettes Vaping E-Liquid Smoking Cessation Tobacco

Summary

for people ages 21-70 (full criteria)
healthy people welcome
at San Francisco, California and other locations
study started
estimated completion
Neal Benowitz

Description

Summary

This is an observational, crossover design that will examine the pharmacokinetics and pharmacodynamics of impact of smoking tobacco cigarettes or vaping the JUUL electronic cigarette.

Details

The goal of this study is to better understand the pharmacokinetic and pharmacodynamics responses produced by the JUUL e-cigarette, compared to tobacco cigarettes, in e-cigarette and tobacco cigarette smokers.

Specific Aim #1- To categorize the nicotine PK profile (maximum plasma concentration; time to maximum plasma concentration and area under the concentration-time curve) and compare when using the JUUL e-cigarette vs. a tobacco cigarette in a standardized manner.

Specific Aim #2- To categorize the nicotine PK profile (maximum plasma concentration; time to maximum plasma concentration and area under the concentration-time curve) and compare when using the JUUL e-cigarette vs a tobacco cigarette when using the product ad libitum.

Specific Aim #3- To evaluate various outcomes following JUUL e-cigarette or tobacco cigarette use, both with standardized and ad lib use including: heart rate, plasma catecholamines, pulmonary function testing.

Specific Aim #4- To evaluate and compare the effects on craving, reward and satisfaction when using the JUUL e-cigarette vs. tobacco cigarette.

Keywords

Nicotine Administration & Dosage E-cigarettes Vaping E-Liquid Tobacco Smoking Nicotine JUUL Tobacco Electronic Cigarette Tobacco Cigarette

Eligibility

You can join if…

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

You CAN'T join if...

  • 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.

Locations

  • UCSF Tobacco Research Center accepting new patients
    San Francisco California 94110 United States
  • Zuckerberg San Francisco General Hospital- CTSI accepting new patients
    San Francisco California 94110 United States

Lead Scientist

  • Neal Benowitz
    Neal Benowitz has been conducting research at SFGH since 1973. His research focus is on the human pharmacology of nicotine in relation to pathogenesis of and individual differences in vulnerability to tobacco-related disease, and the use of pharmacologic data as a basis for public health policies to prevent and reduce such disease.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04053868
Study Type
Interventional
Last Updated