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

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ClinicalTrials.gov Identifier: NCT04053868
Recruitment Status : Not yet recruiting
First Posted : August 13, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
Nicotine Administration & Dosage E-cigarettes Vaping E-Liquid Tobacco Smoking Other: JUUL Other: Tobacco Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluating the Comparative Pharmacokinetics of Nicotine After Administration Via JUUL or Tobacco Cigarettes
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arm Intervention/treatment
Experimental: Electronic Cigarette
The participants will participate in a standardized vaping session using a JUUL E-cigarette device with a JUUL e-liquid pod.
Other: JUUL
Electronic Cigarette

Experimental: Tobacco Cigarette
The participants will participate in a standardized smoking session using commercial tobacco cigarettes.
Other: Tobacco
Tobacco Cigarette




Primary Outcome Measures :
  1. Nicotine Exposure [ Time Frame: 6 Hours ]
    Plasma nicotine AUC (ng/ml*h)


Secondary Outcome Measures :
  1. Cardiovascular Effects: Heart Rate [ Time Frame: Hospital Days 1-2 of each Arm ]
    Participant heart rate will be measured in beats per minute throughout both inpatient stays.

  2. Cardiovascular Effects: Systolic Blood Pressure [ Time Frame: Hospital Days 1-2 of each Arm ]
    Participant systolic blood pressure will be taken during e-cigarette and/or tobacco cigarette use.

  3. Cardiovascular Effects: Diastolic Blood Pressure [ Time Frame: Hospital Days 1-2 of each Arm ]
    Participant diastolic blood pressure will be taken during e-cigarette and/or tobacco cigarette use.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04053868


Contacts
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Contact: Natalie Nardone, PhD 415-514-1450 natalie.nardone@ucsf.edu
Contact: Jaime H Velasco, BA 415-706-6023 jaime.velasco@ucsf.edu

Locations
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United States, California
UCSF Tobacco Research Center Not yet recruiting
San Francisco, California, United States, 94110
Contact: Jaime H Velasco, BA    415-706-6023    jaime.velasco@ucsf.edu   
Contact: Natalie Nardone, PhD    415-514-1450    natalie.nardone@ucsf.edu   
Principal Investigator: Neal L Benowitz, MD         
Zuckerberg San Francisco General Hospital- CTSI
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Neal L Benowitz, MD University of California, San Francisco

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04053868     History of Changes
Other Study ID Numbers: 19-28309
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action