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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04053868
Recruitment Status : Recruiting
First Posted : August 13, 2019
Last Update Posted : May 4, 2022
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
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 pharmacokinetic (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(AUC)) 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
Actual Study Start Date : December 9, 2019
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 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 area under the concentrated time curve (AUC) (ng/ml*h)


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

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

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



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 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)

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 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

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: Lisa Lawrence 415-608-4864 Lisa.Lawrence@ucsf.edu
Contact: Jeremy P Giberson 415-706-6023 jeremy.giberson@ucsf.edu

Locations
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United States, California
Zuckerberg San Francisco General Hospital Recruiting
San Francisco, California, United States, 94110
Contact: Jeremy P Giberson, BS    415-706-6023    jeremy.giberson@ucsf.edu   
Contact: Sundos Yassin, BS    (628) 206-8955    sundos.yassin@ucsf.edu   
Principal Investigator: Neal L Benowitz, MD         
Sub-Investigator: Gideon St. Helen, PhD         
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Jeremy P Giberson, BS    415-706-6023    jeremy.giberson@ucsf.edu   
Contact: Sundos Yassin    (628) 206-8955    sundos.yassin@ucsf.edu   
Principal Investigator: Neal L Benowitz, MD         
Sub-Investigator: Gideon St. Helen, PhD         
Sponsors and Collaborators
University of California, San Francisco
National Institute on Drug Abuse (NIDA)
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    
Other Study ID Numbers: 19-28309
2R01DA039264-04A1 ( U.S. NIH Grant/Contract )
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: May 4, 2022
Last Verified: May 2022
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