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Vaping High vs. Low Nicotine E-Liquid

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ClinicalTrials.gov Identifier: NCT04047836
Recruitment Status : Not yet recruiting
First Posted : August 7, 2019
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
This study will examine the effects of electronic cigarette e-liquid nicotine content in a randomized, crossover clinical and behavioral pharmacology study of experienced adult e-cigarette users (N=36). The specific aim is to determine the impact of nicotine content of e-liquid on nicotine pharmacology, systemic exposure to toxic volatile organic compounds, and short-term cardiovascular effects.

Condition or disease Intervention/treatment Phase
Cardiovascular Risk Factor Nicotine Dependence Other: Low Nicotine E-Liquid Other: Medium or High Nicotine E-Liquid Not Applicable

Detailed Description:

This is a within-subjects, crossover design of advanced electronic cigarette users in which we will examine nicotine pharmacokinetics, subjective effects, daily nicotine intake and nicotine titration, short-term cardiovascular effects, and toxicant exposure when participants are using low vs. high nicotine e-liquids.

Hypothesis 1: E-cigarette users will titrate their intake of nicotine such that they will inhale fewer aerosol toxicants and suffer less harm to health when using higher vs. lower nicotine content e-liquids.

Hypothesis 2: Compared to low nicotine, high nicotine e-liquid use will have similar cardiovascular effects throughout the day (due to compensatory behavioral changes), with similar effects on heart rate, blood pressure, and catecholamine release.

Hypothesis 3: Exposure to volatile organic compounds (VOCs) will be lower when vaping high nicotine e-liquids compared to low nicotine e-liquids.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Vaping High vs. Low Nicotine E-Liquid
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Low Nicotine
Using an electronic cigarette, the patient will participate in a standardized vaping session using 3 mg/ml nicotine e-liquid.
Other: Low Nicotine E-Liquid
Participants will vape e-liquid with nicotine concentration of 3 mg/ml.

Medium or High Nicotine
The patient will participate in a standardized vaping session using either an electronic cigarette with 18 mg/ml nicotine e-liquid or a JUUL device with a JUUL e-liquid pod.
Other: Medium or High Nicotine E-Liquid
Participants will vape either e-liquid with nicotine concentration of 18 mg/ml or a JUUL device with JUUL pod of 59 mg/ml nicotine e-liquid.




Primary Outcome Measures :
  1. Nicotine Exposure [ Time Frame: Day 1 of each Arm ]
    Plasma nicotine AUC (ng/ml*h)

  2. Cardiovascular Effects: Heart Rate [ Time Frame: Days 1-3 of each Arm ]
    Participant heart rate will be measured in beats per minute throughout the inpatient stay.

  3. Cardiovascular Effects: Systolic Blood Pressure [ Time Frame: Day 2 of each Arm ]
    Participant systolic blood pressure will be taken for 24 hours during ad-lib e-cigarette use.

  4. Cardiovascular Effects: Diastolic Blood Pressure [ Time Frame: Day 2 of each Arm ]
    Participant diastolic blood pressure will be taken for 24 hours during ad-lib e-cigarette use.


Secondary Outcome Measures :
  1. Vaping Topography: Puff Number [ Time Frame: Days 1-3 of each Arm ]
    Vaping topography measures will be obtained from self-reported participant vaping log during the ad libitum sessions and measured as puffs per minute.

  2. Vaping Topography: Puff Duration [ Time Frame: Days 1-3 of each Arm ]
    Vaping topography measures will be obtained from self-reported participant vaping log during the ad libitum sessions and measured as seconds per puff.

  3. Vaping Topography: Inter-Puff Interval [ Time Frame: Days 1-3 of each Arm ]
    Vaping topography measures will be obtained from self-reported participant vaping log during the ad libitum sessions and measured as seconds/minutes between puffs.



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 years
  • Age: ≤ 70 years
  • Current regular user of open tank EC (at least 20 times in the past 30 days) with e-liquid nicotine of 3-6 mg/mL.
  • Non-smoker or non-daily cigarette smokers agreeing to abstain from cigarettes for the duration of the study.
  • Saliva cotinine >50 ng/mL and/or NicAlert=6
  • Carbon monoxide ≥ 5 ppm or per discretion of Principal Investigator

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 considered for inclusion
  • History of psychiatric hospitalizations is not exclusionary, but study participation will be determined as per PI'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 with the exception of SSRIs and SNRIs and current evaluation by the PI that the participant is otherwise healthy, stable, and able to participate.
  • Medications
  • Use of medications that are inducers of nicotine metabolizing enzyme CYP2A6 (Example: rifampicin, carbamazepine, phenobarbital, and other anticonvulsant drugs).
  • Use of sympatholytic medications for cardiovascular conditions including hypertension (Example: beta and alpha-blockers)
  • Concurrent use of nicotine-containing medications
  • Any stimulant medications (example: Adderall) generally given for ADHD treatment
  • Other/Misc. Chronic Health Conditions
  • Oral thrush
  • Fainting (within the last 30 days)
  • Other "life threatening illnesses" as per PI's discretion
  • Pregnancy
  • Pregnancy (self-reported and urine pregnancy test)
  • Breastfeeding (determined by self-report)
  • Concurrent participation in another clinical trial
  • Inability to read and write in English
  • Planning to quit vaping within the next 60 days
  • Concurrent regular use of marijuana (occasional users of these products may be enrolled if they agree to abstain from their use during the period of the study)
  • Use of other tobacco products, smokeless tobacco, pipes, cigars/cigarillos, blunts/spliffs (no more than 10 times in the past month and must agree to abstain from their use during the period of the study)

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): NCT04047836


Contacts
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Contact: Natalie Nardone, PhD 415-514-1450 natalie.nardone@ucsf.edu
Contact: Ella Gambel, BS 415-608-3419 elizabeth.gambel@ucsf.edu

Locations
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United States, California
UCSF Tobacco Research Center Not yet recruiting
San Francisco, California, United States, 94110
Contact: Ella Gambel, BS    415-608-3419    elizabeth.gambel@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 Benowitz, MD University of California, San Francisco

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04047836     History of Changes
Other Study ID Numbers: 19-27571
First Posted: August 7, 2019    Key Record Dates
Last Update Posted: August 7, 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
Keywords provided by University of California, San Francisco:
E-Cigarettes
Vaping
E-Cig Mods
E-Liquid
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
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