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Short-Term Cardiovascular Effects of E-Cigarettes: Influence of Device Power (TCORS-1)

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ClinicalTrials.gov Identifier: NCT03839745
Recruitment Status : Not yet recruiting
First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Food and Drug Administration (FDA)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
This study will examine the short-term cardiovascular (CV) effects of e-cigarette device power in a randomized, crossover clinical and behavioral pharmacology study of experienced adult e-cigarette users (N=21). The specific aim is to determine the impact of e-cigarette power on nicotine pharmacology, systemic exposure to toxic volatile organic compounds (VOCs), and short-term cardiovascular effects.

Condition or disease Intervention/treatment Phase
Cardiovascular Risk Factor Nicotine Dependence Other: Electronic Cigarette Not Applicable

Detailed Description:

This is a single-site, randomized, crossover study of experienced adult e-cigarette users to assess nicotine exposure, toxicant exposure, and the short-term CV effects of e-cigarette power. Three power levels will be assessed on all participants: 10, 35, and 70 watts.

Hypothesis 1a: Systemic nicotine exposure and subjective measures of sensation in the throat, reward, and satisfaction will increase with increasing power in the e-cigarette device.

Hypothesis 1b: Mercapturic acid metabolites of volatile organic compounds (VOCs), particularly acrolein, will increase with e-cigarette power.

Hypothesis 1c: CV effects increase with higher power, and are manifested as changes in hemodynamic parameters, hormonal release, and biomarkers of endothelial function, platelet activation, inflammation, and oxidative stress.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Short-Term Cardiovascular Effects of E-Cigarettes: Influence of Device Power
Estimated Study Start Date : February 15, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arm Intervention/treatment
Power level 10, 35, or 70 watts
Using an electronic cigarette, the patient will participate in a standardized vaping session using 1 of 3 assigned battery power levels
Other: Electronic Cigarette
E-cigarette Device: The delivery device will be a variable wattage all-in-one device with operating wattage of 7.0 - 75.0 W, which is inclusive of the three power levels we intend to study.

1 of the other 2 remaining power levels
Using an electronic cigarette, the patient will participate in a standardized vaping session using 1 of the other 2 remaining power levels
Other: Electronic Cigarette
E-cigarette Device: The delivery device will be a variable wattage all-in-one device with operating wattage of 7.0 - 75.0 W, which is inclusive of the three power levels we intend to study.

Remaining power level
Using an electronic cigarette, the patient will participate in a standardized vaping session using the remaining power level
Other: Electronic Cigarette
E-cigarette Device: The delivery device will be a variable wattage all-in-one device with operating wattage of 7.0 - 75.0 W, which is inclusive of the three power levels we intend to study.




Primary Outcome Measures :
  1. Nicotine Exposure [ Time Frame: Day 1 of each Arm ]
    Concentration of plasma nicotine (ng/ml) will be used to assess differences across the three power levels.

  2. Subjective Effects: Withdrawal [ Time Frame: Days 1-2 of each Arm ]
    We will compile a score for the subjective effect of withdrawal using the sum of points scored on the Minnesota Nicotine Withdrawal Scale (MNWS), where a higher score (score range from 0 points to 60 points) indicates a higher intensity of the indicated subjective effect.

  3. Subjective Effects: Craving [ Time Frame: Days 1-2 of each Arm ]
    We will compile a score for the subjective effect of craving using the sum of points scored in the two subscales (intention and desire to engage in smoking behavior that is anticipated as pleasant, and anticipation of relief from negative affect through smoking) of the Questionnaire of Smoking Urges (QSU-Brief), where a higher score (score range from 10 points to 70 points) indicates a higher intensity of the indicated subjective effect.

  4. Subjective Effects: Reward [ Time Frame: Days 1-2 of each Arm ]
    We will compile a score for the subjective effect of reward using the sum of points scored in the five subscales (Smoking Satisfaction - score range from 1 point to 7 points; Psychological Reward - score range from 5 points to 35 points; Aversion - score range from 2 points to 14 points; Enjoyment of Respiratory Tract Sensations - score range from 2 points to 14 points; and Craving Reduction - score range from 1 point to 7 points) of the modified Cigarette Evaluation Scale (mCES), where a higher score indicates a higher intensity of the indicated subjective effect.

  5. Volatile Organic Compounds (VOC) Exposure [ Time Frame: Day 2 of each Arm ]
    We will examine differences in 24-hour urine mercapturic acid metabolites of VOCs, particularly 3HPMA, the metabolite of acrolein across power settings

  6. 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.

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

  8. Cardiovascular Effects: Epinephrine Excretion [ Time Frame: Days 1-2 of each Arm ]
    Assays will be performed on participant urine samples to measure the presence of epinephrine metabolites in the form of catecholamines, in ng/ml.

  9. Cardiovascular Effects: Biomarkers of Oxidative Stress [ Time Frame: Days 1-2 of each Arm ]
    Assays will be performed on participant urine samples to measure oxidative stress-related constituents F2-isoprostane and 11-dTXB2 in ng/ml.

  10. Cardiovascular Effects: Biomarkers of Inflammation [ Time Frame: Day 1-2 of each Arm ]
    Assays will be performed on participant blood samples to measure cardiovascular inflammation-related constituents IL-6, VEGF, and s-ICAM in ng/ml.


Secondary Outcome Measures :
  1. Vaping Topography: Puff Number [ Time Frame: Day 1 of each Arm ]
    Vaping topography measures will be obtained from frame by frame analysis of high definition videos during the ad libitum sessions and measured as puffs per minute.

  2. Vaping Topography: Puff Duration [ Time Frame: Day 1 of each Arm ]
    Vaping topography measures will be obtained from frame by frame analysis of high definition videos during the ad libitum sessions and measured as seconds per puff.

  3. Vaping Topography: Inter-Puff Interval [ Time Frame: Day 1 of each Arm ]
    Vaping topography measures will be obtained from frame by frame analysis of high definition videos 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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Use e-cigarettes on at least 25 days in the past 30 for at least 3 months and have not used another tobacco product in the past 30 days
  • Healthy on the basis of medical history and limited physical examination (screening visit), as described below:
  • Heart rate < 105 BPM*
  • Systolic Blood Pressure < 160 and > 90*
  • Diastolic Blood Pressure < 100 and > 50*
  • Body Mass Index ≤ 38.0 (at investigator's discretion for higher BMI if no other concurrent health issues)

    *Considered out of range if both machine and manual readings are above/below these thresholds.

  • Any race/ethnicity

Exclusion Criteria:

  • Used tobacco products other than e-cigarettes in past 30 days
  • Expired carbon monoxide of over 5 ppm at screening
  • The following unstable medical conditions:
  • Heart disease
  • Uncontrolled hypertension
  • Thyroid disease (not hypo or hyper, controlled with medication)
  • Diabetes
  • Hepatitis B or C or Liver disease
  • Glaucoma
  • Prostatic hypertrophy
  • Psychiatric conditions:
  • Current or past schizophrenia, and/or current or past bipolar disorder
  • Adult onset ADHD (if being treated)
  • Participants with current or past depression and/or anxiety disorders will be reviewed by the study physician and considered for inclusion
  • Psychiatric hospitalizations are not exclusionary, but study participation will be determined as per study physician'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 at the screening visit (THC & prescribed medications okay)
  • Opioid replacement therapy
  • Positive urine cannabis is not exclusionary but participant must report use of cannabis in any form on not more than 2 times per week to be eligible
  • Psychiatric medications:
  • Current regular use of any psychiatric medications with the exception of SSRIs and SNRIs and current evaluation by the study physician 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, dexamethasone, phenobarbital, and other anticonvulsant drugs).
  • Concurrent use of nicotine-containing medications
  • Other/Misc. Chronic Health Conditions
  • Oral thrush
  • Fainting
  • Untreated thyroid disease
  • Other "life threatening illnesses" as per study physician's discretion
  • Pregnancy
  • Pregnancy (self-reported and urine pregnancy test)
  • Breastfeeding (determined by self-report)
  • Concurrent participation in another clinical trial
  • Inability to communicate in English
  • Planning to quit smoking or vaping within the next 60 days

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): NCT03839745


Contacts
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Contact: Natalie Nardone, PhD (415) 514-1450 natalie.nardone@ucsf.edu
Contact: Jennifer Ko, BS (415) 641-4788 jennifer.ko@ucsf.edu

Locations
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United States, California
UCSF Tobacco Research Center
San Francisco, California, United States, 94110
Zuckerberg San Francisco General Hospital - CTSI
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
National Institutes of Health (NIH)
Food and Drug Administration (FDA)
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Gideon St. Helen, PhD University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
Informed Consent Form  [PDF] January 17, 2019
Study Protocol  [PDF] February 4, 2019


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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03839745     History of Changes
Other Study ID Numbers: 1723965
2U54CA180890-06 ( U.S. NIH Grant/Contract )
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 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

Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders