Cardiovascular Risk FactorTCORS-1NCT03839745
Short-Term Cardiovascular Effects of E-Cigarettes: Influence of Device Power
A study testing Electronic Cigarette in people with Cardiovascular Risk Factor and Nicotine Dependence, run by University of California, San Francisco at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor, Nicotine Dependence
- What is being tested?
- Electronic Cigarette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Mar 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 beats per minute (BPM)*
- Systolic Blood Pressure < 160 and > 90*
- Diastolic Blood Pressure < 100 and > 50*
- Body Mass Index (BMI) ≤ 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
Who cannot join
- 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)
Show all 36Show fewer
- 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 attention deficit hyperactivity disorder (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 Selective Serotonin Reuptake Inhibitor (SSRI) and serotonin-norepinephrine reuptake Inhibitor (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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
University of California, San Francisco
San Francisco, California, 94143
About this study
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.
Read the 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, 15, and 20 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.
- Conditions
- Cardiovascular Risk Factor, Nicotine Dependence
- Being tested
- Electronic Cigarette
- Keywords
- E-Cigarettes, Vaping, E-Cig Mods
- Medical subject headings
- Tobacco Use Disorder, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic CigaretteOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Power level 10, 15, or 20 watts | Other | Using an electronic cigarette, the patient will participate in a standardized vaping session using 1 of 3 assigned battery power levels Receives: Other: Electronic Cigarette |
| 1 of the other 2 remaining power levels | Other | Using an electronic cigarette, the patient will participate in a standardized vaping session using 1 of the other 2 remaining power levels Receives: Other: Electronic Cigarette |
| Remaining power level | Other | Using an electronic cigarette, the patient will participate in a standardized vaping session using the remaining power level Receives: Other: Electronic Cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean nicotine levels
Concentration of plasma nicotine (ng/ml) will be used to assess differences in nicotine exposure across the three power levels.
Measured: Day 1 of each Arm
Mean scores on the Minnesota Nicotine Withdrawal Scale (MNWS)
The Minnesota Nicotine Withdrawal Scale (MNWS) is an 7-item self-report scale designed to measure the severity of craving and withdrawal symptoms experienced during smoking cessation. Each item is rated on a scale of 0 to 4 with 0=none,1= Slight, 2= Mild, 3= Moderate, and 4=Severe. Seven of the items are symptoms derived from the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) Tobacco Withdrawal diagnosis and are as follows: depression, insomnia, irritability/frustration/anger, anxiety/nervousness, difficulty concentrating, restlessness, increased appetite and at least five of the items must have responses in order to generate a reliable score. Responses to each item are summed to produce a total withdrawal summary score. The overall mean and standard deviation (SD) will be calculated with a minimum score of 0 and a maximum mean score of 28. Greater scores indicate a higher level of severity in withdrawal symptoms.
Measured: Days 1-2 of each Arm
Mean scores on the Questionnaire of Smoking Urges (QSU-Brief)
The QSU-Brief consists of 10 statements about the respondent's feelings and thoughts about participant's desire to smoke cigarettes as the participant is completing the questionnaire (i.e., right now). Each response is scored a number ranging from 1 (strongly disagree) to 7 (strongly agree) and scores are calculated by summing the item scores for a total score where a higher scores (score range from 10 points to 70 points) indicates a higher intensity of the indicated subjective effect.
Measured: Days 1-2 of each Arm
Mean scores on the modified Cigarette Evaluation Scale (mCES)
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.
Measured: Days 1-2 of each Arm
Mean differences in acrolein (3HPMA)
Mean differences in 24-hour urine mercapturic acid metabolites of VOCs, particularly 3HPMA, the metabolite of acrolein across power settings will be calculated to determine Volatile Organic Compounds (VOC) Exposure.
Measured: Day 2 of each Arm
Mean Heart Rate
Heart rate for participants will be measured in beats per minute throughout the inpatient stay as a measure of cardiovascular effects.
Measured: Days 1-3 of each Arm
Mean Blood Pressure
Participant systolic and diastolic blood pressure for participants will be taken for 24 hours during ad-lib e-cigarette use as a measure of cardiovascular effects.
Measured: Day 2 of each Arm
Proportion of participants with demonstrated epinephrine excretion
Assays will be performed on participant urine samples to measure the presence of epinephrine metabolites in the form of catecholamines in ng/ml as a measure of cardiovascular effects
Measured: Days 1-2 of each Arm
Proportion of participants with biomarkers of oxidative stress
The proportion of participants with urine samples to measuring oxidative stress-related constituents F2-isoprostane and 11-dehydrothromboxane B2 (dTXB2) in ng/ml will be calculated.
Measured: Days 1-2 of each Arm
Proportion of participants biomarkers of inflammation
The proportion of participants with blood sample results measuring cardiovascular inflammation-related constituents Interleukin 6 (IL-6), Vascular endothelial growth factor (VEGF), and Soluble intercellular adhesion molecule-1 (sICAM-1) in ng/ml will be calculated.
Measured: Day 1-2 of each Arm
Secondary outcomes (3)
Mean puffs per minute
Vaping topography measures will be obtained from frame-by-frame analysis of high-definition videos during the ad libitum sessions and calculated as mean puffs per minute.
Measured: Day 1 of each Arm
Mean puff duration
Vaping topography measures will be obtained from frame-by-frame analysis of high-definition videos during the ad libitum sessions and calculated as mean seconds per puff.
Measured: Day 1 of each Arm
Mean inter-puff interval
Vaping topography measures will be obtained from frame-by-frame analysis of high-definition videos during the ad libitum sessions and calculated as mean seconds/minutes between puffs.
Measured: Day 1 of each Arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start26 Mar 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Food and Drug Administration (FDA)
- Responsible party
- Sponsor
- Investigators
- Gideon St. Helen, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839745
- Sponsor's protocol ID
- 1723965
- Other IDs
- 5U54HL147127, NCI-2021-01564
- Acronym
- TCORS-1
- Status last verified
- Jun 2024
- First submitted
- 24 Jan 2019
- Last updated
- 1 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Cardiovascular Effects of E-Cigarettes: Influence of Device Power
- ClinicalTrials.gov ID
- NCT03839745
- Acronym / sponsor ID
- TCORS-1 / 1723965
- Conditions
- Cardiovascular Risk Factor, Nicotine Dependence
- Keywords
- E-Cigarettes, Vaping, E-Cig Mods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Food and Drug Administration (FDA)
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, 15, and 20 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Power level 10, 15, or 20 watts | Other | Other: Electronic CigaretteUsing an electronic cigarette, the patient will participate in a standardized vaping session using 1 of 3 assigned battery power levels |
| 1 of the other 2 remaining power levels | Other | Other: Electronic CigaretteUsing an electronic cigarette, the patient will participate in a standardized vaping session using 1 of the other 2 remaining power levels |
| Remaining power level | Other | Other: Electronic CigaretteUsing an electronic cigarette, the patient will participate in a standardized vaping session using the remaining power level |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 beats per minute (BPM)*
- Systolic Blood Pressure < 160 and > 90*
- Diastolic Blood Pressure < 100 and > 50*
Key exclusion criteria (36 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic CigaretteE-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. | Other | 1 of the other 2 remaining power levels, Power level 10, 15, or 20 watts, Remaining power level |
Primary outcome
Mean nicotine levels
Time frame: Day 1 of each Arm
Concentration of plasma nicotine (ng/ml) will be used to assess differences in nicotine exposure across the three power levels.
Mean scores on the Minnesota Nicotine Withdrawal Scale (MNWS)
Time frame: Days 1-2 of each Arm
The Minnesota Nicotine Withdrawal Scale (MNWS) is an 7-item self-report scale designed to measure the severity of craving and withdrawal symptoms experienced during smoking cessation. Each item is rated on a scale of 0 to 4 with 0=none,1= Slight, 2= Mild, 3= Moderate, and 4=Severe. Seven of the items are symptoms derived from the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) Tobacco Withdrawal diagnosis and are as follows: depression, insomnia, irritability/frustration/anger, anxiety/nervousness, difficulty concentrating, restlessness, increased appetite and at least five of the items must have responses in order to generate a reliable score. Responses to each item are summed to produce a total withdrawal summary score. The overall mean and standard deviation (SD) will be calculated with a minimum score of 0 and a maximum mean score of 28. Greater scores indicate a higher level of severity in withdrawal symptoms.
Mean scores on the Questionnaire of Smoking Urges (QSU-Brief)
Time frame: Days 1-2 of each Arm
The QSU-Brief consists of 10 statements about the respondent's feelings and thoughts about participant's desire to smoke cigarettes as the participant is completing the questionnaire (i.e., right now). Each response is scored a number ranging from 1 (strongly disagree) to 7 (strongly agree) and scores are calculated by summing the item scores for a total score where a higher scores (score range from 10 points to 70 points) indicates a higher intensity of the indicated subjective effect.
Mean scores on the modified Cigarette Evaluation Scale (mCES)
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.
Mean differences in acrolein (3HPMA)
Time frame: Day 2 of each Arm
Mean differences in 24-hour urine mercapturic acid metabolites of VOCs, particularly 3HPMA, the metabolite of acrolein across power settings will be calculated to determine Volatile Organic Compounds (VOC) Exposure.
Mean Heart Rate
Time frame: Days 1-3 of each Arm
Heart rate for participants will be measured in beats per minute throughout the inpatient stay as a measure of cardiovascular effects.
Mean Blood Pressure
Time frame: Day 2 of each Arm
Participant systolic and diastolic blood pressure for participants will be taken for 24 hours during ad-lib e-cigarette use as a measure of cardiovascular effects.
Proportion of participants with demonstrated 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 as a measure of cardiovascular effects
Proportion of participants with biomarkers of oxidative stress
Time frame: Days 1-2 of each Arm
The proportion of participants with urine samples to measuring oxidative stress-related constituents F2-isoprostane and 11-dehydrothromboxane B2 (dTXB2) in ng/ml will be calculated.
Proportion of participants biomarkers of inflammation
Time frame: Day 1-2 of each Arm
The proportion of participants with blood sample results measuring cardiovascular inflammation-related constituents Interleukin 6 (IL-6), Vascular endothelial growth factor (VEGF), and Soluble intercellular adhesion molecule-1 (sICAM-1) in ng/ml will be calculated.
3 secondary outcomes
Mean puffs per minute
Time frame: Day 1 of each Arm
Mean puff duration
Time frame: Day 1 of each Arm
Mean inter-puff interval
Time frame: Day 1 of each Arm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gideon St. Helen, PhD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Cigarette in people with Cardiovascular Risk Factor and Nicotine Dependence, run by University of California, San Francisco at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean nicotine levels (time frame: Day 1 of each Arm). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.