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Cardiovascular Risk FactorNCT04047836

Vaping High vs. Low Nicotine E-Liquid

A study testing Low Nicotine E-Liquid and Medium or High Nicotine E-Liquid in people with Cardiovascular Risk Factor and Nicotine Dependence, run by University of California, San Francisco at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 21 to 70 yearsHealthy volunteers can take part
What is being tested?
Low Nicotine E-Liquid and Medium or High Nicotine E-Liquid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesUnited States
Study dates
1 Jun 2023to 31 Dec 2023
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 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy on the basis of medical history and limited physical examination, as described below:
  • Heart rate < 105 beats per minute (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
Show all 11Show fewer
  • Age: <= 70 years
  • Current regular user of open tank electronic cigarette (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

Who cannot join

  • Medical
  • Heart disease
  • Seizures
  • Cancer
  • Thyroid disease (okay if controlled with medication)
  • Diabetes
Show all 41Show fewer
  • 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 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 Selective Serotonin Reuptake Inhibitors (SSRIs) and serotonin-norepinephrine reuptake Inhibitors (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 attention deficit hyperactivity disorder (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)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of California, San Francisco

    San Francisco, California, 94110

  • Zuckerberg San Francisco General Hospital

    San Francisco, California, 94110

Other trials in United States

About this study

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.

Read the 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.

Being tested
Low Nicotine E-Liquid, Medium or High Nicotine E-Liquid
Keywords
E-Cigarettes, Vaping, E-Cig Mods, E-Liquid
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.

  • Low Nicotine E-LiquidOther

    Participants will vape e-liquid with nicotine concentration of 3 mg/ml.

  • Medium or High Nicotine E-LiquidOther

    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.

Study groups in NCT04047836
Study groupRoleWhat they receive
Low NicotineOtherUsing an electronic cigarette, the patient will participate in a standardized vaping session using 3 mg/ml nicotine e-liquid.
Receives: Other: Low Nicotine E-Liquid
Medium or High NicotineOtherThe 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.
Receives: Other: Medium or High Nicotine E-Liquid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nicotine Exposure

    Plasma nicotine area under curve (AUC) (ng/ml*h)

    Measured: Day 1 of each Arm

  2. Cardiovascular Effects: Heart Rate

    Participant heart rate will be measured in beats per minute throughout the inpatient stay.

    Measured: Days 1-3 of each Arm

  3. Cardiovascular Effects: Systolic Blood Pressure

    Participant systolic blood pressure will be taken for 24 hours during ad-lib e-cigarette use.

    Measured: Day 2 of each Arm

  4. Cardiovascular Effects: Diastolic Blood Pressure

    Participant diastolic blood pressure will be taken for 24 hours during ad-lib e-cigarette use.

    Measured: Day 2 of each Arm

Secondary outcomes (3)

  1. Vaping Topography: Puff Number

    Vaping topography measures will be obtained from self-reported participant vaping log during the ad libitum sessions and measured as puffs per minute.

    Measured: Days 1-3 of each Arm

  2. Vaping Topography: Puff Duration

    Vaping topography measures will be obtained from self-reported participant vaping log during the ad libitum sessions and measured as seconds per puff.

    Measured: Days 1-3 of each Arm

  3. Vaping Topography: Inter-Puff Interval

    Vaping topography measures will be obtained from self-reported participant vaping log during the ad libitum sessions and measured as seconds/minutes between puffs.

    Measured: Days 1-3 of each Arm

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2019
  2. Study start1 Jun 2023 (estimated)
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Why it stopped: Please see NCT04053868 for the current version of this study

Resources

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
Model description
Crossover Assignment
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04047836
Sponsor's protocol ID
19-27571
Other IDs
5R01DA031193
Status last verified
Aug 2023
First submitted
5 Aug 2019
Last updated
22 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Low Nicotine E-Liquid and Medium or High Nicotine E-Liquid 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 11 inclusion and 41 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: withdrawn, as of the sponsor's last update on 22 Aug 2023. 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 was withdrawn before enrolling participants, so there are no results.

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?

Nicotine Exposure (time frame: Day 1 of each Arm). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04047836.

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 22 Aug 2023.

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