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Nicotine Administration & DosageNCT04053868

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

A study testing JUUL and Tobacco in people with Nicotine Administration & Dosage and E-cigarettes, run by University of California, San Francisco at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 70 yearsHealthy volunteers can take part
What is being tested?
JUUL and Tobacco
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
2 sitesUnited States
Study dates
9 Dec 2019to 31 Mar 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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)
  • - - 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
Show all 17Show fewer
  • 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)

Who cannot join

  • Medical
  • - Heart disease
  • - Seizures
  • - Cancer
  • - Thyroid disease (okay if controlled with medication)
  • - Diabetes
Show all 49Show 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 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

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

Other trials in United States

About this study

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.

Read the 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.

Being tested
JUUL, Tobacco
Medical subject headings
Vaping, Tobacco Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JUULOther

    Electronic Cigarette

  • TobaccoOther

    Tobacco Cigarette

Study groups in NCT04053868
Study groupRoleWhat they receive
Electronic CigaretteExperimentalThe participants will participate in a standardized vaping session using a JUUL E-cigarette device with a JUUL e-liquid pod.
Receives: Other: JUUL
Tobacco CigaretteExperimentalThe participants will participate in a standardized smoking session using commercial tobacco cigarettes.
Receives: Other: Tobacco

What is being measured

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

  1. Mean Nicotine Exposure

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

    Measured: Plasma collected at baseline (prior to any product use) and at 2, 5, 7, 10, 15, 30, 60, 90, and 118 minutes after end of standardized session.

Secondary outcomes (6)

  1. Overall Mean Heart Rate Over Time

    Participant heart rate will be measured in beats per minute (bpm) at baseline (before any use of products) and at 2, 5, 7, 10, 15, 30, 45, 60, 75, 90, 100,and 118 minutes after the standardized sessions of e-cigarette and tobacco cigarette use. The mean of each time point will be averaged over time.

    Measured: Up to 118 minutes after end of standardized session.

  2. Mean Systolic Blood Pressure Over Time

    Participant systolic blood pressure will be taken at Baseline (prior to use of any product) and at 5, 10, 15, 30, 45, 60, 75, 90, 100, and 118 minutes after the standardized sessions of e-cigarette and/or tobacco cigarette use on each arm. The mean of each time point will be averaged over time.

    Measured: Up to 118 minutes after end of standardized session.

  3. Mean Diastolic Blood Pressure Over Time

    Participant diastolic blood pressure will be taken at Baseline (prior to use of any product) and at 5, 10, 15, 30, 45, 60, 75, 90, 100, and 118 minutes after the standardized session during e-cigarette and/or tobacco cigarette use on each arm. The mean of each time point will be averaged over time.

    Measured: Up to 118 minutes after end of standardized session.

  4. Mean Questionnaire of Smoking Urges (QSU) and Modified for E-cigarettes (mQSU) Score Over Time

    The QSU (Questionnaire of Smoking Urges) is a self-report survey, modified to replace "cigarette" with "e-cigarette" and "smoking" with "vaping" for use during both the tobacco cigarette and the E-cigarette Arm. This instrument is composed of 10 items; 5 items measuring desire/intention to smoke/vape with smoking/vaping perceived as rewarding (Factor 1), and 5 items measuring anticipation of relief from negative affect with an urgent desire to smoke/vape (Factor 2). Scores for each factor (1 and 2) range from 5-35 with higher scores indicating more severe craving. The mean and standard deviation will be reported.

    Measured: Up to 118 minutes after end of standardized session

  5. Mean Minnesota Nicotine Withdrawal Scale (MNWS) Score Over Time

    The Minnesota Nicotine Withdrawal Scale is an 15-item self -report scale designed to measure the severity of craving and withdrawal symptoms experienced during smoking cessation. Each item is on a scale of 0 to 4 with 0=none to 4=Severe. The responses to each item are summed to produce a total withdrawal summary score with a possible range between 0 and 60, with higher scores indicating greater withdrawal symptom severity with greater scores indicating a higher level of severity in nicotine withdrawal symptoms overall. The mean and standard deviation will be reported.

    Measured: Up to 118 minutes after end of standardized session.

  6. Mean Cigarette Evaluation Scale (CES) and Modified for E-cigarettes (mCES) Score Over Time

    The CES is a self-report survey measuring smoking/vaping satisfaction, psychological reward, aversion, sensations, and craving reduction. This 12-item instrument has a total score range from 12 to 84, with higher scores indicating higher perception of the above factors. The mean and standard deviation will be reported.

    Measured: Up to 240 minutes after end of standardized session

Timeline

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

  1. First posted13 Aug 2019
  2. Study start9 Dec 2019
  3. Primary completion31 Mar 2022
  4. Study completion31 Mar 2022

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
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04053868
Sponsor's protocol ID
19-28309
Other IDs
2R01DA039264-04A1
Status last verified
Oct 2025
First submitted
9 Aug 2019
Last updated
16 Oct 2025
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 JUUL and Tobacco in people with Nicotine Administration & Dosage and E-cigarettes, 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 17 inclusion and 49 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 16 Oct 2025. 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?

Yes. Results are posted in the registry (first posted 15 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Exposure (time frame: Plasma collected at baseline (prior to any product use) and at 2, 5, 7, 10, 15, 30, 60, 90, and 118 minutes after end of standardized session.). 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 NCT04053868.

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 16 Oct 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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