Vaping High vs. Low Nicotine E-Liquid
Primary Purpose
Cardiovascular Risk Factor, Nicotine Dependence
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Nicotine E-Liquid
Medium or High Nicotine E-Liquid
Sponsored by
About this trial
This is an interventional basic science trial for Cardiovascular Risk Factor focused on measuring E-Cigarettes, Vaping, E-Cig Mods, E-Liquid
Eligibility Criteria
Inclusion Criteria:
- 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
- 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
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 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)
Sites / Locations
- University of California, San Francisco
- Zuckerberg San Francisco General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Low Nicotine
Medium or High Nicotine
Arm Description
Using an electronic cigarette, the patient will participate in a standardized vaping session using 3 mg/ml nicotine e-liquid.
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.
Outcomes
Primary Outcome Measures
Nicotine Exposure
Plasma nicotine area under curve (AUC) (ng/ml*h)
Cardiovascular Effects: Heart Rate
Participant heart rate will be measured in beats per minute throughout the inpatient stay.
Cardiovascular Effects: Systolic Blood Pressure
Participant systolic blood pressure will be taken for 24 hours during ad-lib e-cigarette use.
Cardiovascular Effects: Diastolic Blood Pressure
Participant diastolic blood pressure will be taken for 24 hours during ad-lib e-cigarette use.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04047836
First Posted
August 5, 2019
Last Updated
August 17, 2023
Sponsor
University of California, San Francisco
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT04047836
Brief Title
Vaping High vs. Low Nicotine E-Liquid
Official Title
Vaping High vs. Low Nicotine E-Liquid
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Please see NCT04053868 for the current version of this study
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Risk Factor, Nicotine Dependence
Keywords
E-Cigarettes, Vaping, E-Cig Mods, E-Liquid
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Nicotine
Arm Type
Other
Arm Description
Using an electronic cigarette, the patient will participate in a standardized vaping session using 3 mg/ml nicotine e-liquid.
Arm Title
Medium or High Nicotine
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Low Nicotine E-Liquid
Intervention Description
Participants will vape e-liquid with nicotine concentration of 3 mg/ml.
Intervention Type
Other
Intervention Name(s)
Medium or High Nicotine E-Liquid
Intervention Description
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 Measure Information:
Title
Nicotine Exposure
Description
Plasma nicotine area under curve (AUC) (ng/ml*h)
Time Frame
Day 1 of each Arm
Title
Cardiovascular Effects: Heart Rate
Description
Participant heart rate will be measured in beats per minute throughout the inpatient stay.
Time Frame
Days 1-3 of each Arm
Title
Cardiovascular Effects: Systolic Blood Pressure
Description
Participant systolic blood pressure will be taken for 24 hours during ad-lib e-cigarette use.
Time Frame
Day 2 of each Arm
Title
Cardiovascular Effects: Diastolic Blood Pressure
Description
Participant diastolic blood pressure will be taken for 24 hours during ad-lib e-cigarette use.
Time Frame
Day 2 of each Arm
Secondary Outcome Measure Information:
Title
Vaping Topography: Puff Number
Description
Vaping topography measures will be obtained from self-reported participant vaping log during the ad libitum sessions and measured as puffs per minute.
Time Frame
Days 1-3 of each Arm
Title
Vaping Topography: Puff Duration
Description
Vaping topography measures will be obtained from self-reported participant vaping log during the ad libitum sessions and measured as seconds per puff.
Time Frame
Days 1-3 of each Arm
Title
Vaping Topography: Inter-Puff Interval
Description
Vaping topography measures will be obtained from self-reported participant vaping log during the ad libitum sessions and measured as seconds/minutes between puffs.
Time Frame
Days 1-3 of each Arm
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
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
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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal Benowitz, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Zuckerberg San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Vaping High vs. Low Nicotine E-Liquid
We'll reach out to this number within 24 hrs