search
Back to results

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Withdrawn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
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

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

21 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
August 5, 2019
Last Updated
August 17, 2023
Sponsor
University of California, San Francisco
Collaborators
National Institute on Drug Abuse (NIDA)
search

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