Short-Term Cardiovascular Effects of E-Cigarettes: Influence of Device Power

NCT03839745 | Completed

• 3 other identifiers: 17239655U54HL147127NCI-2021-01564
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief 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). 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.

Conditions

Cardiovascular Risk Factor; Nicotine Dependence

Keywords

E-Cigarettes; Vaping; E-Cig Mods

Outcome Measures

Primary Outcomes (10)

• Mean nicotine levels

  Concentration of plasma nicotine (ng/ml) will be used to assess differences in nicotine exposure across the three power levels.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  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.

  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.

  Day 1-2 of each Arm

Secondary Outcomes (3)

• Mean puffs per minute

  Day 1 of each Arm

• Mean puff duration

  Day 1 of each Arm

• Mean inter-puff interval

  Day 1 of each Arm

Study Arms (3)

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

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

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

Other: Electronic Cigarette

Interventions

Electronic Cigarette OTHER

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.

1 of the other 2 remaining power levels; Power level 10, 15, or 20 watts; Remaining power level

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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)
• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Food and Drug Administration (FDA): collaborator

Study Sites (2)

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Vaping

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Smoking; Behavior

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Gideon St. Helen, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: February 15, 2019
• Study Start: March 26, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)