Status:
COMPLETED
Short-Term Cardiovascular Effects of E-Cigarettes: Influence of Device Power
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Food and Drug Administration (FDA)
Conditions:
Cardiovascular Risk Factor
Nicotine Dependence
Eligibility:
All Genders
21+ years
Phase:
NA
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 us...
Detailed Description
This is a single-site, randomized, crossover study of experienced adult e-cigarette users to assess nicotine exposure, toxicant exposure, and the short-term CV effects of e-cigarette power. Three powe...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
- Participants with current or past depression and/or anxiety disorders will be reviewed by the study physician and considered for inclusion
- Psychiatric hospitalizations are not exclusionary, but study participation will be determined as per study physician'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 at the screening visit (THC \& prescribed medications okay)
- Opioid replacement therapy
- Positive urine cannabis is not exclusionary but participant must report use of cannabis in any form on not more than 2 times per week to be eligible
- Psychiatric medications:
- Current regular use of any psychiatric medications with the exception of Selective Serotonin Reuptake Inhibitor (SSRI) and serotonin-norepinephrine reuptake Inhibitor (SNRIs) and current evaluation by the study physician 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, dexamethasone, phenobarbital, and other anticonvulsant drugs).
- Concurrent use of nicotine-containing medications
- Other/Misc. Chronic Health Conditions
- Oral thrush
- Fainting
- Untreated thyroid disease
- Other "life threatening illnesses" as per study physician's discretion
- Pregnancy
- Pregnancy (self-reported and urine pregnancy test)
- Breastfeeding (determined by self-report)
- Concurrent participation in another clinical trial
- Inability to communicate in English
- Planning to quit smoking or vaping within the next 60 days
Key Trial Info
Start Date :
March 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03839745
Start Date
March 26 2019
End Date
December 31 2021
Last Update
July 1 2024
Active Locations (2)
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1
Zuckerberg San Francisco General Hospital
San Francisco, California, United States, 94110
2
University of California, San Francisco
San Francisco, California, United States, 94143