E Cigarette Use, HIV I Infection, Inflammation, Nicotine Use Disorder, Oxidative Stress, Qt Interval, Variation in, Smoking, Tobacco Smoking, Vaping
Conditions
Brief summary
Randomized controlled trial of acute use of electronic cigarette or tobacco cigarette on parameters of ventricular repolarization and inflammation/oxidative stress.
Detailed description
On separate days, participants will undergo 3 different exposures: an acute e-cigarette exposure, an acute tobacco cigarette exposure, and a sham (empty e-cigarette) control . Before and after the acute exposure, participants will have blood drawn for inflammation/oxidative stress markers and undergo a 5-minute ECG recording.
Interventions
OTHERTCIG
Use a TCIG
OTHERECIG
Use an ECIG
OTHERsham control
Use a sham control (empty ECIG)
Sponsors
Tobacco Related Disease Research Program
University of California, Los Angeles
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
single (outcomes assessor) code
Intervention model description
Crossover with 1 week washout
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Chronic (\> 1year) TCIG smoker HIV positive Stable ART Viral count non-detectable CD4 \>500
Exclusion criteria
Known major illness (heart disease, diabetes, lung or liver disease) Daily recreational drug use, including cannabis \>2 alcoholic drinks per day Obesity (\>30 kg/m2) Recent (\<3 months) infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tpe | Change in Tpe 5 minutes after cigarette use | interval indicative of ventricular repolarization measured on ECG |
| Tpe/QT | Change in Tpe/QT after cigarette use | interval indicative of ventricular repolarization measured on ECG |
| Tpe/QTc | Change in Tpe/QTc after cigarette use | interval indicative of ventricular repolarization measured on ECG |
| Total Cellular Reactive Oxygen Stress | within 4 hours of cigarette use | total cellular oxidative stress measured by flow cytometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QT | Change in QT after cigarette use | interval indicative of ventricular repolarization measured on ECG |
| QTc | Change in QTc after cigarette use | interval indicative of ventricular repolarization measured on ECG |
Countries
United States
Outcome results
None listed