Hookah Smoking, Carbon Monoxide, and Coronary Endothelial Function
NCT03166787 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2021-04-09
Summary
Hookah (water pipe) smoking is a new global epidemic. The World Health Organization wants to prohibit all claims that hookah is less harmful than cigarettes and wants hookah products to bear the same warning labels as cigarettes. But there is little scientific evidence to substantiate this proposal. Cigarettes, cigars, medicinal nicotine, and e-cigarettes all acutely impair brachial artery endothelial function (flow-mediated dilation, FMD). Also, cigarettes cause both acute and chronic impairment in coronary endothelial function, but the comparative effects of hookah are unknown. Hookah tobacco is heated with burning charcoal. So, the smoke contains "tar" and nicotine plus charcoal combustion products. These include carbon monoxide (CO) and proatherogenic oxidants (especially carbon-rich nanoparticles) that the study team expected to impair endothelial function.
Conditions
- Smoking
- Endothelial Dysfunction
Interventions
- OTHER
-
Charcoal hookah
The Myocardial Blood Flow (MBF) will be measured at rest and during the last minute of a 3-minute bout of handgrip at 30% Maximal voluntary contraction. This sequence will be performed before and after 12 young hookah smokers are randomized to smoke the same popular Starbuzz tobacco product heated with either charcoal for 30 min each.
- OTHER
-
E-coal hookah
The Myocardial Blood Flow (MBF) will be measured at rest and during the last minute of a 3-minute bout of handgrip at 30% Maximal voluntary contraction. This sequence will be performed before and after 12 young hookah smokers are randomized to smoke the same popular Starbuzz tobacco product heated with electrically (Global First "e-coal," ) for 30 min each.
- OTHER
-
Cigarette
The Myocardial Blood Flow (MBF) will be measured at rest and during the last minute of a 3-minute bout of handgrip at 30% Maximal voluntary contraction. This sequence will be performed before and after 12 young cigarette smokers smoke 2 cigarettes down to the stub over 30 min (to simulate real-world use).
- DRUG
-
Carbon Monoxide inhalation
A subset (n=8) of the young hookah smokers will return on a later day and will be randomized to have coronary endothelial function assessed before and after inhaling 0.3 CO gas from a Douglas bag.
- OTHER
-
Room Air inhalation
A subset 8 of the young hookah smokers will return on a later day and will be randomized to have coronary endothelial function assessed before and after inhaling room air from a Douglas bag.
- DRUG
-
vitamin C
in a subset of 6 subjects the study team will repeat the Myocardial Contrast Echocardiography and speckle tracking studies after pretreatment with either i.v. vitamin C .
- DRUG
-
tadalafil
in a subset of 6 subjects the study team will repeat the Myocardial Contrast Echocardiography and speckle tracking studies after pretreatment with one dose of oral tadalafil.
Sponsors & Collaborators
-
National Institutes of Health (NIH)
collaborator NIH -
National Institute on Drug Abuse (NIDA)
collaborator NIH -
Cedars-Sinai Medical Center
lead OTHER
Principal Investigators
-
Ronald Victor, MD · Cedars-Sinai Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 49 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-08-15
- Primary Completion
- 2020-04-15
- Completion
- 2020-10-15
- FDA Drug
- Yes
Countries
- United States
Study Locations
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