Hookah Smoking, Carbon Monoxide, and Coronary Endothelial Function (NCT03166787) | Clinical Trial Compass
TerminatedPhase 1
Hookah Smoking, Carbon Monoxide, and Coronary Endothelial Function
Stopped: Due to the Pandemic and the nature of this study we decided to terminate this study.
United States60 participantsStarted 2017-08-15
Plain-language 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.
Who can participate
Age range
21 Years – 49 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 21-25 y/o hookah smokers: smoked hookah \> 12 times in the last 12 months.
* 21-25 y/o cigarette smokers: smoked \>100 cigarettes and smoked in the last 30 days.
* 35-49 y/o hookah smokers: smoke hookah at least once per week for \> 20 years.
* 35-49 y/o cigarette smokers: have \> 20 pack-year cigarette smoking history.
* All subjects must have:
* no history of illicit drug use or marijuana.
* no evidence of cardiopulmonary disease by history or physical.
* no diabetes with fasting blood glucose \<100 mg/dl.
* BP\<140/90 mmHg.
* resting heart rate\<100 bpm.
* BMI\<30kg•m2.
* no prescription medication.
* normal EKG and echocardiogram.
Exclusion Criteria:
* suboptimal echocardiographic window.
* exhaled CO\>10 ppm (smoking non-abstinence).
* positive pregnancy test.
* psychiatric illness.
* other conditions deemed unsafe to participate.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.