Hookah SmokingNCT03616002
Effects of Hookah (Waterpipe) Smoking on Blood Vessel Function
A study testing Hookah smoking in people with Hookah Smoking, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to assess the acute effects of Hookah (waterpipe) smoking on blood vessel function. Hookah smoking has been shown to immediately increase blood pressure and heart rate which could result in damage in the inner lining of the body's blood vessels. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Hookah Smoking
- What is being tested?
- Hookah smoking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2015to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 29 years of age
- Habitual Hookah smoker defined as having smoked Hookah >=12 times in the past 12 months
- Have not smoked cigarettes within the past 12 months
Who cannot join
- History of cardiopulmonary, diabetes, dyslipidemia or psychiatric disease
- Exhaled carbon monoxide level >10 ppm
- BP < 140/90 mmHg
- BMI <18.5 or > 30 kg•m2
- Resting heart rate > 100 beats/min
- Taking prescription medication
- History of illicit drug use
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Effects of Hookah Smoking on Vascular Regulation: Novel Insight Into Endothelial Function
The purpose of this study is to assess the acute effects of Hookah (waterpipe) smoking on blood vessel function. Hookah smoking has been shown to immediately increase blood pressure and heart rate which could result in damage in the inner lining of the body's blood vessels.
Read the detailed description
The investigators will measure acute endothelial and vascular changes before and after a 30-minute Hookah smoking session in a controlled laboratory environment to: (1) Determine the acute effects of Hookah smoking on large-vessel endothelial vasodilator function measured by brachial artery flow mediated dilation; (2) Determine the acute effects of Hookah smoking on micro-vessel endothelial function as measured by reactive hyperemia peripheral arterial tonometry; (3) Determine the acute effects of Hookah smoking on pulse wave velocity and aortic pressure waveform measured by pulse tonometry.
- Conditions
- Hookah Smoking
- Being tested
- Hookah smoking
- Medical subject headings
- Water Pipe Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hookah smokingOther
ad lib hookah smoking for 30 minutes in a controlled laboratory environment.
| Study group | Role | What they receive |
|---|---|---|
| Hookah smoking | Experimental | Healthy habitual Hookah smokers will undergo brachial artery flow mediated dilation, reactive hyperemia peripheral arterial tonometry or pulse tonometry before and after Hookah smoking. Receives: Other: Hookah smoking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial artery flow-mediated dilation
Measured: change from baseline to immediately after smoking
Secondary outcomes (1)
Reactive hyperemia peripheral arterial tonometry
Measured: change from baseline to immediately after smoking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start1 Jan 2015
- Primary completionMar 2020
- Study completionMar 2020
Why it stopped: Due tot he Pandemic we decided to terminate this project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hookah SmokingStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Florian Rader, Cedars-Sinai Medical Center
- Investigators
- Florian Rader, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616002
- Sponsor's protocol ID
- Pro00036547
- Status last verified
- Feb 2021
- First submitted
- 13 Jan 2015
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Rezk-Hanna M, Mosenifar Z, Benowitz NL, Rader F, Rashid M, Davoren K, Moy NB, Doering L, Robbins W, Sarna L, Li N, Chang LC, Elashoff RM, Victor RG. High Carbon Monoxide Levels from Charcoal Combustion Mask Acute Endothelial Dysfunction Induced by Hookah (Waterpipe) Smoking in Young Adults. Circulation. 2019 May 7;139(19):2215-2224. doi: 10.1161/CIRCULATIONAHA.118.037375.
PubMed 30764644
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hookah Smoking on Vascular Regulation: Novel Insight Into Endothelial Function
- ClinicalTrials.gov ID
- NCT03616002
- Acronym / sponsor ID
- Pro00036547
- Conditions
- Hookah Smoking
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due tot he Pandemic we decided to terminate this project.
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, University of California, San Francisco
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 6 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the acute effects of Hookah (waterpipe) smoking on blood vessel function. Hookah smoking has been shown to immediately increase blood pressure and heart rate which could result in damage in the inner lining of the body's blood vessels.
Detailed description
The investigators will measure acute endothelial and vascular changes before and after a 30-minute Hookah smoking session in a controlled laboratory environment to: (1) Determine the acute effects of Hookah smoking on large-vessel endothelial vasodilator function measured by brachial artery flow mediated dilation; (2) Determine the acute effects of Hookah smoking on micro-vessel endothelial function as measured by reactive hyperemia peripheral arterial tonometry; (3) Determine the acute effects of Hookah smoking on pulse wave velocity and aortic pressure waveform measured by pulse tonometry.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hookah smoking | Experimental | Other: Hookah smokingHealthy habitual Hookah smokers will undergo brachial artery flow mediated dilation, reactive hyperemia peripheral arterial tonometry or pulse tonometry before and after Hookah smoking. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 to 29 years of age
- Habitual Hookah smoker defined as having smoked Hookah >=12 times in the past 12 months
- Have not smoked cigarettes within the past 12 months
Key exclusion criteria (8 listed)
- History of cardiopulmonary, diabetes, dyslipidemia or psychiatric disease
- Exhaled carbon monoxide level >10 ppm
- BP < 140/90 mmHg
- BMI <18.5 or > 30 kg•m2
- Resting heart rate > 100 beats/min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hookah smokingad lib hookah smoking for 30 minutes in a controlled laboratory environment. | Other | Hookah smoking |
Primary outcome
Brachial artery flow-mediated dilation
Time frame: change from baseline to immediately after smoking
1 secondary outcome
Reactive hyperemia peripheral arterial tonometry
Time frame: change from baseline to immediately after smoking
Results and safety
The study was stopped early (reason given: Due tot he Pandemic we decided to terminate this project.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Derived from this study: PubMed 30764644Rezk-Hanna M, Mosenifar Z, Benowitz NL, Rader F, Rashid M, Davoren K, Moy NB, Doering L, Robbins W, Sarna L, Li N, Chang LC, Elashoff RM, Victor RG. High Carbon Monoxide Levels from Charcoal Combustion Mask Acute Endothelial Dysfunction Induced by Hookah (Waterpipe) Smoking in Young Adults. Circulation. 2019 May 7;139(19):2215-2224. doi: 10.1161/CIRCULATIONAHA.118.037375.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florian Rader, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hookah smoking in people with Hookah Smoking, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due tot he Pandemic we decided to terminate this project.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brachial artery flow-mediated dilation (time frame: change from baseline to immediately after smoking). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03616002, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.