Nicotine-free Hookah SmokingPhase 1/2NCT02310373
Effects of Nicotine-Free Hookah Smoking on Blood Flow to the Heart, Muscle and Skin
A Phase 1/2 study testing Nicotine free hookah smoking in people with Nicotine-free Hookah Smoking, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
This is a pilot study on the acute effects of nicotine-free hookah (herbal/steam stones) smoking on the sympathetic neural control of the human cardiovascular system. Hookah smoking is known to transiently increase blood pressure and heart rate while decreasing heart rate variability suggesting - but not proving … Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine-free Hookah Smoking
- What is being tested?
- Nicotine free hookah smoking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Dec 2018
- Phase
- Phase 1/2
- 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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 39 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
- Exhaled carbon monoxide level greater than 10 ppm* as evidence of current or recent cigarette (excluded if smoked cigarette within 12 months) or Hookah smoking (excluded if smoked Hookah within past 72 hours)
- History of cardiopulmonary disease
- Use of any prescription medication with exception of oral contraceptive pills
- History of psychiatric illness
- History of neurologic disease
- BMI ≥ 35
Show all 11Show fewer
- Evidence of any of the above by physical examination, ECG or echocardiogram
- Smoked cigarette in the past 12 months
- History of illicit drug use
- Pregnant
- Any other condition(s) deemed by the physician investigators that put subjects at risk for participating in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
This is a pilot study on the acute effects of nicotine-free hookah (herbal/steam stones) smoking on the sympathetic neural control of the human cardiovascular system. Hookah smoking is known to transiently increase blood pressure and heart rate while decreasing heart rate variability suggesting - but not proving - sympathetic mediation. The contribution of nicotine to these effects is unknown. Here the investigators will directly measure the acute effects of nicotine-free Hookah smoking on sympathetic nerve activity with microneurography (intraneural microelectrodes) and quantify associated regional changes in vasomotor tone.
- Conditions
- Nicotine-free Hookah Smoking
- Being tested
- Nicotine free hookah smoking
- Keywords
- Nicotine-free hookah, Waterpipe, Smoking, Sympathetic
- Medical subject headings
- Water Pipe Smoking, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine free hookah smokingOther
Subjects will smoke waterpipe in a controlled research environment
| Study group | Role | What they receive |
|---|---|---|
| Nicotine free hookah (herbal/steam stones) smoking | Experimental | Healthy habitual Hookah smokers will undergo microneurography, myocardial contrast echocardiogram or venous occlusion plethysmography before and after nicotine free hookah smoking. Receives: Other: Nicotine free hookah smoking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sympathetic nerve activity
Multi-unit recordings of sympathetic nerve activity will be obtained with single-use sterile tungsten microelectrodes inserted selectively into muscle or skin nerve fascicles of the peritoneal nerve.
Measured: Change from baseline in sympathetic nerve activity at 1 hr
Secondary outcomes (1)
Change in regional myocardial perfusion
Myocardial contrast echocardiography will be used to measure regional myocardial perfusion (i.e. capillary blood volume) and coronary flow reserve.
Measured: Change from baseline in regional myocardial perfusion at 1 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2018
- Study completionDec 2018
Why it stopped: Responsible Party/PI passed away. All subjects enrolled completed study prior to termination.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine-free 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 1/2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald G Victor, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310373
- Sponsor's protocol ID
- Pro00037529
- Status last verified
- Jan 2020
- First submitted
- 25 Nov 2014
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nicotine-Free Hookah Smoking on Blood Flow to the Heart, Muscle and Skin
- ClinicalTrials.gov ID
- NCT02310373
- Acronym / sponsor ID
- Pro00037529
- Conditions
- Nicotine-free Hookah Smoking
- Keywords
- Nicotine-free hookah, Waterpipe, Smoking, Sympathetic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Responsible Party/PI passed away. All subjects enrolled completed study prior to termination.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 8 Dec 2014 (estimated)
- 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.
This is a pilot study on the acute effects of nicotine-free hookah (herbal/steam stones) smoking on the sympathetic neural control of the human cardiovascular system. Hookah smoking is known to transiently increase blood pressure and heart rate while decreasing heart rate variability suggesting - but not proving - sympathetic mediation. The contribution of nicotine to these effects is unknown. Here the investigators will directly measure the acute effects of nicotine-free Hookah smoking on sympathetic nerve activity with microneurography (intraneural microelectrodes) and quantify associated regional changes in vasomotor tone.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nicotine free hookah (herbal/steam stones) smoking | Experimental | Other: Nicotine free hookah smokingHealthy habitual Hookah smokers will undergo microneurography, myocardial contrast echocardiogram or venous occlusion plethysmography before and after nicotine free hookah smoking. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 to 39 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 (11 listed)
- Exhaled carbon monoxide level greater than 10 ppm* as evidence of current or recent cigarette (excluded if smoked cigarette within 12 months) or Hookah smoking (excluded if smoked Hookah within past 72 hours)
- History of cardiopulmonary disease
- Use of any prescription medication with exception of oral contraceptive pills
- History of psychiatric illness
- History of neurologic disease
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 |
|---|---|---|
| Nicotine free hookah smokingSubjects will smoke waterpipe in a controlled research environment | Other | Nicotine free hookah (herbal/steam stones) smoking |
Primary outcome
Change in sympathetic nerve activity
Time frame: Change from baseline in sympathetic nerve activity at 1 hr
Multi-unit recordings of sympathetic nerve activity will be obtained with single-use sterile tungsten microelectrodes inserted selectively into muscle or skin nerve fascicles of the peritoneal nerve.
1 secondary outcome
Change in regional myocardial perfusion
Time frame: Change from baseline in regional myocardial perfusion at 1 hr
Results and safety
The study was stopped early (reason given: Responsible Party/PI passed away. All subjects enrolled completed study prior to termination.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
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.
Ronald G Victor 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 Phase 1/2 study testing Nicotine free hookah smoking in people with Nicotine-free 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 11 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 13 Jan 2020. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Responsible Party/PI passed away. All subjects enrolled completed study prior to termination.). 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?
Change in sympathetic nerve activity (time frame: Change from baseline in sympathetic nerve activity at 1 hr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2020.