SmokingPhase 16114NCT00992550
Comparison of Hookah and Cigarette Smoking
A Phase 1 study testing Cigarette and Hookah in people with Smoking, run by University of California, San Francisco at 1 site in United States.
Trial summary
The aim of this study is to compare exposure to tobacco smoke toxins in individuals who smoke both cigarettes and Hookah pipes. Sixteen subjects will be hospitalized on the research ward for two visits of 4 days each. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Cigarette and Hookah
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Mar 2011
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18 - 65 years
- Gender: Equal #s male \& female
- Ethnic/Racial Group: Any
- Smoking Status: Smokers of approximately 3 - 10 cigarettes per day; cotinine level of >20 ng/ml.
Who cannot join
- Medical: Exclude most any chronic illness requiring regular medication.
- Cardiac: History of angina or other serious heart disease; ECG abnormalities on screening.
- Hypertension: screening visit BP of 150/95 or more after 5 min rest
- Respiratory: Asthma - okay if in remission, otherwise exclude.
- Systemic: "Morbidly Obese" Exclude if BMI > 35
- Diabetes: By history
Show all 23Show fewer
- Chronic Active Hepatitis: By history; elevated liver function tests (LFTs)
- Cancers: By history
- Pregnancy/breastfeeding: By history; positive pregnancy test
- Other tobacco users (pipe, cigar, chewing tobacco, snuff users
- The following list of health conditions are routinely asked at Phone Screening and thus are exclusions "by history":
- Oral thrush,
- Glaucoma,
- Thyroid disease,
- Urinary retention,
- Ulcer in past year,
- Other "life threatening" illness,
- "Bad veins"; discomfort with blood draws,
- History of persistent fainting,
- Psychiatric (Any history of schizophrenia, major depression, or psychiatric hospitalization),
- Also any condition for which medications are being taken on a regular basis.
- Medications/Supplements: General Exclusion = "any regular oral and/or prescription drug use" with the exception of oral contraceptives and Thyroid (Synthroid)
- Drug/alcohol use: General "no abuse by history", no regular recreational drug use, any intravenous drug abuse (IVDA), recent hx of Tx program No smoking of marijuana or herbal products for one month prior to screening and no smoking of marijuana or herbal products between screening and final study day.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco General Hospital-CTSI CRC
San Francisco, California, 94131
About this study
The aim of this study is to compare exposure to tobacco smoke toxins in individuals who smoke both cigarettes and Hookah pipes. Sixteen subjects will be hospitalized on the research ward for two visits of 4 days each. At one visit they will smoke their usual cigarettes in approximately normal frequency, and at the other visit they will smoke Hookah at least twice per day. The order of the visits will be randomized. On the fourth day of each visit (when nicotine, carbon monoxide (CO), and some carcinogen levels will be in a steady state condition), circadian blood and urine and expired air samples will be collected.
Read the detailed description
Water pipes have been used to smoke various substances for at least four centuries, particularly in certain Asian countries, the Middle East, and Northern Africa. It is estimated that about 100 million people worldwide smoke tobacco in water pipes, which are also known as hookahs (Indian subcontinent and Africa), shisha, borry, goza (Egypt, Saudi Arabia), narghile, argilhe (Jordan, Lebanon, Syria, and Israel), shui yan dai (China), or hubble-bubble.
Water pipes consist of a head (to hold tobacco) which is connected to a body, which in turn is connected to a bowl containing water. A tobacco preparation is placed in the head, and burning charcoal is placed on top of the tobacco, often separated by perforated aluminum foil. The smoker inhales through the mouthpiece, which draws air over the burning charcoal and through the tobacco, creating an aerosol consisting of volatilized and pyrolized tobacco components. The smoke passes through the water in the bowl, cooling the smoke, before being carried through the hose to the smoker.
Hookah tobacco is different from ordinary tobacco in that it is a moist paste-like preparation made from about 30% crude, cut tobacco that is fermented with honey, molasses, and pulp of different fruits to add flavor. Consequently, differences in composition of the products smoked and different temperatures involved in the smoking process result in substantial difference in the composition of hookah smoke compared to cigarette smoke. Hookah smoke is produced at about 450° C compared to about 900° C for cigarettes. In addition, hookah smoke contains charcoal combustion products, which includes substantial amounts of carbon monoxide (3).
In one study, Shihadeh and Saleh found that hookah tobacco produced substantially more tar (100-fold), nicotine (4-fold), carbon monoxide (11-fold), and polycyclic aromatic hydrocarbons (PAHs, 2 to 5-fold) than did comparable amounts of cigarette tobacco. Shafagoj et al compared expired CO and plasma nicotine in cigarette and hookah smokers, and found that the hookah smokers had about 2-fold higher carbon monoxide levels and about 3-fold higher nicotine levels than cigarette smokers. The high delivery of nicotine is unexpected in light of its high water solubility.
Recently, smoking tobacco in water pipes has gained popularity in the US, particularly in areas with sizable Arab-American populations, and also among young non-Arab-Americanpeople, with a number of hookah bars being located near college campuses. A typical session at a hookah bar involves smoking for 45-60 minutes, often with a group of friends (1). In addition, hookahs, hookah tobacco, and accessories are advertised over the Internet. Most users of hookah tobacco believe that it is not addictive, and less harmful than cigarette smoking.
In light of published studies indicating high nicotine and carbon monoxide exposures in hookah smokers, the lack of data on exposure to other toxic substances, and global increases in the prevalence of hookah tobacco use, it is apparent that further research is needed. In the August, 2005 newsletter, Tobacco-Related Disease Research Program (TRDRP) invited research grant applications on all aspects of hookah smoke.
- Conditions
- Smoking
- Being tested
- Cigarette, Hookah
- Keywords
- hookah, cigarette, smoking
- Medical subject headings
- Smoking, Water Pipe Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CigaretteDrug
Also called Participant will smoke their usual brand of cigarette
HookahDrug
Also called participant will smoke hookah
| Study group | Role | What they receive |
|---|---|---|
| Hookah visit, then cigarette visit | Experimental | 4-day inpatient stays for profile of biomarker excretion Receives: Drug: Cigarette; Drug: Hookah |
| Cigarette visit, then Hookah visit | Experimental | 4-day inpatient stay for profile of biomarker excretion Receives: Drug: Cigarette; Drug: Hookah |
What is being measured
The primary outcome is the main question the study is designed to answer.
smoke toxin excretion
Measured: 10 days
Secondary outcomes (1)
nicotine intake
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Tobacco Related Disease Research Program
- Responsible party
- Sponsor
- Investigators
- Neal L Benowitz, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00992550
- Sponsor's protocol ID
- 10-05144
- Acronym
- 6114
- Status last verified
- May 2013
- First submitted
- 6 Oct 2009
- Last updated
- 24 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hookah and Cigarette Smoking
- ClinicalTrials.gov ID
- NCT00992550
- Acronym / sponsor ID
- 6114 / 10-05144
- Conditions
- Smoking
- Keywords
- hookah, cigarette, smoking
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Tobacco Related Disease Research Program
- Study start
- Oct 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 9 Oct 2009 (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.
The aim of this study is to compare exposure to tobacco smoke toxins in individuals who smoke both cigarettes and Hookah pipes. Sixteen subjects will be hospitalized on the research ward for two visits of 4 days each. At one visit they will smoke their usual cigarettes in approximately normal frequency, and at the other visit they will smoke Hookah at least twice per day. The order of the visits will be randomized. On the fourth day of each visit (when nicotine, carbon monoxide (CO), and some carcinogen levels will be in a steady state condition), circadian blood and urine and expired air samples will be collected.
Detailed description
Water pipes have been used to smoke various substances for at least four centuries, particularly in certain Asian countries, the Middle East, and Northern Africa. It is estimated that about 100 million people worldwide smoke tobacco in water pipes, which are also known as hookahs (Indian subcontinent and Africa), shisha, borry, goza (Egypt, Saudi Arabia), narghile, argilhe (Jordan, Lebanon, Syria, and Israel), shui yan dai (China), or hubble-bubble.
Water pipes consist of a head (to hold tobacco) which is connected to a body, which in turn is connected to a bowl containing water. A tobacco preparation is placed in the head, and burning charcoal is placed on top of the tobacco, often separated by perforated aluminum foil. The smoker inhales through the mouthpiece, which draws air over the burning charcoal and through the tobacco, creating an aerosol consisting of volatilized and pyrolized tobacco components. The smoke passes through the water in the bowl, cooling the smoke, before being carried through the hose to the smoker.
Hookah tobacco is different from ordinary tobacco in that it is a moist paste-like preparation made from about 30% crude, cut tobacco that is fermented with honey, molasses, and pulp of different fruits to add flavor. Consequently, differences in composition of the products smoked and different temperatures involved in the smoking process result in substantial difference in the composition of hookah smoke compared to cigarette smoke. Hookah smoke is produced at about 450° C compared to about 900° C for cigarettes. In addition, hookah smoke contains charcoal combustion products, which includes substantial amounts of carbon monoxide (3).
In one study, Shihadeh and Saleh found that hookah tobacco produced substantially more tar (100-fold), nicotine (4-fold), carbon monoxide (11-fold), and polycyclic aromatic hydrocarbons (PAHs, 2 to 5-fold) than did comparable amounts of cigarette tobacco. Shafagoj et al compared expired CO and plasma nicotine in cigarette and hookah smokers, and found that the hookah smokers had about 2-fold higher carbon monoxide levels and about 3-fold higher nicotine levels than cigarette smokers. The high delivery of nicotine is unexpected in light of its high water solubility.
Recently, smoking tobacco in water pipes has gained popularity in the US, particularly in areas with sizable Arab-American populations, and also among young non-Arab-Americanpeople, with a number of hookah bars being located near college campuses. A typical session at a hookah bar involves smoking for 45-60 minutes, often with a group of friends (1). In addition, hookahs, hookah tobacco, and accessories are advertised over the Internet. Most users of hookah tobacco believe that it is not addictive, and less harmful than cigarette smoking.
In light of published studies indicating high nicotine and carbon monoxide exposures in hookah smokers, the lack of data on exposure to other toxic substances, and global increases in the prevalence of hookah tobacco use, it is apparent that further research is needed. In the August, 2005 newsletter, Tobacco-Related Disease Research Program (TRDRP) invited research grant applications on all aspects of hookah smoke.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hookah visit, then cigarette visit | Experimental | Drug: Cigarette, Drug: Hookah4-day inpatient stays for profile of biomarker excretion |
| Cigarette visit, then Hookah visit | Experimental | Drug: Cigarette, Drug: Hookah4-day inpatient stay for profile of biomarker excretion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 18 - 65 years
- Gender: Equal #s male \& female
- Ethnic/Racial Group: Any
- Smoking Status: Smokers of approximately 3 - 10 cigarettes per day; cotinine level of >20 ng/ml.
Key exclusion criteria (23 listed)
- Medical: Exclude most any chronic illness requiring regular medication.
- Cardiac: History of angina or other serious heart disease; ECG abnormalities on screening.
- Hypertension: screening visit BP of 150/95 or more after 5 min rest
- Respiratory: Asthma - okay if in remission, otherwise exclude.
- Systemic: "Morbidly Obese" Exclude if BMI > 35
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 |
|---|---|---|
| CigaretteAlso: Participant will smoke their usual brand of cigarette | Drug | Cigarette visit, then Hookah visit, Hookah visit, then cigarette visit |
| HookahAlso: participant will smoke hookah | Drug | Cigarette visit, then Hookah visit, Hookah visit, then cigarette visit |
Primary outcome
smoke toxin excretion
Time frame: 10 days
1 secondary outcome
nicotine intake
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2013.
Related trials for Smoking
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
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.
Neal L Benowitz, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cigarette and Hookah in people with Smoking, run by University of California, San Francisco 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 4 inclusion and 23 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: finished, as of the sponsor's last update on 24 May 2013. 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 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
smoke toxin excretion (time frame: 10 days). 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 24 May 2013.