Comparison of Hookah and Cigarette Smoking (6114)

This study has been completed.
Sponsor:
Collaborator:
Tobacco Related Disease Research Program
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00992550
First received: October 6, 2009
Last updated: May 23, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Smoking
Drug: Cigarette
Drug: Hookah
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Comparison of Hookah and Cigarette Smoking

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • smoke toxin excretion [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • nicotine intake [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: October 2009
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hookah visit, then cigarette visit
4-day inpatient stays for profile of biomarker excretion
Drug: Cigarette
Other Name: Participant will smoke their usual brand of cigarette
Drug: Hookah
Other Name: participant will smoke hookah
Experimental: Cigarette visit, then Hookah visit
4-day inpatient stay for profile of biomarker excretion
Drug: Cigarette
Other Name: Participant will smoke their usual brand of cigarette
Drug: Hookah
Other Name: participant will smoke hookah

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00992550

Locations
United States, California
San Francisco General Hospital-CTSI CRC
San Francisco, California, United States, 94131
Sponsors and Collaborators
University of California, San Francisco
Tobacco Related Disease Research Program
Investigators
Principal Investigator: Neal L Benowitz, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00992550     History of Changes
Other Study ID Numbers: 10-05144
Study First Received: October 6, 2009
Last Updated: May 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
hookah
cigarette
smoking

ClinicalTrials.gov processed this record on October 23, 2014