Status:
COMPLETED
Comparison of Hookah and Cigarette Smoking
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Tobacco Related Disease Research Program
Conditions:
Smoking
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 visit...
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 millio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00992550
Start Date
October 1 2009
End Date
March 1 2011
Last Update
May 24 2013
Active Locations (1)
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1
San Francisco General Hospital-CTSI CRC
San Francisco, California, United States, 94131