Comparison of Hookah and Cigarette Smoking

Completed · Phase 1

Conditions studied: Smoking

In brief

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.

Key facts

Study ID

NCT00992550

Run by

University of California, San Francisco

People needed

13

Starts

2009-10-01

Expected to finish

2011-03-01

Last updated by the study team

2013-05-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• San Francisco General Hospital-CTSI CRC — San Francisco, California, United States

Full record on ClinicalTrials.gov

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