Comparison of Hookah and Cigarette Smoking

NCT00992550 | Completed Phase 1

• 1 other identifier: 10-05144
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Smoking

Keywords

hookah; cigarette; smoking

Outcome Measures

Primary Outcomes (1)

• smoke toxin excretion

  10 days

Secondary Outcomes (1)

• nicotine intake

  10 days

Study Arms (2)

Hookah visit, then cigarette visit

EXPERIMENTAL

4-day inpatient stays for profile of biomarker excretion

Drug: Cigarette; Drug: Hookah

Cigarette visit, then Hookah visit

EXPERIMENTAL

4-day inpatient stay for profile of biomarker excretion

Drug: Cigarette; Drug: Hookah

Interventions

Cigarette DRUG

Also known as: Participant will smoke their usual brand of cigarette

Cigarette visit, then Hookah visit; Hookah visit, then cigarette visit

Hookah DRUG

Also known as: participant will smoke hookah

Cigarette visit, then Hookah visit; Hookah visit, then cigarette visit

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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
• Oral thrush,
• Glaucoma,
• Thyroid disease,
• Urinary retention,
• Ulcer in past year,

Sponsors & Collaborators

• University of California, San Francisco: lead
• Tobacco Related Disease Research Program: collaborator

Study Sites (1)

San Francisco General Hospital-CTSI CRC

San Francisco, California, 94131, United States

Location

MeSH Terms

Conditions

Smoking; Water Pipe Smoking

Interventions

Tobacco Products; Smoking Water Pipes

Condition Hierarchy (Ancestors)

Behavior; Pipe Smoking

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture; Smoking Pipes

Study Officials

• Neal L Benowitz, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2009
• First Posted: October 9, 2009
• Study Start: October 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2011
• Last Updated: May 24, 2013

Record last verified: 2013-05

Locations

US (1)