Cotinine Metabolism in Infants and Children

Completed · Phase 1

Conditions studied: Secondhand Smoke Exposure

In brief

Levels of cotinine, a biomarker for nicotine, have been found to be higher in infants and small children than adults. This pharmacokinetic study is designed to determine whether children metabolize cotinine differently than adults. Seventy-two healthy children between the ages of 2 months and 6 years will come with their mothers to SFGH GCRC for one approximately 9 hour visit. After being examined by a pediatrician, the child will be administered one dose of cotinine at .05 mg/kg. Saliva and urine samples will be collected prior to dosing and throughout the day to characterize the metabolism and excretion of cotinine. The investigators have previously shown that a ratio of 3'-hydroxycotinine/cotinine (3HC/Cot) in saliva correlates closely to nicotine metabolism. Following these one day hospital visits, a research assistant will visit the participants in their homes to collect urine and saliva samples at 1,2,3,7, and 10 days after the initial dose.

Key facts

Study ID

NCT00994591

Run by

University of California, San Francisco

People needed

56

Starts

2007-01-01

Expected to finish

2011-06-01

Last updated by the study team

2013-05-24

Who can join

Age: 0 and older, up to 6. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Ages: 12 months, 13-24 months, and 25-83 months
• Caucasian (including Hispanic) and African American only
• Some exposure to secondhand smoke

You may not qualify if…

• Any medical problems
• Taking prescription medication (there are exceptions)

Where it is running

• University of California, San Francisco, SFGH, CTSI,CRC — San Francisco, California, United States

Full record on ClinicalTrials.gov

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