Status:
COMPLETED
Acetaminophen-induced Hepatotoxicity in Chronic Alcohol Abusers
Lead Sponsor:
Dr. Marco L.A. Sivilotti
Conditions:
Hepatotoxicity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
It is widely believed that people who abuse alcohol can sustain a liver injury after taking doses of acetaminophen just above the recommended maximum dose. This study is designed to look at the intera...
Eligibility Criteria
Inclusion
- Individuals who self-report consuming at least 6 drinks per day, daily, for at least 6 weeks and who are currently enrolled at the Detoxification Center, Hotel Dieu Hospital.
- Last alcohol consumption occurring between 12 and 72 hours prior to screening for study.
Exclusion
- Individuals with a self-reported or previously documented history of hepatitis A, B, C or HIV.
- Individuals who have ingested any acetaminophen regardless of dose in the previous 48 hours.
- Individuals who have ingested \> 4 grams of acetaminophen/day in any of the previous 7 days.
- Individuals \< 18 years of age.
- Individuals with abnormal liver function at baseline (defined as AST or ALT \> 120 IU/L, International Normalized Ratio \[INR\] \> 1.5, and a-GST \> 7.5 7 :g/L).
- Individuals who have an allergy or sensitivity to acetaminophen.
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00137059
Start Date
November 1 2002
End Date
May 1 2005
Last Update
April 3 2024
Active Locations (1)
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1
Queen's University
Kingston, Ontario, Canada, K7L 3N6