It is widely believed that people who abuse alcohol can sustain liver injury after taking doses of acetaminophen just above the recommended maximum dose. This study is designed to look at the interaction between acetaminophen, liver injury and alcohol abuse. Subjects will undergo baseline tests to ensure that they do not have liver damage at the time of enrollment. Each subject will be randomly assigned to receive either a therapeutic dose of acetaminophen or a placebo three times a day for four days. Subjects will have blood work drawn on a daily basis to monitor the status of the liver. These tests will include conventional markers of liver injury in addition to a novel biomarker of liver function, a-GST. Previous work in our group has shown that a-GST is a more sensitive indicator of liver injury following acetaminophen overdose (Sivilotti 1999, Sivilotti 2002 x 2). However, it has never been used to study the alcoholic population. We believe that a-GST may detect subclinical acetaminophen-induced liver injury that has previously gone unrecognized in the alcoholic population.

Condition	Intervention
hepatotoxicity	Drug: acetaminophen sustained-release

Further Study Details: 

Primary Outcomes: serum a-GST relative to baseline
Secondary Outcomes: conventional LFTs
Expected Total Enrollment:  40

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

1. 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.
2. Last alcohol consumption occurring between 12 and 72 hours prior to screening for study.

Exclusion Criteria:

1. Individuals with a self-reported or previously documented history of hepatitis A, B, C or HIV.
2. Individuals who have ingested any acetaminophen regardless of dose in the previous 48 hours.
3. Individuals who have ingested > 4 gram of acetaminophen / day in any of the previous 7 days.
4. Individuals < 18 years of age.
5. Individuals with abnormal liver function at baseline (defined as AST or ALT > 120 IU/L, INR > 1.5, and "-GST > 7.5 7 :g/L).
6. Individuals who have an allergy or sensitivity to acetaminophen.

Canada, Ontario
      Queen''''s University, Kingston,  Ontario,  K7L 3N6,  Canada

Study chairs or principal investigators

Marco LA Sivilotti, MD, MSc,  Principal Investigator,  Queen''''s University   

Study ID Numbers:  PSI R02-52
Last Updated:  August 26, 2005
Record first received:  August 26, 2005
ClinicalTrials.gov Identifier:  NCT00137059
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-08-30