Acetaminophen-induced Hepatotoxicity in Chronic Alcohol Abusers

Hepatotoxicity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00137059
• Other study ID #: PSI R02-52
• Status: Completed
• Phase: N/A
• Start date: November 2002
• Est. completion date: May 2005

Study information

• Verified date: April 2024
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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 the investigators' 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. The investigators believe that a-GST may detect a subclinical acetaminophen-induced liver injury that has previously gone unrecognized in the alcoholic population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Hepatotoxicity

Intervention

Drug:
• acetaminophen sustained-release

Locations

Country	Name	City	State
Canada	Queen's University	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Marco L.A. Sivilotti

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum a-GST relative to baseline
Secondary	conventional liver function tests (LFTs)