Acetaminophen-induced Hepatotoxicity in Chronic Alcohol Abusers

NCT00137059 | Completed

• 1 other identifier: PSI R02-52
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Hepatotoxicity

Outcome Measures

Primary Outcomes (1)

• serum a-GST relative to baseline

Secondary Outcomes (1)

• conventional liver function tests (LFTs)

Interventions

acetaminophen sustained-release DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Marco L.A. Sivilotti: lead

Study Sites (1)

Queen's University

Kingston, Ontario, K7L 3N6, Canada

Location

Related Publications (1)

• Bartels S, Sivilotti M, Crosby D, Richard J. Are recommended doses of acetaminophen hepatotoxic for recently abstinent alcoholics? A randomized trial. Clin Toxicol (Phila). 2008 Mar;46(3):243-9. doi: 10.1080/15563650701447020.

  PMID: 18344107 DERIVED

Study Officials

• Marco LA Sivilotti, MD, MSc

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Emergency Medicine, and of Biomedical & Molecular Science

Study Record Dates

• First Submitted: August 26, 2005
• First Posted: August 29, 2005
• Study Start: November 1, 2002
• Study Completion: May 1, 2005
• Last Updated: April 3, 2024

Record last verified: 2024-04

Locations

CA (1)