Acetaminophen-Induced Hepatotoxicity in Chronic Alcohol Abusers - Full Text View

Sponsor:	Queen's University
Information provided by:	Queen's University
ClinicalTrials.gov Identifier:	NCT00137059

Purpose

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.

Condition	Intervention
Hepatotoxicity	Drug: acetaminophen sustained-release

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment

Resource links provided by NLM:

Drug Information available for: Acetaminophen CT 2584

U.S. FDA Resources

Further study details as provided by Queen's University:

Primary Outcome Measures:

serum a-GST relative to baseline

Secondary Outcome Measures:

conventional liver function tests (LFTs)

Estimated Enrollment:	40
Study Start Date:	November 2002
Estimated Study Completion Date:	May 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137059

Locations

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

Sponsors and Collaborators

Queen's University

Investigators

Principal Investigator:

Marco LA Sivilotti, MD, MSc

Queen's University

More Information

No publications provided by Queen's University

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	PSI R02-52
Study First Received:	August 26, 2005
Last Updated:	December 12, 2005
ClinicalTrials.gov Identifier:	NCT00137059 History of Changes
Health Authority:	Canada: Health Canada

Additional relevant MeSH terms:

Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Physiological Effects of Drugs
Peripheral Nervous System Agents

Analgesics
Central Nervous System Agents
Pharmacologic Actions
Acetaminophen

ClinicalTrials.gov processed this record on February 08, 2010