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Completed

NCT Number: NCT00137059

Acetaminophen-induced Hepatotoxicity in Chronic Alcohol Abusers

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.

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Key information

Conditions

Hepatotoxicity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen's University

Kingston, Ontario, K7L 3N6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

acetaminophen sustained-release

Drug

Primary outcomes

  1. serum a-GST relative to baseline

Secondary outcomes

  1. conventional liver function tests (LFTs)

Sponsors and collaborators

Lead sponsor

Dr. Marco L.A. Sivilotti

Other

Registry information

Important dates

Study start
2002
Study completion
2005
First posted
Aug 29, 2005
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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