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Acetaminophen-Induced Hepatotoxicity in Chronic Alcohol Abusers

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ClinicalTrials.gov Identifier: NCT00137059
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : December 13, 2005
Sponsor:
Information provided by:
Queen's University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatotoxicity Drug: acetaminophen sustained-release Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Study Start Date : November 2002
Study Completion Date : May 2005

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. serum a-GST relative to baseline

Secondary Outcome Measures :
  1. conventional liver function tests (LFTs)

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00137059


Locations
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Canada, Ontario
Queen's University
Kingston, Ontario, Canada, K7L 3N6
Sponsors and Collaborators
Queen's University
Investigators
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Principal Investigator: Marco LA Sivilotti, MD, MSc Queen's University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00137059    
Other Study ID Numbers: PSI R02-52
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: December 13, 2005
Last Verified: August 2005
Additional relevant MeSH terms:
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Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics