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Completed

NCT Number: NCT00427206

Hepatic Function in Alcoholics Following 5 Days of Acetaminophen Dosing

The study objective was to determine if liver injury develops in alcoholic patients during or following 5 days of therapeutic acetaminophen dosing. Volunteers were recruited from two community detoxification centers to take either acetaminophen (4g/day) or placebo for 5 consecutive days. All subjects were monitored an additional two days following the dosing period. The primary measures were aminotransferase measures taken at baseline and Days 2, 4, 6 and 7. We hypothesized that there would be no difference in aminotransferase means between the groups at any study period.

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Key information

Conditions

Alcohol Related Disorders Alcohol-Related Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre for Addiction and Mental Health, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18 years and older
  • admitted to participating detox facility with a positive BAL at the time of admittance
  • signed a written informed consent

Exclusion criteria

  • serum acetaminophen level greater than 20 mcg/ml
  • serum AST or ALT levels greater than 200 IU/L
  • INR greater than 1.5
  • if female, positive for beta-subunit of chorionic gonadotropin (beta-HCG)
  • clinically intoxicated, psychiatrically impaired or unable to give informed consent
  • known hypersensitivity to acetaminophen
  • history of ingesting more than four grams of APAP per day for any of the four days preceding study enrollment
  • currently enrolled in another trial or had been enrolled in another trial in the preceding three months.

Treatment and study plan

acetaminophen (4g/day)

Drug

Placebo

Drug

Primary outcomes

  1. group mean aminotransferase measures

  2. mean change in aminotransferase measures between study groups

Secondary outcomes

  1. proportion of subjects that develop an aminotransferase level greater than the upper limit of reference range

  2. proportion of subjects that develop hepatotoxicity (ALT>1000 IU/L)

  3. proportion of subjects that develop drug induced liver injury

Sponsors and collaborators

Lead sponsor

Denver Health and Hospital Authority

Other

Collaborators

  • McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Registry information

Official study title

Hepatic Function Following Five Days of Therapeutic Dosing of Acetaminophen in Alcoholics

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jan 26, 2007
Registry last updated
Feb 9, 2009

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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