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Completed

NCT Number: NCT00402571

Hepatic Function During and Following Three Days of Acetaminophen Dosing in Alcoholics

The study objective was to determine whether liver injury develops in alcoholic patients who ingest therapeutic doses of APAP for three consecutive days. Volunteers were recruited from two community detoxification centers to take either acetaminophen (4 g/day) or placebo for 3 consecutive days and remain in the facility an additional 2 days for monitoring. The primary measures were aminotransferase measures taken at baseline and Days 2-5. We hypothesized that there would be no difference in aminotransferase measures between the acetaminophen and placebo study groups.

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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

Denver CARES, Denver, Colorado, United States

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Any patient, regardless of gender or ethnicity, who was:

  • 18 years or older
  • admitted to one of the two controlled access alcohol detoxification centers with a positive BAL at the time of admittance
  • signed a written informed consent form.

Patients were excluded from the study at baseline if any of the following were present:

  • 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
  • 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

Drug

Primary outcomes

  1. mean change in serum aminotransferase levels between study groups

Secondary outcomes

  1. proportion of subjects tht developed an abnormal aminotransferase level

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

  3. proportion of subjects that developed 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

Assessment of Hepatic Function in Alcoholic Patients Administered Therapeutic Dosing of Acetaminophen- a Multicenter Study

Important dates

Study start
2002
Study completion
2004
First posted
Nov 22, 2006
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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