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Hepatic Function in Alcoholics Following 5 Days of Acetaminophen Dosing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00427206
Recruitment Status : Completed
First Posted : January 26, 2007
Last Update Posted : February 9, 2009
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Information provided by:
Denver Health and Hospital Authority

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alcohol Related Disorders Drug: acetaminophen (4g/day) Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Official Title: Hepatic Function Following Five Days of Therapeutic Dosing of Acetaminophen in Alcoholics
Study Start Date : November 2004
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
acetaminophen 4 g/day
Drug: acetaminophen (4g/day)
Placebo Comparator: 2
placebo undistinguishable from active drug
Drug: placebo

Primary Outcome Measures :
  1. group mean aminotransferase measures
  2. mean change in aminotransferase measures between study groups

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00427206

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United States, Colorado
Denver CARES
Denver, Colorado, United States, 80204
Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5S 2S1
Sponsors and Collaborators
Denver Health and Hospital Authority
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
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Principal Investigator: Richard C Dart, MD, PhD Denver Health/Rocky Mountain Poison & Drug Center
Principal Investigator: Bruna Brands, PhD Centre for Addiction and Mental Health

Layout table for additonal information Identifier: NCT00427206    
Other Study ID Numbers: COMIRB #04-0486
First Posted: January 26, 2007    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: February 2009
Keywords provided by Denver Health and Hospital Authority:
liver injury
Additional relevant MeSH terms:
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Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs