COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

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: NCT00402571
Recruitment Status : Completed
First Posted : November 22, 2006
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 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.

Condition or disease Intervention/treatment Phase
Alcohol Related Disorders Drug: acetaminophen Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Official Title: Assessment of Hepatic Function in Alcoholic Patients Administered Therapeutic Dosing of Acetaminophen- a Multicenter Study
Study Start Date : January 2002
Study Completion Date : July 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. mean change in serum aminotransferase levels between study groups

Secondary Outcome Measures :
  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

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.

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

Inclusion Criteria

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

  1. 18 years or older
  2. admitted to one of the two controlled access alcohol detoxification centers with a positive BAL at the time of admittance
  3. signed a written informed consent form.

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

  1. serum acetaminophen level greater than 20 mcg/ml
  2. serum AST or ALT levels greater than 200 IU/L
  3. INR greater than 1.5
  4. if female, positive for beta-subunit of chorionic gonadotropin
  5. clinically intoxicated, psychiatrically impaired or unable to give informed consent
  6. known hypersensitivity to acetaminophen
  7. history of ingesting more than four grams of APAP per day for any of the four days preceding study enrollment
  8. 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): NCT00402571

Layout table for location information
United States, Colorado
Denver CARES
Denver, Colorado, United States, 80204
United States, Washington
Recovery Centers of King County
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Denver Health and Hospital Authority
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Layout table for investigator information
Principal Investigator: Richard C Dart, MD, PhD Denver Health/Rocky Mountain Poison & Drug Center
Layout table for additonal information Identifier: NCT00402571    
Other Study ID Numbers: COMIRB #00-715
First Posted: November 22, 2006    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:
Layout table for MeSH terms
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