Hepatic Function in Alcoholics Following 5 Days of Acetaminophen Dosing

This study has been completed.

First Received: January 24, 2007 Last Updated: February 6, 2009 History of Changes

Sponsor:	Denver Health and Hospital Authority
Collaborator:	McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Information provided by:	Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:	NCT00427206

Purpose

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	Intervention	Phase
Alcohol Related Disorders	Drug: acetaminophen (4g/day) Drug: placebo	Phase IV

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety Study
Official Title:	Hepatic Function Following Five Days of Therapeutic Dosing of Acetaminophen in Alcoholics

Resource links provided by NLM:

Drug Information available for: Acetaminophen CT 2584

U.S. FDA Resources

Further study details as provided by Denver Health and Hospital Authority:

Primary Outcome Measures:

group mean aminotransferase measures
mean change in aminotransferase measures between study groups

Secondary Outcome Measures:

proportion of subjects that develop an aminotransferase level greater than the upper limit of reference range
proportion of subjects that develop hepatotoxicity (ALT>1000 IU/L)
proportion of subjects that develop drug induced liver injury

Enrollment:	181
Study Start Date:	November 2004
Study Completion Date:	December 2005
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator acetaminophen 4 g/day	Drug: acetaminophen (4g/day)
2: Placebo Comparator placebo undistinguishable from active drug	Drug: placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00427206

Locations

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.

Investigators

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

More Information

No publications provided

Study ID Numbers:	COMIRB #04-0486
Study First Received:	January 24, 2007
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00427206 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Denver Health and Hospital Authority:

acetaminophen
alcohol
liver injury

Additional relevant MeSH terms:

Physiological Effects of Drugs
Disorders of Environmental Origin
Pharmacologic Actions
Mental Disorders
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses

Substance-Related Disorders
Alcohol-Related Disorders
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Acetaminophen

ClinicalTrials.gov processed this record on February 09, 2010