Hepatic Function in Alcoholics Following 5 Days of Acetaminophen Dosing - Full Text View

Hepatic Function in Alcoholics Following 5 Days of Acetaminophen Dosing

This study has been completed.

Sponsors and Collaborators:	Denver Health and Hospital Authority 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)	Phase IV

ChemIDplus related topics:

Acetaminophen Ethanol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study

Official Title:	Hepatic Function Following Five Days of Therapeutic Dosing of Acetaminophen in Alcoholics

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

Estimated Enrollment:	250
Study Start Date:	November 2004
Estimated Study Completion Date:	December 2005

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

Study ID Numbers:	COMIRB #04-0486
First Received:	January 24, 2007
Last Updated:	January 25, 2007
ClinicalTrials.gov Identifier:	NCT00427206
Health Authority:	Canada: Health Canada

Keywords provided by Denver Health and Hospital Authority:

acetaminophen

alcohol

liver injury

Study placed in the following topic categories:

Mental Disorders

Substance-Related Disorders

Disorders of Environmental Origin

Alcohol-Related Disorders

Acetaminophen

Ethanol

Additional relevant MeSH terms:

Sensory System Agents

Analgesics, Non-Narcotic

Therapeutic Uses

Physiological Effects of Drugs

Peripheral Nervous System Agents

Analgesics

Central Nervous System Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 23, 2008