Hepatic Function in Alcoholics Following 5 Days of Acetaminophen Dosing

Sponsor

Denver Health and Hospital Authority (Other)

Overall Status

Completed

CT.gov ID

NCT00427206

Collaborator

McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. (Industry)

181

Enrollment

Locations

Arms

Duration (Months)

90.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Nov 1, 2004

Actual Primary Completion Date :

Dec 1, 2005

Actual Study Completion Date :

Dec 1, 2005

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: 1

acetaminophen 4 g/day

Drug: acetaminophen (4g/day)

Placebo Comparator: 2

placebo undistinguishable from active drug

Drug: placebo

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Denver CARES	Denver	Colorado	United States	80204
2	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