Hepatic Function in Alcoholics Following 5 Days of Acetaminophen Dosing

Condition(s) targeted: Alcohol Related Disorders

Intervention: acetaminophen (4g/day) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Denver Health and Hospital Authority

Official(s) and/or principal investigator(s):
Richard C Dart, MD, PhD, Principal Investigator, Affiliation: Denver Health/Rocky Mountain Poison & Drug Center
Bruna Brands, PhD, Principal Investigator, Affiliation: Centre for Addiction and Mental Health

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.

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

Study design: Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study

Primary outcome:

group mean aminotransferase measures

mean change in aminotransferase measures between study groups

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Denver CARES, Denver, Colorado 80204, United States

Centre for Addiction and Mental Health, Toronto, Ontario M5S 2S1, Canada

Starting date: November 2004
Ending date: December 2005
Last updated: January 25, 2007