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

Condition(s) targeted: Alcohol Related Disorders

Intervention: acetaminophen (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

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.

Official title: Assessment of Hepatic Function in Alcoholic Patients Administered Therapeutic Dosing of Acetaminophen- a Multicenter Study

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

Primary outcome: mean change in serum aminotransferase levels between study groups

Secondary outcome:

proportion of subjects tht developed an abnormal aminotransferase level

proportion of subjects that developed hepatotoxicity (ALT>1000 IU/L)

proportion of subjects that developed drug induced liver injury

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

Criteria:

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.

Denver CARES, Denver, Colorado 80204, United States

Recovery Centers of King County, Seattle, Washington 98122, United States

Starting date: January 2002
Ending date: July 2004
Last updated: November 21, 2006