Hepatic Function in Alcoholics Following 5 Days of Acetaminophen Dosing

Hepatic Function Following Five Days of Therapeutic Dosing of Acetaminophen in Alcoholics

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.

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.