Hepatic Function in Alcoholics Following 5 Days of Acetaminophen Dosing

Denver Health and Hospital Authority

Status and phase

Completed

Phase 4

Conditions

Alcohol Related Disorders

Treatments

Drug: acetaminophen (4g/day)

Drug: placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00427206

COMIRB #04-0486

Details and patient eligibility

About

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.

Enrollment

181 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.