Hepatic Function in Alcoholics Following 5 Days of Acetaminophen Dosing

Denver Health and Hospital Authority181 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

181

Conditions

Alcohol Related Disorders

Interventions

acetaminophen (4g/day)DRUG

placeboDRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Denver CARES

Denver, Colorado, United States

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

group mean aminotransferase measures

mean change in aminotransferase measures between study groups

Secondary Outcomes

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

Data from ClinicalTrials.gov

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