Hepatic Function in Alcoholics Following 5 Days of Acetaminophen Dosing

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00427206

Enrollment

181

Registered

2007-01-26

Start date

2004-11-30

Completion date

2005-12-31

Last updated

2009-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Related Disorders

Keywords

acetaminophen, alcohol, liver injury

Brief summary

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.

Interventions

DRUGacetaminophen (4g/day)

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
group mean aminotransferase measures	—
mean change in aminotransferase measures between study groups	—

Secondary

Measure	Time frame
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	—

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026