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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00402571

Enrollment

420

Registered

2006-11-22

Start date

2002-01-31

Completion date

2004-07-31

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 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.

Interventions

DRUGacetaminophen

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
mean change in serum aminotransferase levels between study groups	—

Secondary

Measure	Time frame
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	—

Countries

United States

Outcome results

None listed

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