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

Alcohol Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00402571
• Other study ID #: COMIRB #00-715
• Status: Completed
• Phase: Phase 4
• First received: November 20, 2006
• Last updated: February 6, 2009
• Start date: January 2002
• Est. completion date: July 2004

Study information

• Verified date: February 2009
• Source: Denver Health and Hospital Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: July 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Alcohol Related Disorders
• Alcohol-Related Disorders

Intervention

Drug:
• acetaminophen

Locations

Country	Name	City	State
United States	Denver CARES	Denver	Colorado
United States	Recovery Centers of King County	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Denver Health and Hospital Authority	McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean change in serum aminotransferase levels between study groups
Secondary	proportion of subjects tht developed an abnormal aminotransferase level
Secondary	proportion of subjects that developed hepatotoxicity (ALT>1000 IU/L)
Secondary	proportion of subjects that developed drug induced liver injury