Hepatic Function in Alcoholics Following 5 Days of Acetaminophen Dosing

Alcohol Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00427206
• Other study ID #: COMIRB #04-0486
• Status: Completed
• Phase: Phase 4
• First received: January 24, 2007
• Last updated: February 6, 2009
• Start date: November 2004
• Est. completion date: December 2005

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Alcohol Related Disorders
• Alcohol-Related Disorders

Intervention

Drug:
• acetaminophen (4g/day)

• placebo

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario
United States	Denver CARES	Denver	Colorado

Sponsors (2)

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

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	group mean aminotransferase measures
Primary	mean change in aminotransferase measures between study groups
Secondary	proportion of subjects that develop an aminotransferase level greater than the upper limit of reference range
Secondary	proportion of subjects that develop hepatotoxicity (ALT>1000 IU/L)
Secondary	proportion of subjects that develop drug induced liver injury