Hepatic Function in Alcoholics Following 5 Days of Acetaminophen Dosing

Phase 4

Completed

• Conditions: Alcohol Related Disorders
• Interventions: Drug: acetaminophen (4g/day); Drug: placebo

• Registration Number: NCT00427206
• Lead Sponsor: Denver Health and Hospital Authority

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Study First Submitted: 2007-01-24
• Study First Submitted QC: 2007-01-25
• Study First Posted: 2007-01-26
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-06
• Last Update Posted: 2009-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	acetaminophen (4g/day)	acetaminophen 4 g/day
2	placebo	placebo undistinguishable from active drug

Primary Outcome Measures

Name	Time	Method
mean change in aminotransferase measures between study groups
group mean aminotransferase measures

Secondary Outcome Measures

Name	Time	Method
proportion of subjects that develop hepatotoxicity (ALT>1000 IU/L)
proportion of subjects that develop drug induced liver injury
proportion of subjects that develop an aminotransferase level greater than the upper limit of reference range

Trial Locations

Locations (2)

Denver CARES; 🇺🇸 Denver, Colorado, United States

Centre for Addiction and Mental Health; 🇨🇦 Toronto, Ontario, Canada