NCT00400621

Effects of Therapeutic Doses of Acetaminophen in Moderate Drinkers

Assessment of Hepatic Injury in Subjects Who Consume Moderate Amounts of Alcohol While Being Administered Therapeutic Doses of Acetaminophen:

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (planned)
• Sponsor: Denver Health and Hospital Authority · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

The study objective was to evaluate the safety of ten consecutive days of therapeutic acetaminophen dosing in moderate alcohol consumers. The main outcome was liver injury (measured by an increase in mean serum ALT or AST levels). Patients were randomly assigned to 10 days of acetaminophen or placebo. Blood tests were measured at baseline, day 4 and day 11 to look for injury. We hypothesized that there would be no difference in liver enzymes between the two groups.

Conditions

• Moderate Alcohol Consumption (1-3 Drinks Per Day)

Interventions

Type	Name	Description
DRUG	acetaminophen

Timeline

• Start date: 2003-04-01
• Completion: 2003-09-01
• First posted: 2006-11-17
• Last updated: 2024-07-08