Hepatic Function in Alcoholics Following 5 Days of Acetaminophen Dosing
Completed · Phase 4 · Has a placebo group
Conditions studied: Alcohol Related Disorders
In brief
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.
Key facts
- Study ID
- NCT00427206
- Run by
- Denver Health and Hospital Authority
- People needed
- 181
- Starts
- 2004-11-01
- Expected to finish
- 2005-12-01
- Last updated by the study team
- 2009-02-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 18 years and older
- admitted to participating detox facility with a positive BAL at the time of admittance
- signed a written informed consent
You may not qualify if…
- 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.
Where it is running
- Denver CARES — Denver, Colorado, United States
- Centre for Addiction and Mental Health — Toronto, Ontario, Canada
Full record on ClinicalTrials.gov
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