Hepatic Function During and Following Three Days of Acetaminophen Dosing in Alcoholics
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Outcome Measures
Primary Outcome Measures
- mean change in serum aminotransferase levels between study groups []
Secondary Outcome Measures
- proportion of subjects tht developed an abnormal aminotransferase level []
- proportion of subjects that developed hepatotoxicity (ALT>1000 IU/L) []
- proportion of subjects that developed drug induced liver injury []
Eligibility Criteria
Criteria
Inclusion Criteria
Any patient, regardless of gender or ethnicity, who was:
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18 years or older
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admitted to one of the two controlled access alcohol detoxification centers with a positive BAL at the time of admittance
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signed a written informed consent form.
Patients were excluded from the study at baseline if any of the following were present:
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serum acetaminophen level greater than 20 mcg/ml
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serum AST or ALT levels greater than 200 IU/L
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INR greater than 1.5
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if female, positive for beta-subunit of chorionic gonadotropin
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clinically intoxicated, psychiatrically impaired or unable to give informed consent
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known hypersensitivity to acetaminophen
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history of ingesting more than four grams of APAP per day for any of the four days preceding study enrollment
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currently enrolled in another trial or had been enrolled in another trial in the preceding three months.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Denver CARES | Denver | Colorado | United States | 80204 |
| 2 | Recovery Centers of King County | Seattle | Washington | United States | 98122 |
Sponsors and Collaborators
- Denver Health and Hospital Authority
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Investigators
- Principal Investigator: Richard C Dart, MD, PhD, Denver Health/Rocky Mountain Poison & Drug Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- COMIRB #00-715