Hepatic Function in Alcoholics Following 5 Days of Acetaminophen Dosing

Study Overview
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Brief Summary
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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.

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

Conditions
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Alcohol Related Disorders

Intervention / Treatment
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* Drug: acetaminophen (4g/day)
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>acetaminophen 4 g/day | Drug: acetaminophen (4g/day)<br> <br> |
| Placebo Comparator: 2<br>placebo undistinguishable from active drug | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| group mean aminotransferase measures |  |  | 
| mean change in aminotransferase measures between study groups |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of subjects that develop an aminotransferase level greater than the upper limit of reference range |  |  | 
| proportion of subjects that develop hepatotoxicity (ALT>1000 IU/L) |  |  | 
| proportion of subjects that develop drug induced liver injury |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acetaminophen, alcohol, liver injury