Hepatic Function in Alcoholics Following 5 Days of Acetaminophen Dosing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2005-12-31

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.

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Detailed Description

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Conditions

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Alcohol Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

acetaminophen 4 g/day

Group Type ACTIVE_COMPARATOR

acetaminophen (4g/day)

Intervention Type DRUG

2

placebo undistinguishable from active drug

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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acetaminophen (4g/day)

Intervention Type DRUG

placebo

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes