Effects of Therapeutic Doses of Acetaminophen in Moderate Drinkers

This study has been completed.

First Received: November 16, 2006 No Changes Posted

Sponsors and Collaborators:	Denver Health and Hospital Authority McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Information provided by:	Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:	NCT00400621

Purpose

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.

Condition	Intervention	Phase
Moderate Alcohol Consumption (1-3 Drinks Per Day)	Drug: acetaminophen	Phase IV

Study Type:

Interventional

Study Design:

Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study

Official Title:

Assessment of Hepatic Injury in Subjects Who Consume Moderate Amounts of Alcohol While Being Administered

Therapeutic Doses of Acetaminophen:

Resource links provided by NLM:

Drug Information available for: Acetaminophen CT 2584

U.S. FDA Resources

Further study details as provided by Denver Health and Hospital Authority:

Primary Outcome Measures:

mean change in serum ALT between treatment groups

Secondary Outcome Measures:

proportion of patients that developed an abnormal ALT
proportion of patients that developed hepatoxicity (ALT>1000 IU>L)
proportion of patients that developed drug induced liver injury

Estimated Enrollment:	150
Study Start Date:	April 2003
Estimated Study Completion Date:	September 2003

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria Adult volunteers of age 21 years or older, regardless of ethnicity or gender, who provided written consent and met all three of the following criteria of a moderate alcohol consumer:

Average baseline ethanol consumption of at least one alcoholic beverage per day before enrollment for the past two months. The estimate of ethanol intake was based on the average intake over seven days. For example, a person who ingested no alcohol on Sunday, Monday, Tuesday or Wednesday, two drinks on Thursday and four drinks on Friday and Saturday would be calculated as 10 drinks/7days = 1.4 drinks/day. The average alcoholic beverage contains 15 grams of alcohol(9).
Average baseline ethanol consumption of no more than three alcoholic beverages (> 45 grams of alcohol) per day, calculated as a weekly average over the preceding two months.
At least one alcohol-containing drink within the last 48 hours

Exclusion Criteria

Subjects were excluded from the study at baseline if any of the following were evident at baseline:

Serum acetaminophen level greater than 20 mcg/ml
Serum AST or ALT levels greater than 50 IU/L
If female, positive for b-HCG
Clinically intoxicated, psychiatrically impaired or unable to give informed consent
Known hypersensitivity to acetaminophen
History of ingesting more than four grams of acetaminophen per day for any of the four days preceding study enrollment
Alcoholic patients as defined by those who consume on average more than three alcoholic beverages daily
Currently enrolled in another trial or had been enrolled in another trial in the preceding three months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400621

Sponsors and Collaborators

Denver Health and Hospital Authority

McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Investigators

Principal Investigator:

Kennon Heard, MD

Rocky Mountain Poison Center

More Information

No publications provided

Study ID Numbers:	COMIRB 02-999
Study First Received:	November 16, 2006
Last Updated:	November 16, 2006
ClinicalTrials.gov Identifier:	NCT00400621 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Denver Health and Hospital Authority:

acetaminophen
alcohol
liver injury

Study placed in the following topic categories:

Analgesics, Non-Narcotic
Drinking Behavior
Peripheral Nervous System Agents
Analgesics

Alcohol Drinking
Acetaminophen
Ethanol

Additional relevant MeSH terms:

Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Physiological Effects of Drugs
Drinking Behavior
Peripheral Nervous System Agents

Analgesics
Alcohol Drinking
Central Nervous System Agents
Pharmacologic Actions
Acetaminophen

ClinicalTrials.gov processed this record on September 03, 2009