Effects of Therapeutic Doses of Acetaminophen in Moderate Drinkers

This study has been completed.
Sponsor:
Collaborator:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Information provided by:
Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:
NCT00400621
First received: November 16, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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:


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:

  1. 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).
  2. 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.
  3. 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:

  1. Serum acetaminophen level greater than 20 mcg/ml
  2. Serum AST or ALT levels greater than 50 IU/L
  3. If female, positive for b-HCG
  4. Clinically intoxicated, psychiatrically impaired or unable to give informed consent
  5. Known hypersensitivity to acetaminophen
  6. History of ingesting more than four grams of acetaminophen per day for any of the four days preceding study enrollment
  7. Alcoholic patients as defined by those who consume on average more than three alcoholic beverages daily
  8. 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

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

Keywords provided by Denver Health and Hospital Authority:
acetaminophen
alcohol
liver injury

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Acetaminophen
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014