Completed

NCT Number: NCT00400621

Effects of Therapeutic Doses of Acetaminophen in Moderate Drinkers

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.

Completed

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Key information

Conditions

Moderate Alcohol Consumption (1-3 Drinks Per Day)

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetaminophen

Drug

Primary outcomes

mean change in serum ALT between treatment groups

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Denver Health and Hospital Authority

Other

Collaborators

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

Registry information

Official study title

Assessment of Hepatic Injury in Subjects Who Consume Moderate Amounts of Alcohol While Being Administered Therapeutic Doses of Acetaminophen:

Important dates

Study start: 2003
Study completion: 2003
First posted: Nov 17, 2006
Registry last updated: Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.