NCT00427206

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2004

Shorter than P25 for phase_4

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 26, 2007

Completed
Last Updated

February 9, 2009

Status Verified

February 1, 2009

Enrollment Period

1.1 years

First QC Date

January 24, 2007

Last Update Submit

February 6, 2009

Conditions

Alcohol Related Disorders

Keywords

acetaminophenalcoholliver injury

Outcome Measures

Primary Outcomes (2)

  • group mean aminotransferase measures

  • mean change in aminotransferase measures between study groups

Secondary Outcomes (3)

  • 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

Study Arms (2)

1

ACTIVE COMPARATOR

acetaminophen 4 g/day

Drug: acetaminophen (4g/day)

2

PLACEBO COMPARATOR

placebo undistinguishable from active drug

Drug: placebo

Interventions

acetaminophen (4g/day)DRUG
1
placeboDRUG
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and older
  • admitted to participating detox facility with a positive BAL at the time of admittance
  • signed a written informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Denver CARES

Denver, Colorado, 80204, United States

Location

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

MeSH Terms

Conditions

Alcohol-Related Disorders

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Richard C Dart, MD, PhD

    Denver Health/Rocky Mountain Poison & Drug Center

    PRINCIPAL INVESTIGATOR

  • Bruna Brands, PhD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 24, 2007

First Posted

January 26, 2007

Study Start

November 1, 2004

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

February 9, 2009

Record last verified: 2009-02

Locations

US(1)CA(1)