Status:
COMPLETED
Antioxidant Replacement Therapy in Patients With Alcohol Abuse
Lead Sponsor:
University of Colorado, Denver
Conditions:
Alcohol Abuse
Eligibility:
All Genders
21-55 years
Phase:
PHASE2
Brief Summary
Alcohol is one of the most commonly abused drugs in the world. Up to 40% of medical and surgical patients have alcohol related problems, and alcohol use accounts for more than 10% of U.S. health care ...
Eligibility Criteria
Inclusion
- Subjects will be eligible to participate in the study if they meet all of the following criteria at study entry:
- Alcohol Use Disorders Identification Test (AUDIT) score of 8 or more,
- Alcohol use within the seven days prior to enrollment
- Age ≥ 21 and \< 55 years
Exclusion
- Prior medical history of liver disease (documented history of cirrhosis, total bilirubin ≥ 2.0 mg/dL, or albumin \< 3.0)
- Prior medical history of gastrointestinal bleeding (due to the concern of varices)
- Prior medical history of heart disease (documentation of ejection fraction \< 50%, myocardial infarction, or severe valvular dysfunction)
- Prior medical history of renal disease (end-stage renal disease requiring dialysis, or a serum creatinine ≥ 2 mg/dL)
- Prior medical history of lung disease defined as an abnormal chest radiograph or spirometry (FVC or FEV1\<80%)
- Concurrent illicit drug use defined as a positive toxicology screen
- Prior history of diabetes mellitus
- Prior history of HIV infection
- Failure of the patient to provide informed consent
- Refusal of the patient's attending physician to provide consent to participate
- Pregnancy
- No prior history of recent acetaminophen use due to the effects of this drug on hepatic glutathione concentrations (96)
- History of malnutrition as defined as a Nutritional Risk Index of less than 90. This index relies on the serum albumin concentration and the percentage of usual body weight in the following manner; NRI = 100x \[1.59 x albumin (g/l)\] + \[0.417 x (current weight/usual body weight in the past 6 months)\].
- Homeless population (who do not have transitional housing)
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00936000
Start Date
June 1 2009
End Date
September 1 2010
Last Update
February 7 2013
Active Locations (1)
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1
University of Colorado Denver
Aurora, Colorado, United States, 80045