Antioxidant Replacement Therapy in Patients With Alcohol Abuse

• Register: ClinicalTrials.gov
• Last refreshed on: 11 February 2013
• Main ID: NCT00936000
• Date of registration: 07/07/2009
• Primary sponsor: University of Colorado, Denver
• Public title: Antioxidant Replacement Therapy in Patients With Alcohol Abuse
• Scientific title: Double Blinded Placebo Controlled Trial of Protandim for Individuals With a History of Alcohol Abuse
• Date of first enrolment: June 2009
• Target sample size: 38
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00936000
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Countries of recruitment

United States

Contacts

• Name: Marc Moss, M.D.
• Affiliation: University of Colorado, Denver

Key inclusion & exclusion criteria

Inclusion Criteria:

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 Criteria:

- 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)



Age minimum: 21 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Alcohol Abuse

Intervention(s)

Dietary Supplement: Protandim

Primary Outcome(s)

Improvement in alveolar capillary barrier function [Time Frame: within 7 days]

Secondary Outcome(s)

Improvement in alveolar macrophage function [Time Frame: within 7 days]

Secondary ID(s)

08-0622

Source(s) of Monetary Support

Please refer to primary and secondary sponsors