Status:
COMPLETED
Examination of Zinc, S-adenosylmethionine, and Combination Therapy Versus Placebo in Alcoholics
Lead Sponsor:
VA Office of Research and Development
Conditions:
Alcoholism
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
This is a randomized, placebo controlled trial of dietary zinc and S-adenosylmethionine (SAMe) in otherwise healthy alcoholic US Veterans. The primary goal is to determine if either dietary zinc or S-...
Detailed Description
Alcohol abuse is a major burden on society and even more of a problem in the Veteran population. Chronic alcohol ingestion can have serious health consequences including pneumonia and acute lung injur...
Eligibility Criteria
Inclusion
- Age 18-60 years
- Active alcohol use disorder
Exclusion
- Any active and uncontrolled medical problem(s)
- Known zinc deficiency
- Primary substance of abuse something other than alcohol
- Current abnormal chest x-ray
- HIV-positive
- Any disorder of blood coagulation
- Currently on medical treatment with anti-coagulants, including:
- warfarin
- heparin
- direct thrombin inhibitors
- anti-platelet agents (other than Aspirin)
- Daily use of vitamins or other nutritional supplements (unless taking as treatment for alcohol use disorder)
- Renal impairment (GFR \< 60)
- Active bipolar disorder
- Active Parkinson's disease
- Current pregnancy
- Contraindication to treatment with zinc or S-adenosylmethionine
- Inability to give informed consent (i.e., limited cognitive capacity)
- Non-English speaking
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2017
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT01899521
Start Date
May 1 2013
End Date
July 31 2017
Last Update
September 19 2024
Active Locations (1)
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1
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033