Status:
COMPLETED
A Novel Pharmacotherapy for Alcoholism and Alcohol Liver Disease
Lead Sponsor:
Brown University
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcoholism,
Alcoholic Liver Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
It is proposed to test metadoxine (MTDX) that it is hypothesized to be significantly beneficial for the treatment of alcoholism and ALD. Metadoxine is currently approved in Europe for acute and chroni...
Detailed Description
Treatments for ALD have limited success when drinking continues. Cessation of alcohol consumption or a significant reduction in alcohol intake improves histology and survival of patients with any stag...
Eligibility Criteria
Inclusion
- age ≥18;
- females must be post-menopausal for ≥1 year, surgically sterile, or practicing a birth control before entry and throughout the study; have a negative urine pregnancy test at screening and before randomization;
- current DSM-IV diagnosis of alcohol use disorder (or if relevant at study start-DSM-V) with current (i.e. past 90 days prior to screening) "at-risk" drinking defined as an average overall consumption of ≥28 drinks/week for men and ≥21 drinks/week for women;
- desire abstinence;
- evidence of alcoholic liver disease (ALD) based on a thorough history, physical examination, and laboratory tests (i.e. the De Ritis ratio of AST:ALT ratio \~2:1), which is characteristic of ALD.
Exclusion
- lifetime DSM diagnosis of schizophrenia, bipolar disorder, or other psychosis;
- in the investigators' opinion, risk of suicide (e.g. active plan, or recent attempt in last year);
- current DSM-IV diagnosis of dependence on any psychoactive substance other than alcohol and nicotine;
- repeated positive urine screen for any substance other than marijuana;
- history of hospitalization for alcohol intoxication delirium or alcohol withdrawal delirium;
- Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) score \>10, at any assessment;
- having received a psychological and/or pharmacological treatment for alcohol or having participated in a treatment research study within the past 90 days;
- having participated in any clinical trial with an investigational agent within the past 30 days;
- treatment with levodopa/carbidopa or reported diagnosis of Parkinson's disease;
- AST and/or ALT \>10 x upper normal limit; Child-Pugh-Turcotte (CPT) score stage C, model for end-stage liver disease (MELD) score \>21 (CPT and MELD scores are assessed by blood tests - e.g. bilirubin, albumin, INR, Cr - and medical history); and/or medical history positive for decompensated liver disease (ascites, encephalopathy, variceal bleeding or hepatorenal syndrome) and/or medical history positive for hepatocellular carcinoma; 11) history of allergy to MTDX or PCA and pyridoxol;
- other serious illnesses, e.g. kidney failure.
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01504295
Start Date
April 1 2012
End Date
February 1 2015
Last Update
July 22 2015
Active Locations (1)
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1
Brown University Center for Alcohol and Addiction Studies
Providence, Rhode Island, United States, 02912