Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2025-12-24 @ 2:07 PM
NCT ID:
NCT01504295
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01504295
Study Brief:
Protocol Section:
NCT01504295