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:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT01218958
Eligibility Criteria:
Primary Inclusion Criteria:
* Diagnosis of alcohol dependence based on Diagnostic and Statistical Manual of Mental Disorders, 4th Ed. (DSM-IV) criteria
* Male or non-pregnant, non-lactating female
* Able to provide TimeLine Follow-Back (TLFB) alcohol consumption information for 90-day period before detoxification and/or screening
* At least 2 episodes of heavy alcohol drinking per week during the 30 days before detoxification and/or screening
* Negative urine toxicological screen for opiates on day of randomization
* Noncustodial, stable residence and phone plus 1 contact with verifiable address and phone
Primary Exclusion Criteria:
* Evidence of hepatic failure including: ascites, prolonged prothrombin time (PT) (international normalized ratio \[INR\] ≥1.7), bilirubin \>10% above upper limit of normal (ULN) and/or esophageal variceal disease
* Active hepatitis and/or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) higher than 3xULN
* History of pancreatitis
* Major depression with suicidal ideation, psychosis, bipolar disorder, or psychiatric disorders that would compromise subject's ability to complete the study
* Current dependence (within past year) per DSM-IV criteria to benzodiazepines, opioids or cocaine
* Use of benzodiazepines and/or Ambien® (zolpidem tartrate) within 7 days prior to first dose of study medication
* Greater than 7 days inpatient treatment for substance use disorders within 30 days of randomization
* Use of any opioids and/or methadone within 14 days of screening, or likely requiring opioid therapy during study period
* Use of oral naltrexone or disulfiram within 14 days of screening
* Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or polylactide-co-glycolide (PLG)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01218958
Study Brief:
Protocol Section:
NCT01218958