Phase
Condition
Alcohol Dependence
Alcohol Use Disorder
Substance Abuse
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Primary Inclusion Criteria:
Current diagnosis of DSM-IV alcohol dependence and/or diagnosis of DSM-IV opiatedependence within 3 months prior to screening
18 years or older
Desire to seek treatment for alcohol and/or opiate abuse/dependence
Agree to use contraception for the study duration if of childbearing potential
Written informed consent and willingness to perform study procedures
Stable address and phone and at least 1 source of contact information (eg, familymember, significant other)
Exclusion
Primary Exclusion Criteria:
Presence of opiates in the urine (as determined by urine drug test) on Day 0 prior tonaltrexone treatment
Clinically significant medical/psychological condition or abnormality at screening (ie, physical examination, electrocardiogram [ECG], hematology or blood chemistryevaluation, or urinalysis findings)
Clinically significant active hepatitis or hepatic failure evidenced by 1 of thefollowing: aspartate transaminase (AST) or alanine transaminase (ALT) higher than 3times the upper limit of normal (3xULN), hyperbilirubinemia (bilirubin >10% aboveULN), creatine phosphokinase (CPK) higher than 10xULN, prolonged prothrombintime(international normalized ratio ≥1.7), ascites, or esophageal variceal disease
Manifestation of suicidal ideation, psychotic symptoms (including significant violentbehavior), or psychiatric disorders that would compromise ability to complete thestudy
Participation in a formal methadone program currently or within prior 3 years
More than 2 prior medically supervised detoxification treatments in prior 3 years
Pregnancy or lactation
Current prescribed opiate therapy, or receipt of opiates within 7 days prior to studydrug dosing, or ongoing medical condition likely to require prescribed opiate therapyduring study period
Failed naloxone challenge on Day 0 (the challenge could be repeated up to 2 times,with at least 24 hours between attempts)
Participation in a clinical trial within 30 days of screening
Previous enrollment in a VIVITROL clinical trial
Receipt of any drug product administered as a gluteal injection within 180 days priorto Day 0 or anticipated need for gluteal injections during study period
Intolerance and/or hypersensitivity to naltrexone, naloxone, orpolylactide-co-polymers such as polylactide-co-glycolide (PLG)