ALK21-006: Long-Term Study of Medisorb® Naltrexone (VIVITROL®)
Condition: Alcoholism
MeSH terms: Alcoholism
Intervention: Medisorb naltrexone 380 mg; Oral naltrexone 50 mg
Intervention description: Administered via intramuscular (IM) injection once every 4 weeks for up to 1 year.; Tablet taken orally once daily for up to 1 year
Intervention MeSH terms: Naltrexone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 436.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Alcoholism; Alcohol dependence

Summary:

      This was a Phase 3 multicenter randomized, open-label, safety study assessing the safety of
      repeat doses of Medisorb® naltrexone 380 mg (VIVITROL®) administered for up to 1 year to
      adults with alcohol and/or opioid dependence as defined by Diagnostic and Statistical Manual
      of Mental Health Disorders (DSM-IV) criteria. Eligible subjects were randomized in a 6:1
      ratio to receive 1 of the following regimens: a single intramuscular (IM) injection of
      VIVITROL administered once every 4 weeks or oral naltrexone 50 mg administered daily.
    

Eligibility criteria:

        Primary Inclusion Criteria:

          -  Current diagnosis of DSM-IV alcohol dependence and/or diagnosis of DSM-IV opiate
             dependence 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, family
             member, significant other)

        Primary Exclusion Criteria:

          -  Presence of opiates in the urine (as determined by urine drug test) on Day 0 prior to
             naltrexone treatment

          -  Clinically significant medical/psychological condition or abnormality at screening
             (ie, physical examination, electrocardiogram [ECG], hematology or blood chemistry
             evaluation, or urinalysis findings)

          -  Clinically significant active hepatitis or hepatic failure evidenced by 1 of the
             following: aspartate transaminase (AST) or alanine transaminase (ALT) higher than 3
             times the upper limit of normal (3xULN), hyperbilirubinemia (bilirubin >10% above
             ULN), creatine phosphokinase (CPK) higher than 10xULN, prolonged prothrombin
             time(international normalized ratio ≥1.7), ascites, or esophageal variceal disease

          -  Manifestation of suicidal ideation, psychotic symptoms (including significant violent
             behavior), or psychiatric disorders that would compromise ability to complete the
             study

          -  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 study
             drug dosing, or ongoing medical condition likely to require prescribed opiate therapy
             during 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 prior
             to Day 0 or anticipated need for gluteal injections during study period

          -  Intolerance and/or hypersensitivity to naltrexone, naloxone, or
             polylactide-co-polymers such as polylactide-co-glycolide (PLG)