ALK21-003: Study of Medisorb® Naltrexone (VIVITROL®) in Alcohol-Dependent Adults
Condition: Alcoholism
MeSH terms: Alcoholism
Intervention: Medisorb naltrexone 190 mg; Medisorb naltrexone 380 mg; Placebo matching Medisorb naltrexone 190 mg; Placebo matching Medisorb naltrexone 380 mg
Intervention description: Intramuscular (IM) injection once every 4 weeks for a total of 6 administrations.; IM injection once every 4 weeks for a total of 6 administrations.; IM injection once every 4 weeks for a total of 6 administrations.; IM injection once every 4 weeks for a total of 6 administrations.
Intervention MeSH terms: Naltrexone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 624.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Alcoholism

Summary:

      This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study conducted
      in subjects diagnosed with alcohol dependence as defined by the Diagnostic and Statistical
      Manual of Mental Disorders, 4th Ed. (DSM-IV). Subjects were randomized (2:2:1:1) to receive
      intramuscular (IM) injections of Medisorb® naltrexone 190 mg, Medisorb naltrexone 380 mg,
      placebo for Medisorb naltrexone 190 mg, or placebo for Medisorb naltrexone 380 mg
      (VIVITROL®). Study drug was administered every 4 weeks for a total of 6 injections.
    

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)