ALK21-014: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) After Enforced Abstinence

The study consisted of 2 parts, Part A and Part B. Part A was a double-blind, placebo-controlled assessment of safety and efficacy of VIVITROL versus placebo for 3 months. Part B was an open-label extension to assess longer-term safety, durability of effect, and health economics of VIVITROL when administered for up to 9 additional months.

Primary Inclusion Criteria:

• Current diagnosis of alcohol dependence, meeting at least 5 of DSM-IV criteria
• Expected to complete inpatient treatment for alcohol dependence within 24 hours of randomization
• Must have 7-21 days, inclusive, of inpatient treatment for alcohol dependence prior to first dose
• Negative urine toxicological screen for opioids on the day of randomization
• Women of childbearing potential must agree to use an approved method of contraception for the study duration

Primary Exclusion Criteria:

• Pregnancy or lactation
• Evidence of hepatic failure including: ascites, bilirubin >10% above upper limit of normal and/or esophageal variceal disease
• Current dependence (within the past year) to benzodiazepines, opioids or cocaine by DSM-IV criteria
• Use of any opioids and/or methadone within 14 days prior to the screening visit, or subjects likely to require opioid therapy during the study period
• Use of oral naltrexone, acamprosate, or disulfiram within 14 days prior to screening
• Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or PLG
• Parole, probation, or pending legal proceedings having the potential for incarceration during the study period