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

• Percent heavy drinking days [ Time Frame: up to 12 months ]
• Percent days abstinent [ Time Frame: up to 12 months ]
• Days to first drinking day [ Time Frame: up to 12 months ]
• Days to first heavy drinking day [ Time Frame: up to 12 months ]
• Obsessive-Compulsive Drinking Scale scores [ Time Frame: up to 12 months ]
• Gamma glutamyl-transferase levels [ Time Frame: up to 12 months ]

VIVITROL is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. This Phase 3B trial was designed to evaluate the efficacy and safety of VIVITROL versus placebo. Injections were administered to patients in whom abstinence was enforced by a period of inpatient hospitalization of 7 to 21 days.

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.

• Drug: VIVITROL 380 mg
  Administered via IM injection once every 4 weeks.
  Other Names:

  • naltrexone for extended-release injectable suspension
  • Medisorb naltrexone
• Drug: Placebo for VIVITROL 380 mg
  Administered via IM injection once every 4 weeks.

• Active Comparator: VIVITROL 380 mg
  Administered via intramuscular (IM) injection once every 4 weeks.
  Intervention: Drug: VIVITROL 380 mg
• Placebo Comparator: Placebo for VIVITROL 380 mg
  Administered via IM injection once every 4 weeks.
  Intervention: Drug: Placebo for VIVITROL 380 mg

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