ALK21-013: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) in Adults With Opioid Dependence

Primary Inclusion Criteria:

- Written, informed consent

- 18 years of age or older

- Current diagnosis of opioid dependence, based on Diagnostic and Statistical Manual
of Mental Health Disorders, 4th Ed. (DSM-IV-TR) criteria

- Voluntarily seeking treatment for opioid dependence

- Completing or recently completed up to 30 days of inpatient treatment for opioid
detoxification, and off all opioids (including buprenorphine and methadone) for at
least 7 days

- Noncustodial, stable residence and phone, plus 1 contact with verifiable address and
phone

- Significant other (eg, spouse, relative) willing to supervise compliance with the
study visit schedule and procedures

- Agree to use contraception for study duration if of childbearing potential

Primary Exclusion Criteria:

- Pregnancy or lactation

- Clinically significant medical condition or observed abnormalities (eg: physical
exam, electrocardiogram (ECG), lab and/or urinalysis findings)

- Positive naloxone challenge test at randomization (Day 0)

- Evidence of hepatic failure including: ascites, bilirubin >10% above upper limit of
normal (ULN) and/or esophageal variceal disease

- Past or present history of an acquired immunodeficiency syndrome (AIDS)-indicator
disease in HIV-infected subjects

- Active hepatitis and/or aspartate aminotransferase (AST), alanine
aminotransferase(ALT) >3xULN

- Current major depression with suicidal ideation, psychosis, bipolar disorder, or any
psychiatric disorder that would compromise ability to complete the study

- Recent history (within 6 months prior to screening) of suicidal ideation or attempt

- Dependence within prior year based on DSM-IV-TR, to any drugs other than
prescription opioids or heroin, caffeine, marijuana, or nicotine

- Active alcohol dependence within prior 6 months

- Current alcohol use disorder that would, in the Investigator's opinion, preclude
successful completion of the study

- Positive urine drug test for cocaine, benzodiazepines, or amphetamines at screening

- Use of oral naltrexone for 7 consecutive days within 60 days prior to screening

- Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or
polylactide-co-glycolide (PLG)