ALK21-013: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) in Adults With Opioid Dependence
Condition: Opiate Dependence
MeSH terms: Opioid-Related Disorders
Intervention: VIVITROL® 380 mg; Placebo
Intervention description: Administered via intramuscular (IM) injection once every 4 weeks for 24 weeks during Part A, followed by once every 4 weeks for 52 weeks in Part B.; Administered via IM injection once every 4 weeks for 24 weeks during Part A, followed by VIVITROL® 380 mg via IM injection once every 4 weeks for 52 weeks in Part B.
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: 250.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Addiction; Opiate dependence; Inpatient detoxification; opioid dependence; heroin dependence

Summary:

      This is a Phase 3 multi-center trial designed to evaluate the clinical efficacy and safety of
      VIVITROL® (Medisorb® naltrexone 380 mg) versus placebo when administered to adults upon
      discharge from inpatient treatment for opioid dependence.

      The study was conducted in 2 parts, Part A and Part B. The clinical portion of both parts has
      completed. Results for Part B are not yet available.
    

Eligibility criteria:

        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)