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

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alkermes, Inc.
• Treatments: Analgesics, Opioid; Naltrexone

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)