Status:
COMPLETED
ALK21-013: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) in Adults With Opioid Dependence
Lead Sponsor:
Alkermes, Inc.
Conditions:
Opiate Dependence
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 inp...
Detailed Description
Part A was a double-blind, randomized, placebo-controlled assessment of the efficacy and safety of 24 weeks of monthly treatment with VIVITROL compared to placebo in opioid-dependent adults. Subjects...
Eligibility Criteria
Inclusion
- Primary
- 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
- 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)
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00678418
Start Date
June 1 2008
End Date
November 1 2010
Last Update
February 10 2017
Active Locations (1)
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1
Ethics Committee within the Federal Authority for Healthcare and Social Development Regulation
Moscow, Russia, 109074