Phase 3
Completed N=250
ALK21-013: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) in Adults With Opioid Dependence
Opiate Dependence
Source: ClinicalTrials.gov NCT00678418 ↗
Enrolled (actual)
250
Serious AEs
2.8%
Results posted
Jan 2011
Primary outcomePrimary: Percentage (%) of Opioid-free Weeks Per Subject in Double-blind Period (Part A) — 90.0; 35.0 Percentage of opioid-free weeks — p=0.0002
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage (%) of Opioid-free Weeks Per Subject in Double-blind Period (Part A) |
90.0; 35.0 | 0.0002 sig |
| SECONDARY Days to Discontinuation During Part A |
NA; 96.0 | 0.0042 sig |
| SECONDARY Craving Score: Change From Baseline |
-10.087; 0.654 | <0.0001 sig |
| SECONDARY Incidence of Subjects Who Relapsed to Physiologic Opioid Dependence During the 24-week Treatment Period (Part A) |
46.8; 62.1 | 0.0154 sig |
| SECONDARY Change in Percentage of Self-reported Opioid-free Days From Baseline to Week 24 |
75.83; 46.43 | 0.0031 sig |
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)
Data sourced from ClinicalTrials.gov (NCT00678418). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.