Status:
COMPLETED
ALK21-006: Long-Term Study of Medisorb® Naltrexone (VIVITROL®)
Lead Sponsor:
Alkermes, Inc.
Conditions:
Alcoholism
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This was a Phase 3 multicenter randomized, open-label, safety study assessing the safety of repeat doses of Medisorb® naltrexone 380 mg (VIVITROL®) administered for up to 1 year to adults with alcohol...
Detailed Description
Safety evaluations included physical examinations, electrocardiograms (ECGs), laboratory measures (including plasma concentrations of naltrexone and 6β-naltrexol), assessments of injection sites, and ...
Eligibility Criteria
Inclusion
- Primary
- Current diagnosis of DSM-IV alcohol dependence and/or diagnosis of DSM-IV opiate dependence within 3 months prior to screening
- 18 years or older
- Desire to seek treatment for alcohol and/or opiate abuse/dependence
- Agree to use contraception for the study duration if of childbearing potential
- Written informed consent and willingness to perform study procedures
- Stable address and phone and at least 1 source of contact information (eg, family member, significant other)
- Primary
Exclusion
- Presence of opiates in the urine (as determined by urine drug test) on Day 0 prior to naltrexone treatment
- Clinically significant medical/psychological condition or abnormality at screening (ie, physical examination, electrocardiogram \[ECG\], hematology or blood chemistry evaluation, or urinalysis findings)
- Clinically significant active hepatitis or hepatic failure evidenced by 1 of the following: aspartate transaminase (AST) or alanine transaminase (ALT) higher than 3 times the upper limit of normal (3xULN), hyperbilirubinemia (bilirubin \>10% above ULN), creatine phosphokinase (CPK) higher than 10xULN, prolonged prothrombin time(international normalized ratio ≥1.7), ascites, or esophageal variceal disease
- Manifestation of suicidal ideation, psychotic symptoms (including significant violent behavior), or psychiatric disorders that would compromise ability to complete the study
- Participation in a formal methadone program currently or within prior 3 years
- More than 2 prior medically supervised detoxification treatments in prior 3 years
- Pregnancy or lactation
- Current prescribed opiate therapy, or receipt of opiates within 7 days prior to study drug dosing, or ongoing medical condition likely to require prescribed opiate therapy during study period
- Failed naloxone challenge on Day 0 (the challenge could be repeated up to 2 times, with at least 24 hours between attempts)
- Participation in a clinical trial within 30 days of screening
- Previous enrollment in a VIVITROL clinical trial
- Receipt of any drug product administered as a gluteal injection within 180 days prior to Day 0 or anticipated need for gluteal injections during study period
- Intolerance and/or hypersensitivity to naltrexone, naloxone, or polylactide-co-polymers such as polylactide-co-glycolide (PLG)
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
436 Patients enrolled
Trial Details
Trial ID
NCT01218997
Start Date
August 1 2003
End Date
March 1 2005
Last Update
January 4 2011
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