Status:
COMPLETED
ALK21-003: Study of Medisorb® Naltrexone (VIVITROL®) in Alcohol-Dependent Adults
Lead Sponsor:
Alkermes, Inc.
Conditions:
Alcoholism
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study conducted in subjects diagnosed with alcohol dependence as defined by the Diagnostic and Statistical Manual of Menta...
Detailed Description
All subjects received standardized biopsychosocial support therapy (BRENDA Approach \[Volpicelli, JR \[2001\]; Guilford Press: New York\]) at each visit. Subjects who completed this study (ie, receiv...
Eligibility Criteria
Inclusion
- Primary
- Diagnosis of alcohol dependence based on Diagnostic and Statistical Manual of Mental Disorders, 4th Ed. (DSM-IV) criteria
- Male or non-pregnant, non-lactating female
- Able to provide TimeLine Follow-Back (TLFB) alcohol consumption information for 90-day period before detoxification and/or screening
- At least 2 episodes of heavy alcohol drinking per week during the 30 days before detoxification and/or screening
- Negative urine toxicological screen for opiates on day of randomization
- Noncustodial, stable residence and phone plus 1 contact with verifiable address and phone
- Primary
Exclusion
- Evidence of hepatic failure including: ascites, prolonged prothrombin time (PT) (international normalized ratio \[INR\] ≥1.7), bilirubin \>10% above upper limit of normal (ULN) and/or esophageal variceal disease
- Active hepatitis and/or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) higher than 3xULN
- History of pancreatitis
- Major depression with suicidal ideation, psychosis, bipolar disorder, or psychiatric disorders that would compromise subject's ability to complete the study
- Current dependence (within past year) per DSM-IV criteria to benzodiazepines, opioids or cocaine
- Use of benzodiazepines and/or Ambien® (zolpidem tartrate) within 7 days prior to first dose of study medication
- Greater than 7 days inpatient treatment for substance use disorders within 30 days of randomization
- Use of any opioids and/or methadone within 14 days of screening, or likely requiring opioid therapy during study period
- Use of oral naltrexone or disulfiram within 14 days of screening
- Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or polylactide-co-glycolide (PLG)
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2003
Estimated Enrollment :
624 Patients enrolled
Trial Details
Trial ID
NCT01218958
Start Date
February 1 2002
End Date
September 1 2003
Last Update
July 11 2017
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