ALK21-003: Study of Medisorb® Naltrexone (VIVITROL®) in Alcohol-Dependent Adults

• Status: Completed
• Trial end date: 2003-09-01
• Target enrollment: 0
• Participant gender: All

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 Mental Disorders, 4th Ed. (DSM-IV). Subjects were randomized (2:2:1:1) to receive intramuscular (IM) injections of Medisorb® naltrexone 190 mg, Medisorb naltrexone 380 mg, placebo for Medisorb naltrexone 190 mg, or placebo for Medisorb naltrexone 380 mg (VIVITROL®). Study drug was administered every 4 weeks for a total of 6 injections.

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

Details

• Lead Sponsor: Alkermes, Inc.
• Treatments: Naltrexone

Criteria

Primary Inclusion Criteria:

• 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 Criteria:

• 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)