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

Last updated: June 8, 2017
Sponsor: Alkermes, Inc.
Overall Status: Completed

Phase

3

Condition

Alcohol Dependence

Alcohol Use Disorder

Substance Abuse

Treatment

N/A

Clinical Study ID

NCT01218958
ALK21-003
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Primary Inclusion Criteria:

  • Diagnosis of alcohol dependence based on Diagnostic and Statistical Manual of MentalDisorders, 4th Ed. (DSM-IV) criteria

  • Male or non-pregnant, non-lactating female

  • Able to provide TimeLine Follow-Back (TLFB) alcohol consumption information for 90-dayperiod before detoxification and/or screening

  • At least 2 episodes of heavy alcohol drinking per week during the 30 days beforedetoxification and/or screening

  • Negative urine toxicological screen for opiates on day of randomization

  • Noncustodial, stable residence and phone plus 1 contact with verifiable address andphone

Exclusion

Primary Exclusion Criteria:

  • Evidence of hepatic failure including: ascites, prolonged prothrombin time (PT) (international normalized ratio [INR] ≥1.7), bilirubin >10% above upper limit ofnormal (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 psychiatricdisorders that would compromise subject's ability to complete the study

  • Current dependence (within past year) per DSM-IV criteria to benzodiazepines, opioidsor cocaine

  • Use of benzodiazepines and/or Ambien® (zolpidem tartrate) within 7 days prior to firstdose of study medication

  • Greater than 7 days inpatient treatment for substance use disorders within 30 days ofrandomization

  • Use of any opioids and/or methadone within 14 days of screening, or likely requiringopioid therapy during study period

  • Use of oral naltrexone or disulfiram within 14 days of screening

  • Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, orpolylactide-co-glycolide (PLG)

Study Design

Total Participants: 624
Study Start date:
February 01, 2002
Estimated Completion Date:
September 30, 2003

Study 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, received 6 injections of study drug and completed all study visits) and continued to meet eligibility criteria were given the option to enroll in extension study ALK21-003EXT (NCT01218971). A second extension, Study ALK21-010 (NCT00156923), was conducted subsequent to ALK21-003EXT.