ALK21-006: Long-Term Study of Medisorb® Naltrexone (VIVITROL®)

Last updated: December 27, 2010
Sponsor: Alkermes, Inc.
Overall Status: Completed

Phase

3

Condition

Alcohol Dependence

Alcohol Use Disorder

Substance Abuse

Treatment

N/A

Clinical Study ID

NCT01218997
ALK21-006
  • Ages > 18
  • All Genders

Study 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 and/or opioid dependence as defined by Diagnostic and Statistical Manual of Mental Health Disorders (DSM-IV) criteria. Eligible subjects were randomized in a 6:1 ratio to receive 1 of the following regimens: a single intramuscular (IM) injection of VIVITROL administered once every 4 weeks or oral naltrexone 50 mg administered daily.

Eligibility Criteria

Inclusion

Primary Inclusion Criteria:

  • Current diagnosis of DSM-IV alcohol dependence and/or diagnosis of DSM-IV opiatedependence 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, familymember, significant other)

Exclusion

Primary Exclusion Criteria:

  • Presence of opiates in the urine (as determined by urine drug test) on Day 0 prior tonaltrexone treatment

  • Clinically significant medical/psychological condition or abnormality at screening (ie, physical examination, electrocardiogram [ECG], hematology or blood chemistryevaluation, or urinalysis findings)

  • Clinically significant active hepatitis or hepatic failure evidenced by 1 of thefollowing: aspartate transaminase (AST) or alanine transaminase (ALT) higher than 3times the upper limit of normal (3xULN), hyperbilirubinemia (bilirubin >10% aboveULN), creatine phosphokinase (CPK) higher than 10xULN, prolonged prothrombintime(international normalized ratio ≥1.7), ascites, or esophageal variceal disease

  • Manifestation of suicidal ideation, psychotic symptoms (including significant violentbehavior), or psychiatric disorders that would compromise ability to complete thestudy

  • 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 studydrug dosing, or ongoing medical condition likely to require prescribed opiate therapyduring 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 priorto Day 0 or anticipated need for gluteal injections during study period

  • Intolerance and/or hypersensitivity to naltrexone, naloxone, orpolylactide-co-polymers such as polylactide-co-glycolide (PLG)

Study Design

Total Participants: 436
Study Start date:
August 01, 2003
Estimated Completion Date:
March 31, 2005

Study Description

Safety evaluations included physical examinations, electrocardiograms (ECGs), laboratory measures (including plasma concentrations of naltrexone and 6β-naltrexol), assessments of injection sites, and adverse events (AEs).

All subjects received psychosocial support at each study visit for the duration of the study, with interim telephone contact 2 weeks after each monthly visit.