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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01218997
Recruitment Status : Completed
First Posted : October 13, 2010
Results First Posted : December 13, 2010
Last Update Posted : January 4, 2011
Information provided by:
Alkermes, Inc.

October 8, 2010
October 13, 2010
November 8, 2010
December 13, 2010
January 4, 2011
August 2003
March 2005   (Final data collection date for primary outcome measure)
Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study [ Time Frame: up to 1 year ]
A TEAE was defined as any adverse event (AE) that started or worsened on or after the administration of the first dose of study medication through 30 days after the end of study treatment.
Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study. [ Time Frame: up to 1 year ]
A TEAE was defined as any adverse event (AE) that started or worsened on or after the start of study medication through the end of treatment.
Complete list of historical versions of study NCT01218997 on Archive Site
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ALK21-006: Long-Term Study of Medisorb® Naltrexone (VIVITROL®)
A Randomized, Open Label, Long-Term, Multi-Center Study of the Safety of Medisorb® Naltrexone
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.

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.

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Drug: Medisorb naltrexone 380 mg
    Administered via intramuscular (IM) injection once every 4 weeks for up to 1 year.
    Other Names:
    • VIVITROL® 380 mg
    • Naltrexone for extended-release injectable suspension
  • Drug: Oral naltrexone 50 mg
    Tablet taken orally once daily for up to 1 year
    Other Name: Revia®
  • Experimental: Medisorb naltrexone 380 mg (VIVITROL)
    Intervention: Drug: Medisorb naltrexone 380 mg
  • Active Comparator: Oral naltrexone 50 mg
    Intervention: Drug: Oral naltrexone 50 mg
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
March 2005
March 2005   (Final data collection date for primary outcome measure)

Primary Inclusion Criteria:

  • 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 Criteria:

  • 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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Bernard L. Silverman, MD / VP, Clinical Development, Alkermes, Inc.
Alkermes, Inc.
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Study Director: Bernard L. Silverman, MD Alkermes, Inc.
Alkermes, Inc.
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP