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.

Brief 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.

Condition or disease Intervention/treatment Phase
Alcoholism Drug: Medisorb naltrexone 380 mg Drug: Oral naltrexone 50 mg Phase 3

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 436 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open Label, Long-Term, Multi-Center Study of the Safety of Medisorb® Naltrexone
Study Start Date : August 2003
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Medisorb naltrexone 380 mg (VIVITROL) 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
Active Comparator: Oral naltrexone 50 mg Drug: Oral naltrexone 50 mg
Tablet taken orally once daily for up to 1 year
Other Name: Revia®

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01218997

Sponsors and Collaborators
Alkermes, Inc.
Study Director: Bernard L. Silverman, MD Alkermes, Inc.

Responsible Party: Bernard L. Silverman, MD / VP, Clinical Development, Alkermes, Inc. Identifier: NCT01218997     History of Changes
Other Study ID Numbers: ALK21-006
First Posted: October 13, 2010    Key Record Dates
Results First Posted: December 13, 2010
Last Update Posted: January 4, 2011
Last Verified: December 2010

Keywords provided by Alkermes, Inc.:
Alcohol dependence

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents