ALK21-021: A Safety Study of Medisorb® Naltrexone (VIVITROL®) Administered to Health Care Professionals

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: NCT00834080
Recruitment Status : Completed
First Posted : February 3, 2009
Results First Posted : July 29, 2013
Last Update Posted : July 29, 2013
Information provided by (Responsible Party):
Alkermes, Inc.

Brief Summary:
The purpose of this study is to determine the safety and tolerability of Medisorb® naltrexone (VIVITROL®) when administered over a period of 24 months to health care professionals who have a history of opioid dependence.

Condition or disease Intervention/treatment Phase
Opiate Dependence Drug: Medisorb naltrexone 380 mg Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Study of the Safety and Tolerability of VIVITROL Administered to Health Care Professionals Participating in an Extended Outpatient Treatment Program for Opioid Dependence
Study Start Date : March 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Medisorb naltrexone 380 mg (VIVITROL) Drug: Medisorb naltrexone 380 mg
Intramuscular (IM) injection administered once every 4 weeks for up to 2 years
Other Names:
  • VIVITROL 380 mg
  • Naltrexone for extended-release injectable suspension

Primary Outcome Measures :
  1. Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study. [ Time Frame: 2 years (Baseline to end of study) ]
    A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).

Information from the National Library of Medicine

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

Primary Inclusion Criteria:

  • Health care professional (eg, physician, osteopath, nurse, pharmacist)
  • 18 years of age or older
  • Enrolled or enrolling in an extended outpatient treatment program for opioid dependence
  • Women of childbearing potential must agree to use an approved method of contraception for the duration of the study

Primary Exclusion Criteria:

  • Pregnancy and/or lactation
  • Evidence of hepatic failure
  • Active hepatitis
  • Any psychiatric disorder that would compromise ability to complete study requirements
  • Recent history of suicidal ideation or attempt
  • Current dependence to any drugs other than prescription opioids or heroin, benzodiazepines, caffeine, marijuana, alcohol, or nicotine
  • Positive urine drug test or self-reported use of opioids, cocaine, or amphetamines at screening

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): NCT00834080

United States, California
Alkermes Clinical Study Site
Colton, California, United States, 92324
Alkermes Clinical Study Site
Oceanside, California, United States, 92056
United States, Florida
Alkermes Clinical Study Site
Lauderhill, Florida, United States, 33319
United States, Illinois
Alkermes Clinical Study Site
Hoffman Estates, Illinois, United States, 60194
United States, Missouri
Alkermes Clinical Study Site
St. Louis, Missouri, United States, 63109
United States, New York
Alkermes Clinical Study Site
Elmsford, New York, United States, 10523
United States, Ohio
Alkermes Clinical Study Site
Canton, Ohio, United States, 44718
United States, Pennsylvania
Alkermes Clinical Study Site
Philadelphia, Pennsylvania, United States, 19118
Alkermes Clinical Study Site
Philadelphia, Pennsylvania, United States, 19125
United States, Texas
Alkermes Clinical Study Site
Austin, Texas, United States, 78754
Alkermes Clinical Study Site
Dallas, Texas, United States, 75225
Sponsors and Collaborators
Alkermes, Inc.
Study Director: Bernard L. Silverman, MD Alkermes, Inc.

Responsible Party: Alkermes, Inc. Identifier: NCT00834080     History of Changes
Other Study ID Numbers: ALK21-021
First Posted: February 3, 2009    Key Record Dates
Results First Posted: July 29, 2013
Last Update Posted: July 29, 2013
Last Verified: May 2013

Keywords provided by Alkermes, Inc.:
opioid dependence
opioid-related disorders

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists