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

This study has been completed.
Information provided by (Responsible Party):
Alkermes, Inc. Identifier:
First received: February 2, 2009
Last updated: May 30, 2013
Last verified: May 2013

February 2, 2009
May 30, 2013
March 2009
May 2012   (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: 2 years (Baseline to end of study) ] [ Designated as safety issue: No ]
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).
Incidence of adverse events [ Time Frame: 25 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00834080 on Archive Site
Not Provided
  • Length of time on study drug [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Rate of opioid-negative urine drug tests [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Incidence of opioid detoxification occuring within the study period [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Change in employment status and professional licensure [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
ALK21-021: A Safety Study of Medisorb® Naltrexone (VIVITROL®) Administered to Health Care Professionals
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
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.
Not Provided
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Opiate Dependence
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
Experimental: Medisorb naltrexone 380 mg (VIVITROL)
Intervention: Drug: Medisorb naltrexone 380 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2012
May 2012   (final data collection date for primary outcome measure)

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
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Alkermes, Inc.
Alkermes, Inc.
Not Provided
Study Director: Bernard L. Silverman, MD Alkermes, Inc.
Alkermes, Inc.
May 2013

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