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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00834080
First Posted: February 3, 2009
Last Update Posted: July 29, 2013
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.
Information provided by (Responsible Party):
Alkermes, Inc.
February 2, 2009
February 3, 2009
May 30, 2013
July 29, 2013
July 29, 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) ]
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 ]
Complete list of historical versions of study NCT00834080 on ClinicalTrials.gov Archive Site
Not Provided
  • Length of time on study drug [ Time Frame: 24 Months ]
  • Rate of opioid-negative urine drug tests [ Time Frame: 24 Months ]
  • Incidence of opioid detoxification occuring within the study period [ Time Frame: 24 Months ]
  • Change in employment status and professional licensure [ Time Frame: 24 Months ]
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
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00834080
ALK21-021
No
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