Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.
ClinicalTrials.gov Identifier:
NCT00834080
First received: February 2, 2009
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Opiate Dependence
Drug: Medisorb naltrexone 380 mg
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Alkermes, Inc.:

Primary Outcome Measures:
  • 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).


Enrollment: 38
Study Start Date: March 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00834080

Locations
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.
Investigators
Study Director: Bernard L. Silverman, MD Alkermes, Inc.
  More Information

No publications provided

Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT00834080     History of Changes
Other Study ID Numbers: ALK21-021
Study First Received: February 2, 2009
Results First Received: May 30, 2013
Last Updated: May 30, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Naltrexone
Central Nervous System Agents
Narcotic Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014