Back to resultsALK21-006EXT: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol- or Opioid-dependent Adults (Extension of Study ALK21-006 [NCT01218997])
Primary Purpose
Alcoholism, Opiate Dependence
Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Medisorb naltrexone 380 mg
Oral naltrexone to Medisorb naltrexone 380 mg
Sponsored by
About this trial
This is an interventional treatment trial for Alcoholism
Eligibility Criteria
Primary Inclusion Criteria: Adults with a diagnosis of alcohol and/or opioid dependence as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) who had satisfactorily completed Alkermes' Study ALK21-006 or other qualifying Medisorb naltrexone study Willing and able to return for scheduled clinic visits and study assessments Had a stable address Agreed to use a contraception for the duration of the study and for 1 month following the last dose if of childbearing potential Written informed consent Primary Exclusion Criteria: Pregnancy or lactation Terminated early from study drug in a previous Medisorb naltrexone clinical trial Any finding that, in the view of the investigator, would compromise the ability to fulfill the protocol visit schedule and/or visit requirements
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Medisorb naltrexone 380 mg (VIVITROL)
Oral naltrexone to Medisorb naltrexone 380 mg (VIVITROL)
Arm Description
Outcomes
Primary Outcome Measures
Number of Subjects Who Reported at Least 1 Treatment-emergent Adverse Event (TEAE) While on 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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00156936
Brief Title
ALK21-006EXT: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol- or Opioid-dependent Adults (Extension of Study ALK21-006 [NCT01218997])
Official Title
An Open-Label, Multi-Center Study to Evaluate the Long-Term Safety of Medisorb® Naltrexone
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Terminated
Why Stopped
Business decision
Study Start Date
August 2004 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Alkermes, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This was a multicenter extension of Alkermes' Study ALK21-006 (NCT01218997) designed to assess the long-term safety of repeat monthly doses of naltrexone long-acting injection. All subjects received open-label Medisorb® naltrexone 380 mg (VIVITROL®).
Planned treatment duration was up to 3 years. Alkermes terminated the study for business purposes in December 2006. The median duration of treatment among all subjects in this extension study was 43 weeks.
Detailed Description
From the date of successful completion of Study ALK21-006 (base study [NCT01218997])), all subjects, including those who received oral naltrexone during the base study, were given the option to enroll in this extension study.
Study investigators ensured that subjects were opioid-free and did not demonstrate evidence of withdrawal prior to administration of VIVITROL therapy. If the investigator suspected recent clinically significant opioid use, a naloxone challenge test was performed. The naloxone challenge was not performed in a subject presenting clinical signs or symptoms of opioid withdrawal or in a subject whose urine contained opioids.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism, Opiate Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Medisorb naltrexone 380 mg (VIVITROL)
Arm Type
Experimental
Arm Title
Oral naltrexone to Medisorb naltrexone 380 mg (VIVITROL)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Medisorb naltrexone 380 mg
Other Intervention Name(s)
VIVITROL 380 mg, Naltrexone for extended-release injectable suspension
Intervention Description
Administered via intramuscular (IM) injection once every 4 weeks. Subjects in this dosing group also received this treatment throughout the base study.
Intervention Type
Drug
Intervention Name(s)
Oral naltrexone to Medisorb naltrexone 380 mg
Intervention Description
Subjects in this dosing group received oral naltrexone 50 mg in the base study, but received only Medisorb naltrexone 380 mg in this extension study, administered via IM injection once every 4 weeks.
Primary Outcome Measure Information:
Title
Number of Subjects Who Reported at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study.
Description
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).
Time Frame
Up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Primary Inclusion Criteria:
Adults with a diagnosis of alcohol and/or opioid dependence as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) who had satisfactorily completed Alkermes' Study ALK21-006 or other qualifying Medisorb naltrexone study
Willing and able to return for scheduled clinic visits and study assessments
Had a stable address
Agreed to use a contraception for the duration of the study and for 1 month following the last dose if of childbearing potential
Written informed consent
Primary Exclusion Criteria:
Pregnancy or lactation
Terminated early from study drug in a previous Medisorb naltrexone clinical trial
Any finding that, in the view of the investigator, would compromise the ability to fulfill the protocol visit schedule and/or visit requirements
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard L. Silverman, MD
Organizational Affiliation
Alkermes, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
ALK21-006EXT: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol- or Opioid-dependent Adults (Extension of Study ALK21-006 [NCT01218997])
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