Status:
TERMINATED
ALK21-006EXT: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol- or Opioid-dependent Adults (Extension of Study ALK21-006 [NCT01218997])
Lead Sponsor:
Alkermes, Inc.
Conditions:
Alcoholism
Opiate Dependence
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 o...
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 enro...
Eligibility Criteria
Inclusion
- Primary
- 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
- 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
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00156936
Start Date
August 1 2004
End Date
January 1 2007
Last Update
November 17 2010
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