ALK21-006EXT: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol- or Opioid-dependent Adults (Extension of Study ALK21-006 [NCT01218997])

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Open-Label, Multi-Center Study to Evaluate the Long-Term Safety of Medisorb® Naltrexone

Conditions
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Alcoholism, Opiate Dependence

Intervention / Treatment
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* Drug: Medisorb naltrexone 380 mg
* Drug: Oral naltrexone to Medisorb naltrexone 380 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medisorb naltrexone 380 mg (VIVITROL)<br> | Drug: Medisorb naltrexone 380 mg<br>* Administered via intramuscular (IM) injection once every 4 weeks. Subjects in this dosing group also received this treatment throughout the base study.<br>* Other names: Naltrexone for extended-release injectable suspension;|
| Experimental: Oral naltrexone to Medisorb naltrexone 380 mg (VIVITROL)<br> | Drug: Oral naltrexone to Medisorb naltrexone 380 mg<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Up to 3 years |