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

• Status: Terminated
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alkermes, Inc.
• Treatments: Naltrexone

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