NCT00156936

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Alkermes, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcoholism
• Opiate Dependence

Interventions

Type	Name	Description
DRUG	Medisorb naltrexone 380 mg	Administered via intramuscular (IM) injection once every 4 weeks. Subjects in this dosing group also received this treatment throughout the base study.
DRUG	Oral naltrexone to Medisorb naltrexone 380 mg	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.

Timeline

• Start date: 2004-08-01
• Primary completion: 2007-01-01
• Completion: 2007-01-01
• First posted: 2005-09-12
• Last updated: 2010-11-17
• Results posted: 2010-11-03