ALK21-006EXT: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol- or Opioid-dependent Adults (Extension of Study ALK21-006 [NCT01218997])
Information source: Alkermes, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alcoholism; Opiate Dependence
Intervention: Medisorb naltrexone 380 mg (Drug); Oral naltrexone to Medisorb naltrexone 380 mg (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Alkermes, Inc. Official(s) and/or principal investigator(s): Bernard L. Silverman, MD, Study Director, Affiliation: Alkermes, Inc.
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.
Clinical Details
Official title: An Open-Label, Multi-Center Study to Evaluate the Long-Term Safety of Medisorb® Naltrexone
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of Subjects Who Reported at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: August 2004
Last updated: November 5, 2010
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