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

Alcoholism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00156936
• Other study ID #: ALK21-006EXT
• Status: Terminated
• Phase: Phase 3
• First received: September 7, 2005
• Last updated: November 5, 2010
• Start date: August 2004
• Est. completion date: January 2007

Study information

• Verified date: November 2010
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 108
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism
• Opiate Dependence

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No