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

NCT00156936 | Terminated Phase 3 Results

• 1 other identifier: ALK21-006EXT
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Alcoholism; Opiate Dependence

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Medisorb naltrexone 380 mg (VIVITROL)

EXPERIMENTAL

Drug: Medisorb naltrexone 380 mg

Oral naltrexone to Medisorb naltrexone 380 mg (VIVITROL)

EXPERIMENTAL

Drug: Oral naltrexone to Medisorb naltrexone 380 mg

Interventions

Medisorb naltrexone 380 mg DRUG

Administered via intramuscular (IM) injection once every 4 weeks. Subjects in this dosing group also received this treatment throughout the base study.

Also known as: VIVITROL 380 mg, Naltrexone for extended-release injectable suspension

Medisorb naltrexone 380 mg (VIVITROL)

Oral naltrexone to Medisorb naltrexone 380 mg DRUG

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.

Oral naltrexone to Medisorb naltrexone 380 mg (VIVITROL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alkermes, Inc.: lead

MeSH Terms

Conditions

Alcoholism; Opioid-Related Disorders

Interventions

vivitrol; Naltrexone

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Bernard L. Silverman / VP, Clinical Development
• Organization: Alkermes, Inc.

bernard.silverman@alkermes.com

781-609-6000

Study Officials

• Bernard L. Silverman, MD

  Alkermes, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 12, 2005
• Study Start: August 1, 2004
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: November 17, 2010
• Results First Posted: November 3, 2010

Record last verified: 2010-11