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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00156936
Recruitment Status : Terminated (Business decision)
First Posted : September 12, 2005
Results First Posted : November 3, 2010
Last Update Posted : November 17, 2010
Information provided by:
Alkermes, Inc.

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.

Condition or disease Intervention/treatment Phase
Alcoholism Opiate Dependence Drug: Medisorb naltrexone 380 mg Drug: Oral naltrexone to Medisorb naltrexone 380 mg Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multi-Center Study to Evaluate the Long-Term Safety of Medisorb® Naltrexone
Study Start Date : August 2004
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Medisorb naltrexone 380 mg (VIVITROL) 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.
Other Names:
  • VIVITROL 380 mg
  • Naltrexone for extended-release injectable suspension

Experimental: Oral naltrexone to Medisorb naltrexone 380 mg (VIVITROL) 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.

Primary Outcome Measures :
  1. Number of Subjects Who Reported at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study. [ Time Frame: Up to 3 years ]
    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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00156936

Sponsors and Collaborators
Alkermes, Inc.
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Study Director: Bernard L. Silverman, MD Alkermes, Inc.

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Responsible Party: Bernard L. Silverman, MD / VP, Clinical Development, Alkermes, Inc. Identifier: NCT00156936    
Other Study ID Numbers: ALK21-006EXT
First Posted: September 12, 2005    Key Record Dates
Results First Posted: November 3, 2010
Last Update Posted: November 17, 2010
Last Verified: November 2010
Additional relevant MeSH terms:
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Opioid-Related Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents