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

This study has been terminated.
(Business decision)
Sponsor:
Information provided by:
Alkermes
ClinicalTrials.gov Identifier:
NCT00156936
First received: September 7, 2005
Last updated: November 5, 2010
Last verified: November 2010
  Purpose

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 Intervention Phase
Alcoholism
Opiate Dependence
Drug: Medisorb naltrexone 380 mg
Drug: Oral naltrexone to Medisorb naltrexone 380 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multi-Center Study to Evaluate the Long-Term Safety of Medisorb® Naltrexone

Resource links provided by NLM:


Further study details as provided by Alkermes:

Primary Outcome Measures:
  • Number of Subjects Who Reported at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study. [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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).


Enrollment: 108
Study Start Date: August 2004
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156936

Sponsors and Collaborators
Alkermes
Investigators
Study Director: Bernard L. Silverman, MD Alkermes
  More Information

No publications provided

Responsible Party: Bernard L. Silverman, MD / VP, Clinical Development, Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT00156936     History of Changes
Other Study ID Numbers: ALK21-006EXT
Study First Received: September 7, 2005
Results First Received: October 8, 2010
Last Updated: November 5, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alcoholism
Opioid-Related Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014