ALK21-013: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) in Adults With Opioid Dependence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.
ClinicalTrials.gov Identifier:
NCT00678418
First received: May 14, 2008
Last updated: January 11, 2012
Last verified: January 2012
Results First Received: December 20, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Opiate Dependence
Interventions: Drug: VIVITROL® 380 mg
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
VIVITROL® 380 mg Single intramuscular (IM) injection administered every 4 weeks
Placebo Single intramuscular (IM) injection administered every 4 weeks

Participant Flow for 2 periods

Period 1:   Part A (Double Blind)
    VIVITROL® 380 mg     Placebo  
STARTED     126     124  
COMPLETED     67     47  
NOT COMPLETED     59     77  

Period 2:   Part B (Open Label)
    VIVITROL® 380 mg     Placebo  
STARTED     114 [1]   0  
COMPLETED     71     0  
NOT COMPLETED     43     0  
[1] All participants who received placebo in Part A were switched to open-label VIVITROL in Part B.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
VIVITROL® 380 mg Single intramuscular (IM) injection administered every 4 weeks
Placebo Single intramuscular (IM) injection administered every 4 weeks
Total Total of all reporting groups

Baseline Measures
    VIVITROL® 380 mg     Placebo     Total  
Number of Participants  
[units: participants]
  126     124     250  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     126     124     250  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  29.4  ± 4.8     29.7  ± 3.6     29.6  ± 4.2  
Gender  
[units: participants]
     
Female     13     17     30  
Male     113     107     220  
Region of Enrollment  
[units: participants]
     
Russian Federation     126     124     250  



  Outcome Measures
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1.  Primary:   Percentage (%) of Opioid-free Weeks Per Subject in Double-blind Period (Part A)   [ Time Frame: 20 weeks ]

2.  Secondary:   Days to Discontinuation During Part A   [ Time Frame: 168 days (24 weeks) ]

3.  Secondary:   Craving Score: Change From Baseline   [ Time Frame: Baseline to 6 months (24 weeks) ]

4.  Secondary:   Incidence of Subjects Who Relapsed to Physiologic Opioid Dependence During the 24-week Treatment Period (Part A)   [ Time Frame: 24 Weeks ]

5.  Secondary:   Change in Percentage of Self-reported Opioid-free Days From Baseline to Week 24   [ Time Frame: 24 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Bernard L. Silverman, MD
Organization: Alkermes, Inc.
phone: 1-781-609-6000
e-mail: bernard.silverman@alkermes.com


No publications provided by Alkermes, Inc.

Publications automatically indexed to this study:

Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT00678418     History of Changes
Other Study ID Numbers: ALK21-013
Study First Received: May 14, 2008
Results First Received: December 20, 2010
Last Updated: January 11, 2012
Health Authority: United States: Food and Drug Administration