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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: December 21, 2016
Last verified: December 2016
Results First Received: December 20, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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.
No text entered.

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 
Overall Participants Analyzed 
[Units: Participants]
 126   124   250 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      126 100.0%      124 100.0%      250 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 29.4  (4.8)   29.7  (3.6)   29.6  (4.2) 
Gender 
[Units: Participants]
Count of Participants
     
Female      13  10.3%      17  13.7%      30  12.0% 
Male      113  89.7%      107  86.3%      220  88.0% 
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


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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: December 21, 2016