Extended Release Naltrexone for Treating Amphetamine Dependence in Iceland

This study has been completed.
Sponsor:
Collaborators:
Society of Alcoholism and other Addictions
Information provided by (Responsible Party):
Helen Pettinati, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT01100853
First received: April 7, 2010
Last updated: November 25, 2013
Last verified: November 2013
Results First Received: July 9, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Amphetamine Dependence
Intervention: Drug: VIVITROL injection and VIVITROL Placebo Injection , 24 weeks

  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 Injection, 24 Weeks Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
VIVITROL Placebo Injection, 24 Weeks Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)

Participant Flow:   Overall Study
    VIVITROL Injection, 24 Weeks     VIVITROL Placebo Injection, 24 Weeks  
STARTED     51     49  
COMPLETED     24     26  
NOT COMPLETED     27     23  
Lost to Follow-up                 11                 6  
Received <4 study injections                 10                 13  
Withdrawal by Subject                 6                 4  



  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 Injection, 24 Weeks Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
VIVITROL Placebo Injection, 24 Weeks Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
Total Total of all reporting groups

Baseline Measures
    VIVITROL Injection, 24 Weeks     VIVITROL Placebo Injection, 24 Weeks     Total  
Number of Participants  
[units: participants]
  51     49     100  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     51     49     100  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  31.51  ± 1.11     31.59  ± 1.34     31.55  ± 1  
Gender  
[units: participants]
     
Female     15     10     25  
Male     36     39     75  
Region of Enrollment  
[units: participants]
     
Iceland     51     49     100  



  Outcome Measures
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1.  Primary:   Number Negative Urines (Proportion Negative Urines)   [ Time Frame: 24 Weeks ]

2.  Primary:   Number Negative Urines (Proportion Negative Urines) Amphetamine   [ Time Frame: 24 weeks ]

3.  Secondary:   Amphetamine Craving Scale   [ Time Frame: 24 weeks ]

4.  Secondary:   Beck Depression Inventory   [ Time Frame: 24 weeks ]

5.  Secondary:   Risk Assessment Battery   [ Time Frame: 24 weeks ]

6.  Secondary:   Prior Admissions to Vogur Hospital   [ Time Frame: Baseline ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Dr. Helen Pettinati
Organization: University of Pennsylvania
phone: 215-222-3200 ext 139
e-mail: helenp@mail.med.upenn.edu


No publications provided


Responsible Party: Helen Pettinati, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT01100853     History of Changes
Other Study ID Numbers: 811095, P50DA012756, 2009-013647-10
Study First Received: April 7, 2010
Results First Received: July 9, 2013
Last Updated: November 25, 2013
Health Authority: United States: Food and Drug Administration