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Double-Blind Naltrexone in Kleptomania

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jon E. Grant, University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00332579
First received: May 30, 2006
Last updated: April 9, 2012
Last verified: April 2012
History of Changes
Results First Received: March 1, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Kleptomania
Interventions: Drug: Naltrexone
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
Naltrexone Naltrexone 50mg tablets taken daily. Dose range from 50mg-150mg by mouth daily. Started at 50mg and then titrated up based upon investigator discretion.
Placebo Placebo tablets (identical to naltrexone pills) taken by mouth daily.

Participant Flow:   Overall Study
    Naltrexone     Placebo  
STARTED     12     13  
COMPLETED     11     12  
NOT COMPLETED     1     1  



  Baseline Characteristics
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Reporting Groups
  Description
Naltrexone Naltrexone 50mg tablets taken daily. Dose range from 50mg-150mg by mouth daily. Started at 50mg and then titrated up based upon investigator discretion.
Placebo Placebo tablets (identical to naltrexone pills) taken by mouth daily.
Total Total of all reporting groups

Baseline Measures
    Naltrexone     Placebo     Total  
Number of Participants  
[units: participants]
 		  12     13     25  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     12     13     25  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  44.3  ± 12.2     41.4  ± 12.7     42.6  ± 12.4  
Gender  
[units: participants]
 		     
Female     8     10     18  
Male     4     3     7  
Region of Enrollment  
[units: participants]
 		     
United States     12     13     25  



  Outcome Measures

1.  Primary:   Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (K-YBOCS)   [ Time Frame: K-YBOCS is done at each visit by the investigator. ]
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  Serious Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
Naltrexone Naltrexone 50mg tablets taken daily. Dose range from 50mg-150mg by mouth daily. Started at 50mg and then titrated up based upon investigator discretion.
Placebo Placebo tablets (identical to naltrexone pills) taken by mouth daily.

Serious Adverse Events
    Naltrexone     Placebo  
Total, serious adverse events      
# participants affected / at risk     0/13 (0.00%)     0/12 (0.00%)  




  Other Adverse Events
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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.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: Jon E. Grant
Organization: University of Minnesota
phone: 612-273-9800
e-mail: grant045@umn.edu


No publications provided by University of Minnesota - Clinical and Translational Science Institute

Publications automatically indexed to this study:


Responsible Party: Jon E. Grant, University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00332579     History of Changes
Other Study ID Numbers: 0602M82626
Study First Received: May 30, 2006
Results First Received: March 1, 2012
Last Updated: April 9, 2012
Health Authority: United States: Institutional Review Board