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Investigation of Naltrexone for Pathological Gambling

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01057862
First Posted: January 27, 2010
Last Update Posted: September 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Center for Responsible Gaming
Information provided by (Responsible Party):
Marc Potenza, Yale University
Results First Submitted: January 11, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pathological Gambling
Interventions: Drug: Naltrexone
Other: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment was dependent on referrals from several gambling related clinics in the state of CT and unfortunately there were very few referrals causing the study to end with much lower numbers of study subjects than anticipated.

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
Naltrexone Naltrexone: Targeted dosage of 50mg PO daily
Placebo No text entered.

Participant Flow:   Overall Study
    Naltrexone   Placebo
STARTED   5   4 
COMPLETED   4   2 
NOT COMPLETED   1   2 
Withdrawal by Subject                1                2 



  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
Naltrexone Naltrexone: Targeted dosage of 50mg PO daily
Placebo Placebo
Total Total of all reporting groups

Baseline Measures
   Naltrexone   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   4   9 
Age 
[Units: Years]
Mean (Standard Deviation)
 57  (9.9)   52.75  (9)   55.11  (9.17) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1  20.0%      0   0.0%      1  11.1% 
Male      4  80.0%      4 100.0%      8  88.9% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (YBOCS-PG)   [ Time Frame: Weekly/bi-weekly visits ]

2.  Secondary:   Gambling Symptom Assessment Scale (G-SAS)   [ Time Frame: Weekly/bi-weekly visits ]


  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
Enrollment was lower than expected and due to the low numbers of subjects completing the study (7 subjects completed all interventions) the numbers were not powerful enough to conduct a full analysis or provide any meaningful statistical analyses.


  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. Marc N Potenza
Organization: Yale University
phone: 2037373553
e-mail: marc.potenza@yale.edu


Publications:


Responsible Party: Marc Potenza, Yale University
ClinicalTrials.gov Identifier: NCT01057862     History of Changes
Other Study ID Numbers: 0901004667
NCRG CORE R09240
First Submitted: January 25, 2010
First Posted: January 27, 2010
Results First Submitted: January 11, 2017
Results First Posted: September 12, 2017
Last Update Posted: September 12, 2017



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