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Drug Treatment for Pathologic Gambling Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00053677
First Posted: February 5, 2003
Last Update Posted: October 3, 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 Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Jon Grant, University of Chicago
Results First Submitted: April 3, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Gambling
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
83 participants began the placebo lead-in phase. 6 of those were placebo responders. The remaining 77 were randomized to Naltrexone or placebo.

Reporting Groups
  Description
Naltrexone

17 weeks of double-blind Naltrexone. Subjects were randomized into one of these three conditions (if they weren't randomized to placebo): naltrexone 50mg/day, 100mg/day, 150mg/day. To minimize nausea, treatment for all subjects was initiated at 25mg/day naltrexone for two days, then the dose was increased to 50mg/day. At week 3, subjects were randomly assigned to 50mg/day continued at that dose, while subjects who were randomized to naltrexone 100mg/day or 150mg/day were raised to the higher doses.

Naltrexone: For subjects who were randomly assigned to naltrexone 50mg/day, 100mg/day, or 150mg/day.

Placebo

Subjects who were assigned to placebo in the 17 week double-blind phase.

Placebo: For subjects who were randomly assigned to placebo.


Participant Flow:   Overall Study
    Naltrexone   Placebo
STARTED   58   19 
COMPLETED   36   13 
NOT COMPLETED   22   6 



  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

17 weeks of double-blind Naltrexone. Subjects were randomized into one of these three conditions (if they weren't randomized to placebo): naltrexone 50mg/day, 100mg/day, 150mg/day. To minimize nausea, treatment for all subjects was initiated at 25mg/day naltrexone for two days, then the dose was increased to 50mg/day. At week 3, subjects were randomly assigned to 50mg/day continued at that dose, while subjects who were randomized to naltrexone 100mg/day or 150mg/day were raised to the higher doses.

Naltrexone: For subjects who were randomly assigned to naltrexone 50mg/day, 100mg/day, or 150mg/day.

Placebo

Subjects who were assigned to placebo in the 17 week double-blind phase.

Placebo: For subjects who were randomly assigned to placebo.

Total Total of all reporting groups

Baseline Measures
   Naltrexone   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 58   19   77 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.8  (9.65)   44.7  (9.67)   46.3  (9.66) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female   37   10   47 
Male   21   9   30 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Race/Ethnicity       
White   54   16   70 
Other Race   4   3   7 
Region of Enrollment 
[Units: Participants]
     
United States   58   19   77 


  Outcome Measures

1.  Primary:   Yale-Brown Obsessive Compulsive Scale for Pathological Gambling (PG-YBOCS)   [ Time Frame: 18 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
Pathological gambling is a chronic disease that may require long-term therapy. Although this study is one of the longest medication trials for PG, the study did not assess treatment effects beyond the acute 18-week treatment period.


  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. Jon E. Grant
Organization: University of Chicago
phone: 773-834-1325
e-mail: jongrant@uchicago.edu


Publications:

Responsible Party: Jon Grant, University of Chicago
ClinicalTrials.gov Identifier: NCT00053677     History of Changes
Other Study ID Numbers: R21MH065920 ( U.S. NIH Grant/Contract )
DSIR AT-AS
First Submitted: February 4, 2003
First Posted: February 5, 2003
Results First Submitted: April 3, 2017
Results First Posted: October 3, 2017
Last Update Posted: October 3, 2017