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Investigation of Naltrexone for Pathological Gambling

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ClinicalTrials.gov Identifier: NCT01057862
Recruitment Status : Completed
First Posted : January 27, 2010
Results First Posted : September 12, 2017
Last Update Posted : October 13, 2017
Sponsor:
Collaborator:
National Center for Responsible Gaming
Information provided by (Responsible Party):
Yale University

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
Enrollment 9
Recruitment Details 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  
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description Naltrexone: Targeted dosage of 50mg PO daily [Not Specified]
Period Title: Overall Study
Started 5 4
Completed 4 2
Not Completed 1 2
Reason Not Completed
Withdrawal by Subject             1             2
Arm/Group Title Naltrexone Placebo Total
Hide Arm/Group Description Naltrexone: Targeted dosage of 50mg PO daily Placebo Total of all reporting groups
Overall Number of Baseline Participants 5 4 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 4 participants 9 participants
57  (9.9) 52.75  (9) 55.11  (9.17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 9 participants
Female
1
  20.0%
0
   0.0%
1
  11.1%
Male
4
  80.0%
4
 100.0%
8
  88.9%
1.Primary Outcome
Title Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (YBOCS-PG)
Hide Description The Yale Brown Obsessive Compulsive Scale adapted for Pathological Gambling (PG-YBOCS) was developed to measure the severity and change in severity of pathological gambling symptoms.The PG-YBOCS is a 10-item clinician-administered questionnaire that measures the severity of PG over a specified time interval. Scores of 0 through 4 are assigned to each question according to the severity of the response (0 = least severe response, 4 = most severe response). The first five questions assess urges and thoughts associated with pathological gambling, whereas the last five questions assess the behavioral component of the disorder. Each set of questions is totaled separately as well as together for a total score. The total score can range from 0 (low) to 40 (most severe) with higher numbers representing a more severe form of pathological gambling.
Time Frame Weekly/bi-weekly visits
Hide Outcome Measure Data
Hide Analysis Population Description
Enrollment was lower than expected and due to the low numbers of subjects completing the study (7 subjects completed all interventions - 5 naltrexone and 2 placebo) the numbers were not powerful enough to conduct a full analysis or provide any meaningful statistical analyses.
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description:
Naltrexone: Targeted dosage of 50mg PO daily
Placebo
Overall Number of Participants Analyzed 5 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 5 participants 4 participants
16.0  (7.35) 17.0  (13.54)
End of Study Number Analyzed 5 participants 2 participants
10.0  (9.35) 4.0  (5.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naltrexone
Comments Enrollment was lower than expected and due to the low numbers of subjects completing the study (7 subjects (5 active and 2 placebo) completed all interventions) the numbers were not powerful enough to conduct a full analysis or provide any meaningful statistical analyses. We are including the mean and SD of each arm at the beginning and end of the study only as a comparison and not as a meaningful analysis.
Type of Statistical Test Other
Comments We are including the mean and SD of each arm at the start and end of study only as a comparison and not a meaningful analysis. Since higher scores represent a more severe form of the disorder, a drop in scores is seen as an indicator that the treatment had an effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6
Parameter Dispersion
Type: Standard Deviation
Value: 9.35
Estimation Comments The active arm had a mean PG-YBOCS score of 16 (n=5) at study start with a SD of 7.35. At end of study the active arm had a mean PG-YBOCS score of 10 (n=5) with a SD of 9.35. The placebo arm is not included here as there were only two scores.
2.Secondary Outcome
Title Gambling Symptom Assessment Scale (G-SAS)
Hide Description The G-SAS is a 12-item self-rated scale designed to assess gambling symptom severity and change during treatment. Each item on the 12-item scale has a score ranging from 0 – 4. All items ask for an average symptom based on the past 7 days. Total score ranges from 0 – 48: extreme = 41 – 48, severe = 31 – 40, moderate = 21 – 30, mild = 8 – 20.
Time Frame Weekly/bi-weekly visits
Hide Outcome Measure Data
Hide Analysis Population Description
Enrollment was lower than expected and due to the low numbers of subjects completing the study (8 subjects completed all interventions) the numbers were not powerful enough to conduct a full analysis or provide any meaningful statistical analyses.
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description:
Naltrexone: Targeted dosage of 50mg PO daily
Placebo
Overall Number of Participants Analyzed 5 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 5 participants 4 participants
26.8  (11.73) 24.75  (11.53)
End of Study Number Analyzed 5 participants 2 participants
12.6  (9.45) 1.0  (1.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naltrexone, Placebo
Comments Enrollment was lower than expected and due to the low numbers of subjects completing the study (7 subjects (5 active and 2 placebo) completed all interventions) the numbers were not powerful enough to conduct a full analysis or provide any meaningful statistical analyses. We are including the mean and SD of each arm at the beginning and end of the study only as a comparison and not as a meaningful analysis.
Type of Statistical Test Other
Comments We are including the mean and SD of each arm at the start and end of study only as a comparison and not a meaningful analysis. Since higher scores represent a more severe form of the disorder, a drop in scores is seen as an indicator that the treatment had an effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 14.2
Parameter Dispersion
Type: Standard Deviation
Value: 9.45
Estimation Comments The active treatment arm had a mean G-SAS score of 26.8 (n=5) at study start with a SD of 11.73. At end the active treatment arm had a mean G-SAS score of 12.6 (n=5) with a SD of 9.45. The placebo arm is not included as there were only 2 scores.
Time Frame 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description Naltrexone: Targeted dosage of 50mg PO daily Placebo
All-Cause Mortality
Naltrexone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/4 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Naltrexone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Naltrexone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/4 (0.00%) 
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.
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
Layout table for Results Point of Contact information
Name/Title: Dr. Marc N Potenza
Organization: Yale University
Phone: 2037373553
EMail: marc.potenza@yale.edu
Publications:
Layout table for additonal information
Responsible Party: 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: October 13, 2017