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Drug Treatment for Pathologic Gambling Disorder

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ClinicalTrials.gov Identifier: NCT00053677
Recruitment Status : Completed
First Posted : February 5, 2003
Results First Posted : October 3, 2017
Last Update Posted : October 3, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Jon Grant, University of Chicago

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
Enrollment 83
Recruitment Details  
Pre-assignment Details 83 participants began the placebo lead-in phase. 6 of those were placebo responders. The remaining 77 were randomized to Naltrexone or placebo.
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description

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.

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

Placebo: For subjects who were randomly assigned to placebo.

Period Title: Overall Study
Started 58 19
Completed 36 13
Not Completed 22 6
Arm/Group Title Naltrexone Placebo Total
Hide Arm/Group Description

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.

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

Placebo: For subjects who were randomly assigned to placebo.

Total of all reporting groups
Overall Number of Baseline Participants 58 19 77
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 58 participants 19 participants 77 participants
47.8  (9.65) 44.7  (9.67) 46.3  (9.66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 19 participants 77 participants
Female 37 10 47
Male 21 9 30
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Number Analyzed 58 participants 19 participants 77 participants
White 54 16 70
Other Race 4 3 7
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 58 participants 19 participants 77 participants
58 19 77
1.Primary Outcome
Title Yale-Brown Obsessive Compulsive Scale for Pathological Gambling (PG-YBOCS)
Hide Description A gambling severity measure derived from the Yale-Brown Obsessive Compulsive Scale. It sums gambling urges and thoughts questions to make a total score. Total scores range from 0 to 40, which higher scores indicating more severe gambling symptoms (worse outcome).Administered every week for the first 8 weeks and every other week for the remaining 10 weeks. Final visit scores were the scores measured at the last visit for each participant; data from previous visits were not combined to compute this value.
Time Frame 18 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description:

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.

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

Placebo: For subjects who were randomly assigned to placebo.

Overall Number of Participants Analyzed 58 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 16.9  (6.60) 18.6  (4.90)
Final Visit Score 9.7  (8.12) 12.9  (9.31)
Time Frame Adverse event data were collected for the duration of the study (18 weeks per subject).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description

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.

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

Placebo: For subjects who were randomly assigned to placebo.

All-Cause Mortality
Naltrexone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Naltrexone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/58 (0.00%)   0/19 (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   50/58 (86.21%)   17/19 (89.47%) 
Gastrointestinal disorders     
Nausea *  35/58 (60.34%)  7/19 (36.84%) 
Diarrhea *  8/58 (13.79%)  6/19 (31.58%) 
Constipation *  3/58 (5.17%)  3/19 (15.79%) 
General disorders     
Dry Mouth *  8/58 (13.79%)  2/19 (10.53%) 
Dizziness *  6/58 (10.34%)  1/19 (5.26%) 
Nervous system disorders     
Headache *  23/58 (39.66%)  9/19 (47.37%) 
Insomnia *  7/58 (12.07%)  0/19 (0.00%) 
*
Indicates events were collected by non-systematic assessment
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.
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
Responsible Party: Jon Grant, University of Chicago
ClinicalTrials.gov Identifier: NCT00053677     History of Changes
Other Study ID Numbers: R21MH065920 ( U.S. NIH Grant/Contract )
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