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
|Condition or disease||Intervention/treatment||Phase|
|Gambling||Drug: Naltrexone Drug: Placebo||Phase 3|
PGD is a prominent and growing social problem. Unfortunately, there is no established drug treatment for this disorder. Preliminary investigations demonstrate that naltrexone in doses up to 250 mg/day is well tolerated and safe during an 11-week period and may be a viable treatment option for PGD patients with severe urges. The implications of this study extend from PGD to other impulse control disorders, including compulsive shopping, kleptomania, and possibly alcoholism.
Participants are randomly assigned to receive either naltrexone or placebo for 16 weeks. The responses of men and women are compared to determine whether efficacy is distributed in a male:female ratio analogous to that of the PGD population in the United States. A Clinical Global Impression and a Gambling Symptom Scale are used to assess participants.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||83 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Naltrexone Treatment in Pathologic Gambling Disorder|
|Study Start Date :||December 2002|
|Actual Primary Completion Date :||November 2005|
|Actual Study Completion Date :||November 2005|
Placebo Comparator: 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.
For subjects who were randomly assigned to naltrexone 50mg/day, 100mg/day, or 150mg/day.
Placebo Comparator: Placebo
Subjects who were assigned to placebo in the 17 week double-blind phase.
For subjects who were randomly assigned to placebo.
- Yale-Brown Obsessive Compulsive Scale for Pathological Gambling (PG-YBOCS) [ Time Frame: 18 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00053677
|United States, Minnesota|
|University of Minnesota Medical School|
|Minneapolis, Minnesota, United States, 55454|
|Principal Investigator:||Suck Won Kim, M.D.||University of Minnesota - Clinical and Translational Science Institute|