|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
National Institute of Mental Health (NIMH) |
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00053677 |
Purpose
This study will establish the best dose of the drug naltrexone to treat patients with Pathological Gambling Disorder (PGD) and severe urge symptoms.
| Condition | Intervention | Phase |
|
Gambling |
Drug: Naltrexone |
Phase III |
| MedlinePlus related topics: | Compulsive Gambling |
| ChemIDplus related topics: | Naltrexone Naltrexone hydrochloride |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Naltrexone Treatment in Pathologic Gambling Disorder |
| Estimated Enrollment: | 156 |
| Study Start Date: | December 2002 |
| Study Completion Date: | November 2005 |
| Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
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.
Eligibility
| Ages Eligible for Study: | 21 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Contacts and Locations| United States, Minnesota | |||||
| University of Minnesota Medical School | |||||
| Minneapolis, Minnesota, United States, 55454 | |||||
| Principal Investigator: | Suck Won Kim, M.D. | University of Minnesota |
More Information
Related Info 
  |
| Study ID Numbers: | R21 MH65920, DSIR AT-AS |
| First Received: | February 4, 2003 |
| Last Updated: | August 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00053677 |
| Health Authority: | United States: Food and Drug Administration |
|
|
|
|