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The purpose of this study is to determine if nalmefene is safe and effective in the treatment of pathological gambling.
Randomized, double-blind, placebo-controlled, parallel-group, multi-centered, outpatient study to assess the efficacy, safety and tolerability of two doses of nalmefene in patients with current diagnosis of pathological gambling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Nalmefene HCl 20 mg |
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| 2 | Experimental | Nalmefene HCl 40 mg |
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| 3 | Placebo Comparator | Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nalmefene HCl | Drug | Nalmefene HCl film-coated tablets, 20 or 40 mg, administered orally once daily for 10 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Assess efficacy in treatment of pathological gambling |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate safety and tolerability in treatment of pathological gambling |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Jochelson, MD | Somaxon Pharmaceuticals CMO | Study Director |
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| ID | Term |
|---|---|
| D005715 | Gambling |
| ID | Term |
|---|---|
| D012309 | Risk-Taking |
| D001519 | Behavior |
| D007174 | Disruptive, Impulse Control, and Conduct Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C038981 | nalmefene |
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| Placebo | Other | Placebo tablet |
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