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To determine if nalmefene is safe and effective in smoking cessation.
Single centered, randomized, placebo-controlled,double-blind, outpatient pilot study to evaluate the efficacy, safety and tolerability of 2 doses of nalmefene on smoking cessation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Nalmefene 40 mg |
|
| 2 | Experimental | Nalmefene 80 mg |
|
| 3 | Other | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nalmefene | Drug | Nalmefene HCl film-coated tablets administered orally, twice daily, for total daily dosage of 40 or 80 mg, for 5 weeks (following a 2-week titration period). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the efficacy of 2 doses of nalmefene relative to placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety and tolerability of 2 doses of nalmefene |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Philip Jochelson, MD | Somaxon Pharmaceuticals CMO | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C038981 | nalmefene |
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| Placebo | Other | Placebo tablets, administered orally, twice daily for 5 weeks (following a 2-week titration period). |
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