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This study will evaluate the abuse potential of ALKS 5461.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALKS 5461 Dose 1 | Experimental | Sublingual tablets |
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| ALKS 5461 Dose 2 | Experimental | Sublingual tablets |
|
| ALKS 5461 Dose 3 | Experimental | Sublingual tablets |
|
| Buprenorphine Dose 1 | Active Comparator | Sublingual tablets |
|
| Buprenorphine Dose 2 | Active Comparator | Sublingual tablets |
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| Placebo | Placebo Comparator | Sublingual tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALKS 5461 | Drug | Sublingual tablets, single administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics: Abuse potential measured by visual analog scales (VAS) | Approximately 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events (AEs) | Up to 14 weeks | |
| Pharmacokinetics: Plasma concentrations of ALKS 5461 | Up to 14 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sanjeev Pathak, MD | Alkermes, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alkermes Investigational Site | Overland Park | Kansas | 66212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30102427 | Derived | Pathak S, Vince B, Kelsh D, Shram MJ, Setnik B, Lu H, Nangia N, Stanford AD, Ehrich E. Abuse Potential of Buprenorphine/Samidorphan Combination Compared to Buprenorphine and Placebo: A Phase 1 Randomized Controlled Trial. J Clin Pharmacol. 2019 Feb;59(2):206-217. doi: 10.1002/jcph.1280. Epub 2018 Aug 13. |
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| ID | Term |
|---|---|
| C000618349 | ALKS 5461 |
| D002047 | Buprenorphine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Buprenorphine | Drug | Sublingual tablets, single administration |
|
| Placebo | Drug | Sublingual tablets, single administration |
|
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |