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This study was terminated for reasons not related to efficacy or safety
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This study will measure the amount of buprenorphine found in the blood after taking sublingual buprenorphine tablets versus after implantation with 4 Probuphine (buprenorphine implants).
This is an open-label study intended to evaluate the relative bioavailability of 4 Probuphine implants versus 16mg QD sublingual buprenorphine, as determined by plasma BPN AUC(0-24), during 24 hours at steady state. This study will also provide open-label safety and tolerability data in patients treated with Probuphine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probuphine | Experimental | Patients are first inducted on SL BPN, and then switched to 4 Probuphine implants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probuphine (buprenorphine implant) | Drug | Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug. (4 implants) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma BPN AUC(0-24)during 24 hours at steady state. | Day -1, Day -2 and Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma BPN and NorBPN Cmax | week 4 | |
| Time to maximum plasma BPN and NorBPN concentration (tmax) | Day -2, Day -1 and Day 1 | |
| Plasma BPN and NorBPN AUC(0-24) during 24 hours at steady state |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Segal Institute For Clinical Research | Fort Lauderdale | Florida | 33308 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Sublingual Buprenorphine | Drug | 16 mg/day, QD |
|
| week 4 |
| Change in plasma BPN concentration | 24 weeks |
| Number of subjects with adverse events as a measure of safety and tolerability | Adverse events that occurred after the signing of informed consent until 14 days after study drug treatment has been discontinued, or AEs designated as possibly-related to study drug and Serious AEs until resolution or stabilization, were followed. | approx. 11 weeks (due to study termination) |
| 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 |