Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The determine the effect of cyclosporine on buprenorphine disposition
Subjects studied on four occasions:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Arm | Experimental | Subjects will be studied on four occasions. Sessions and drugs are:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| buprenorphine | Drug | Session 1 Intravenous buprenorphine: 0.2 mg over 1 hr Session 2 Sublingual buprenorphine: 2 mg Session 3 Intravenous buprenorphine 0.2 mg over 1 hr beginning 1 hr after starting cyclosporine Session 4 Sublingual buprenorphine: 2 mg after cyclosporine. |
| Measure | Description | Time Frame |
|---|---|---|
| Buprenorphine Plasma Cmax | 96 hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Evan Kharasch, MD, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63012 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Buprenorphine | Subjects will be studied on four occasions. Sessions and drugs are:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intravenous Buprenorphine |
|
| ||||||||||||||||||
| Sublingual Buprenorphine |
| |||||||||||||||||||
| Cyclosporine Plus IV Buprenorphine |
| |||||||||||||||||||
| Cyclosporine + Sublingual Buprenorphine |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Study Arm | Subjects will be studied on four occasions. Sessions and drugs are:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Buprenorphine Plasma Cmax | 0 Participants Analyzed. The PI has left the institution. Sincere efforts were made to contact the PI but were unsuccessful. No study data are available. | Posted | 96 hours |
|
Up to 12 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intravenous Buprenorphine | Intravenous buprenorphine: 0.2 mg infused over 1 hr |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Evan Kharasch MD PhD | Washington University | 3143628796 | kharasch@wustl.edu |
Not provided
| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG003 | Cyclosporine + Sublingual Buprenorphine | Sublingual buprenorphine: 2 mg; continue oral cyclosporine 4.5 mg/kg twice daily for 5 days |
|
| 0 |
| 18 |
| 0 |
| 18 |
| 16 |
| 18 |
| EG001 | Sublingual Buprenorphine | Sublingual buprenorphine: 2 mg | 0 | 18 | 0 | 18 | 17 | 18 |
| EG002 | Cyclosporine Plus Intravenous Buprenorphine | Cyclosporine (2.5mg/kg/hr infused over 2 hr), then intravenous buprenor-phine 0.2 mg infused over 1 hr beginning 1 hr after starting cyclosporine. Subjects then take oral cyclosporine 4.5 mg/kg twice daily | 0 | 18 | 0 | 18 | 17 | 18 |
| EG003 | Cyclosporine Plus Sublingual Buprenorphine | Sublingual buprenorphine: 2 mg; continue oral cyclosporine 4.5 mg/kg twice daily for 5 days | 0 | 18 | 0 | 18 | 18 | 18 |
| itch | General disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Dizzyness | Nervous system disorders | Systematic Assessment |
|
| Other | Product Issues | Systematic Assessment |
|
Not provided
Not provided
Not provided
| 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 |