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continuing study was no longer feasible
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| Name | Class |
|---|---|
| Alkermes, Inc. | INDUSTRY |
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A short-term treatment with buprenorphine prior to initiating treatment with naltrexone may increase the proportion of heroin-dependent patients successfully inducted onto Vivitrol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short-term treatment with buprenorphine | Experimental | Short-term treatment with buprenorphine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine/naloxone | Drug | 3 week treatment with buprenorphine/naloxone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Heroin-dependent Patients Successfully Inducted Onto Vivitrol | Number of patients who received the first Vivitrol injection among those who initiated the induction | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Short-term Treatment With Buprenorphine | Short-term treatment with buprenorphine Buprenorphine/naloxone: 3 week treatment with buprenorphine/naloxone followed by initiation of XR-naltrexone |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants who consented to and initiated study
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| ID | Title | Description |
|---|---|---|
| BG000 | Short-term Treatment With Buprenorphine | Short-term treatment with buprenorphine Buprenorphine/naloxone: 3 week treatment with buprenorphine/naloxone followed by initiation of XR-naltrexone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Proportion of Heroin-dependent Patients Successfully Inducted Onto Vivitrol | Number of patients who received the first Vivitrol injection among those who initiated the induction | Posted | Count of Participants | Participants | 12 weeks |
|
|
12 weeks of treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Short-term Treatment With Buprenorphine | Short-term treatment with buprenorphine Buprenorphine/naloxone: 3 week treatment with buprenorphine/naloxone followed by initiation of treatment with Vivitrol |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| depressive symptoms | Psychiatric disorders | Systematic Assessment | patient reported worsening of depressed mood during buprenorphine taper |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Adam Bisaga, study PI | NYS Psychiatric Institute | 646-774-6155 | adam.bisaga@nyspi.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Oct 10, 2018 | Oct 28, 2022 | Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 17, 2017 | Oct 28, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006556 | Heroin Dependence |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D000069479 | Buprenorphine, Naloxone Drug Combination |
| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 1 |
| 8 |
|
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| D001523 | Mental Disorders |
| D006571 |
| Heterocyclic Compounds |
| D009270 | Naloxone |
| 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 |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |