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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21DA049859-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Substance Abuse and Mental Health Services Administration (SAMHSA) | FED |
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this study is 1) to evaluate whether emergency department-initiated medically assisted treatment with Buprenorphine/Naloxone in patients presenting with opioid use disorder will produce positive outcomes at 1 week, 3 months and 6 months after treatment initiation.
The emergency department is a critical missed opportunity to engage patients with opioid use disorder in medication-assisted treatment, the most effective current treatment for the disorder. Patients presenting at the emergency department with opioid use disorder will be given the opportunity to immediately start medication assisted treatment with Naloxone/Buprenorphine then referred either to a specialized addiction bridge clinic or a local waivered provider for further treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bridge Clinic | Experimental | Medication assisted treatment supervised by addiction bridge clinic until stabilized in treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bridge Clinic | Other | Specialized addiction bridge clinic |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Self-reported Treatment Retention | Self-reported enrollment in treatment for opioid use disorder after 1 week | 1 week |
| Number of Participants With Self-reported Treatment Retention | Self-reported enrollment in treatment for opioid use disorder after 3 months | 3 months |
| Number of Participants With Self-reported Treatment Retention | Self-reported enrollment in treatment for opioid use disorder after 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Illicit Opioid Use | Urine analyzed for opioids (buprenorphine, methadone, oxycodone, hydrocodone, hydromorphone, heroin, fentanyl) and other drugs (cocaine, amphetamines, benzodiazepines, cannabinoids) via enzyme multiplied immunoassay. Note buprenorphine and methadone positive results not treated as illicit. | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Vermont Medical Center | Burlington | Vermont | 05401 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bridge Clinic | Medication assisted treatment supervised by addiction bridge clinic until stabilized in treatment. Bridge Clinic: Specialized addiction bridge clinic |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| 1 Week Eligible to Self-report |
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| 1 Week Contacted for Self-report |
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| 1 Week Eligible for Urinanalysis |
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| 1 Week Urine Sample Provided |
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| 3 Months Eligible to Self-report |
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| 3 Months Contacted for Self-report |
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| 3 Months Eligible for Urinanalysis |
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| 3 Months Urine Sample Provided |
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| 6 Months Eligible to Self-report |
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| 6 Months Contacted for Self-report |
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| 6 Months Eligible for Urinanalysis |
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| 6 Months Urine Sample Provided |
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94 participants were available for analysis after 10 were withdrawn from the study
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| ID | Title | Description |
|---|---|---|
| BG000 | Bridge Clinic | Medication assisted treatment supervised by addiction bridge clinic until stabilized in treatment. Bridge Clinic: Specialized addiction bridge clinic |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Number of Participants With Self-reported Treatment Retention | Self-reported enrollment in treatment for opioid use disorder after 1 week | Posted | Count of Participants | Participants | 1 week |
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6 months
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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 | Bridge Clinic | Medication assisted treatment supervised by addiction bridge clinic until stabilized in treatment. Bridge Clinic: Specialized addiction bridge clinic |
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Urinalysis was disrupted by the COVID-19 epidemic. Consequently, urinalysis at 1 week, 3 months, and 6 months (although reported) should be regarded with caution.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Scott Mackey, PhD | University of Vermont | 8028478767 | msmackey@uvm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 7, 2021 | Nov 1, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| Number of Participants With Illicit Opioid Use | Urine analyzed for opioids (buprenorphine, methadone, oxycodone, hydrocodone, hydromorphone, heroin, fentanyl) and other drugs (cocaine, amphetamines, benzodiazepines, cannabinoids) via enzyme multiplied immunoassay. Note buprenorphine and methadone positive results not treated as illicit. | 3 months |
| Number of Participants With Illicit Opioid Use | Urine analyzed for opioids (buprenorphine, methadone, oxycodone, hydrocodone, hydromorphone, heroin, fentanyl) and other drugs (cocaine, amphetamines, benzodiazepines, cannabinoids) via enzyme multiplied immunoassay. Note buprenorphine and methadone positive results not treated as illicit. | 6 months |
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| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Number of Participants With Self-reported Treatment Retention | Self-reported enrollment in treatment for opioid use disorder after 3 months | Posted | Count of Participants | Participants | 3 months |
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| Primary | Number of Participants With Self-reported Treatment Retention | Self-reported enrollment in treatment for opioid use disorder after 6 months | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Number of Participants With Illicit Opioid Use | Urine analyzed for opioids (buprenorphine, methadone, oxycodone, hydrocodone, hydromorphone, heroin, fentanyl) and other drugs (cocaine, amphetamines, benzodiazepines, cannabinoids) via enzyme multiplied immunoassay. Note buprenorphine and methadone positive results not treated as illicit. | Posted | Count of Participants | Participants | 1 week |
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| Secondary | Number of Participants With Illicit Opioid Use | Urine analyzed for opioids (buprenorphine, methadone, oxycodone, hydrocodone, hydromorphone, heroin, fentanyl) and other drugs (cocaine, amphetamines, benzodiazepines, cannabinoids) via enzyme multiplied immunoassay. Note buprenorphine and methadone positive results not treated as illicit. | Posted | Count of Participants | Participants | 3 months |
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|
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| Secondary | Number of Participants With Illicit Opioid Use | Urine analyzed for opioids (buprenorphine, methadone, oxycodone, hydrocodone, hydromorphone, heroin, fentanyl) and other drugs (cocaine, amphetamines, benzodiazepines, cannabinoids) via enzyme multiplied immunoassay. Note buprenorphine and methadone positive results not treated as illicit. | Posted | Count of Participants | Participants | 6 months |
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| 0 |
| 94 |
| 0 |
| 94 |
| 0 |
| 94 |
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