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| ID | Type | Description | Link |
|---|---|---|---|
| 3UG1DA015831-24S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Drug Abuse Treatment Clinical Trials Network | NETWORK |
| The Emmes Company, LLC | INDUSTRY |
| National Institute on Drug Abuse (NIDA) | NIH |
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This is a multisite EMS study that will first conduct a sequence of pragmatic, prehospital field studies to provide preliminary feasibility, acceptability, and safety data for refinement and enhancement of a subsequent single-arm prospective trial that will provide preliminary effectiveness data, from which to build a larger randomized control trail (RCT) trial.
Evaluating the EMS clinical protocol details and subsequent research procedures will be accomplished by enrolling approximately five EMS-initiated BUP encounters per site. Subsequently, a pragmatic field study will engage approximately thirty successful BUP initiations to assess the feasibility, acceptability, and safety of the EMS clinical protocol and follow up procedures. Investigators will also enroll a cohort of up to thirty patients per site who are eligible for BUP but refuse for informative purposes only, to understand reasons for refusal. Qualitative data on the refusal cohort will be analyzed separately. The outcomes of the pragmatic studies will inform revisions to the EMS clinical protocol.
A single-arm prospective trial of approximately 100 patients per site will subsequently be conducted to collect preliminary data on the effectiveness of EMS-initiated BUP on engagement in MOUD treatment within 10 and 30 days after the EMS-initiated BUP encounter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants | Individuals with opioid use disorder (OUD) who encounter Emergency Medical Services (EMS) in the prehospital setting under one of two circumstances: (1) They have experienced an overdose requiring naloxone reversal or (2) They are in acute opioid abstinence withdrawal and are offered an EMS-initiated BUP clinical protocol. |
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| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome Measure for Pragmatic Field Study | Feasibility and acceptability will be measured by the proportion of patients who accept EMS-initiated BUP among all patients who are offered the EMS-initiated BUP clinical protocol. | Baseline |
| Primary Outcome Measure for the Single Arm Prospective Trial | The proportion of participants engaged in MOUD within 10 days post EMS-initiated BUP among participants who received BUP and consented to be followed | Within 10 days after EMS encounter |
| Measure | Description | Time Frame |
|---|---|---|
| Engagement in Treatment (30) | The proportion of patients participating in MOUD treatment | Within 30 days after EMS encounter |
| Precipitated Withdrawal | The proportion of patients who develop precipitated withdrawal among all those who accepted EMS buprenorphine. |
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Inclusion Criteria:
Patients that accept EMS-Initiated BUP protocol. Patients offered the EMS-Initiated BUP protocol but declined.1
Exclusion Criteria:
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Individuals in the prehospital setting with OUD 1) presenting with overdose requiring naloxone reversal or 2) in acute opioid abstinence withdrawal offered an EMS clinical protocol across approximately three ED-EMS systems.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gail D'Onofrio, MD, MS | Contact | 12037857059 | gail.donofrio@yale.edu | |
| Gerard Carroll, MD | Contact | Carroll-Gerard@CooperHealth.edu |
| Name | Affiliation | Role |
|---|---|---|
| Gail D'Onofrio, MD, MS | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alameda Health System | Oakland | California | 94602 | United States |
In line with the National Institutes of Health Helping to End Addiction Long-term (NIH HEAL) Initiative Public Access and Data Sharing Policy, publications and underlying primary data will be made available to the public.
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Data will be made available after 1) The primary outcome paper has been accepted for publication, or 2) the data is locked for more than 18 months, whichever comes first.
De-identified scientific data generated from this study will be made available to the public in the NIDA data repository, per NIDA CTN policy and the Data Management and Sharing Plan for the study.
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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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| Baseline |
| ED Visits and Hospitalizations | Proportion of patients with subsequent ED visits and hospitalizations post EMS BUP among those who accepted EMS buprenorphine | Within 30 days after EMS encounter |
| Adverse Events | The number of adverse events per participant after EMS-BUP initiation among all those who accepted EMS-BUP | Within 30 days after EMS-BUP encounter |
| Hennepin Healthcare | Minneapolis | Minnesota | 55415 | United States |
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| Cooper University Hospital | Camden | New Jersey | 08103 | United States |
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