Emergency Department-Initiated Buprenorphine Validation Network Trial
NCT ID: NCT04225598
Last Updated: 2025-01-10
Study Results
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Basic Information
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COMPLETED
PHASE2
2000 participants
INTERVENTIONAL
2020-07-08
2024-12-06
Brief Summary
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Detailed Description
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1. Site implementation component:
In this component, the investigators will use previously developed implementation facilitation strategies and resources to train ED providers and staff at approximately 30 diverse EDs in treatment initiation with SL-BUP and XR-BUP and develop ED buprenorphine protocols and procedures. The investigators anticipate that this will result in a minimum of 24 sites (80%) that will meet the implementation milestones for competence in ED-initiated BUP using standard SL and XR-BUP inductions.
2. Effectiveness RCT component:
This component is a large pragmatic RCT using a Hybrid Type 1 Effectiveness-Implementation design. Sites that satisfactorily complete the site implementation component will be activated on a rolling basis for the RCT after demonstrated implementation milestones have been met. In this Hybrid Type 1 design the primary research question is the effectiveness of SL-BUP induction compared with that of XR-BUP on the primary outcome measure of engagement in formal addiction treatment at 7-days post ED visit. This design also allows us to gather information and report on implementation processes.
3. Ancillary component - XR-BUP Induction for patients with COWS \< 8:
This observational case series will begin in advance of the Effectiveness RCT component at approximately 4 ED sites with extensive experience in ED-initiated BUP. The investigators will collect quantitative and qualitative data on the use of XR-BUP in ED patients with low COWS scores for approximately 75 patients. Sites will receive a supply of XR-BUP for provision to up to 5 patients with a COWS score \> 8. The purpose is to pre-study the procedures at the four ancillary study sites on treating OUD patients with XR-BUP prior to initiation of the ancillary component. Data collected from this pre-study will not be included in the analysis of the ancillary and effectiveness RCT component. These initial up to 20 pre-study patients will meet all other study criteria and undergo all assessments. It is anticipated that the information collected from the 75 patients in the ancillary component will allow for modification to the larger Effectiveness RCT by expanding eligibility criteria to include patients with COWS \<8.
4. Development and validation of EHR ED opioid-related phenotypes component:
In this component, the investigators will develop EHR phenotypes of opioid-related illnesses that accurately and automatically characterize patient conditions, enhance the ability to actively monitor and surveil, and better identify representative samples and patients potentially eligible for study inclusion, leading ultimately to an enhanced inclusion and understanding of opioid-related conditions. At the primary Yale New Haven Health System sites, the phenotypes (rules- and machine learning-based) will be iteratively developed and internally validated. The rules-based phenotype will be mapped to a common data model and externally validated at 4 trial sites.
5. An exploratory outcome of this study will be to assess the impact of COVID-19 on ED use for opioid-related diagnoses using EHR data.
The primary focus of this clinicaltrials.gov registration are the RCT outcomes. Implementation and ancillary outcomes will be identified as secondary outcomes for the purpose of this clinicaltrials.gov registration
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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XR-BUP
Injectable buprenorphine
CAM2038
Patients will receive a 24 mg dose of injectable CAM2038 in the ED on Day 0.
Standard SL-BUP
Sublingual buprenorphine
Buprenorphine Sublingual Product
COWS ≥ 8: Patients will receive 4mg of SL-BUP for a COWS score of 8-12 (mild withdrawal). After 30-45 minutes if tolerated and no unanticipated adverse reactions, an additional 4mg can be administered for a total of 8mg in the ED. Patients presenting with moderate-severe withdrawal (COWS \>≥ 13) will receive an initial dose of 8mg SL-BUP. All patients will receive a buprenorphine prescription and instructions for additional BUP doses to allow for up to a dose of 12mg if needed, and for 16mg each subsequent day until their scheduled follow up appointment for ongoing MOUD (medications for opioid use disorder).
COWS 4-7: Patients will be provided with a uniform set of instructions to guide unobserved (home) induction. They will be prescribed doses of SL-BUP to allow them to take dose up to 12mg in the 24 hours after discharge. All patients will also receive a buprenorphine prescription for 16mg each subsequent day until their scheduled follow up appointment for ongoing MOUD.
Interventions
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CAM2038
Patients will receive a 24 mg dose of injectable CAM2038 in the ED on Day 0.
Buprenorphine Sublingual Product
COWS ≥ 8: Patients will receive 4mg of SL-BUP for a COWS score of 8-12 (mild withdrawal). After 30-45 minutes if tolerated and no unanticipated adverse reactions, an additional 4mg can be administered for a total of 8mg in the ED. Patients presenting with moderate-severe withdrawal (COWS \>≥ 13) will receive an initial dose of 8mg SL-BUP. All patients will receive a buprenorphine prescription and instructions for additional BUP doses to allow for up to a dose of 12mg if needed, and for 16mg each subsequent day until their scheduled follow up appointment for ongoing MOUD (medications for opioid use disorder).
COWS 4-7: Patients will be provided with a uniform set of instructions to guide unobserved (home) induction. They will be prescribed doses of SL-BUP to allow them to take dose up to 12mg in the 24 hours after discharge. All patients will also receive a buprenorphine prescription for 16mg each subsequent day until their scheduled follow up appointment for ongoing MOUD.
Eligibility Criteria
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Inclusion Criteria
2. Treated in the ED during study screening hours
3. Meet DSM-5 (Diagnostic and Statistical Manual) diagnostic criteria for moderate to severe OUD
4. Have a COWS score of \> or equal to 4
5. Have a urine toxicology test that is positive for opioids (opiates, oxycodone, buprenorphine). Patients with urines that are only positive for fentanyl will be eligible if their clinical history and physical exam are consistent with opioid use and they meet DSM-5 criteria for moderate to severe OUD.
6. Able to speak English sufficiently to understand the study the study procedures and provide written informed consent to participate in the study. (Exception may be made if sites with large population of Spanish speaking patients are accepted for participation in the study and study materials are translated into Spanish. Translated study materials will be reviewed and approved by the Institutional Review Board) IRB of record prior to use.)
1. Be 18 years or older
2. Treated in the ED during study screening hours
3. Meet DSM-5 diagnostic criteria for moderate to severe opioid use disorder
4. Have a COWS \<8
5. Have a urine toxicology test that is positive for opioids (opiates, oxycodone, or buprenorphine). Patients with urines that are only positive for fentanyl on the point of care test strip will be eligible if their clinical history and physical exam are consistent with opioid use and they meet DSM-5 criteria for moderate to severe OUD.
6. Be able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study
Exclusion Criteria
2. Be pregnant as determined by human chorionic gonadotropin (hCG) testing at the index ED visit
3. Have a medical or psychiatric condition that requires hospitalization
4. Opioid administration (excluding BUP) at the index ED visit, prior to enrollment, and COWS remains \< 8 during ED stay
5. Be actively suicidal or severely cognitively impaired precluding informed consent
6. Present from an extended care facility (e.g., skilled nursing facility)
7. Require continued prescription opioids for a pain condition
8. Be a prisoner or in police custody at the time of index ED visit
9. Be currently (anytime within the past 14 days) enrolled in formal addiction treatment, including by court order. Patients enrolled in formal addiction who are not receiving MOUD are eligible
10. Be unable to provide reliable locator information including 2 contact numbers in addition to their own
11. Be unwilling to follow study procedures (e.g., unwilling to provide permission to contact referral provider/program or unavailable for the follow-up assessments)
12. Have prior enrollment in the current study component
Ancillary Component:
1. Have a urine toxicology test that is positive for methadone
2. Be pregnant as determined by human chorionic gonadotropin (hCG) testing at the index ED visit
3. Have a medical or psychiatric condition that requires hospitalization at the index ED visit, prior to enrollment
4. Be actively suicidal or severely cognitively impaired precluding informed consent
5. Present from an extended care facility (e.g., skilled nursing facility)
6. Require continued prescription opioids for a pain condition
7. Be a prisoner or in police custody at the time of index ED visit
8. Be currently (anytime within the past 7 days) enrolled in formal addiction treatment, including by court order. Patients enrolled in formal addiction treatment but are not receiving MOUD are eligible
9. Be unable to provide reliable locator information including 2 contact numbers in addition to their own
10. Be unwilling to follow study procedures (e.g., unwilling to provide permission to answer daily assessments until day 7)
11. Have prior enrollment in the current study
18 Years
ALL
No
Sponsors
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National Drug Abuse Treatment Clinical Trials Network
NETWORK
The Emmes Company, LLC
INDUSTRY
Harvard Medical School (HMS and HSDM)
OTHER
University of Pennsylvania
OTHER
NYU Langone Health
OTHER
Icahn School of Medicine at Mount Sinai
OTHER
Alameda Health System
OTHER
Weill Medical College of Cornell University
OTHER
National Institute on Drug Abuse (NIDA)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Gail D'Onofrio, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Yale School of Medicine, Department of Emergency Medicine
David Fiellin, MD
Role: PRINCIPAL_INVESTIGATOR
Yale School of Medicine, Department of Internal Medicine
Locations
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Highland Hospital
Oakland, California, United States
San Leandro Hospital
San Leandro, California, United States
Yale New Haven Health (Yale New Haven Hospital)
New Haven, Connecticut, United States
Jackson Memorial Hospital
Miami, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Chicago Medicine
Chicago, Illinois, United States
Maine Medical Center
Portland, Maine, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Detroit Receiving Hospital
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Barnes Jewish Hospital
St Louis, Missouri, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Cooper University Hospital
Camden, New Jersey, United States
Presybterian Hospital, Albuquerque, NM
Albuquerque, New Mexico, United States
University of New Mexico Hospital
Albuquerque, New Mexico, United States
Bellevue Hospital
New York, New York, United States
Icahn School of Medicine
New York, New York, United States
Columbia University Irving Medical Center- NY Presbyterian
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Upstate Medical University
Syracuse, New York, United States
Duke University
Durham, North Carolina, United States
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States
Pennsylvania Presbyterian Medical Center/Hospital of UPENN
Philadelphia, Pennsylvania, United States
Temple University Hospital - Episcopal Campus
Philadelphia, Pennsylvania, United States
UPMC Mercy Hospital
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital/The Miriam Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Parkland Memorial Hospital
Dallas, Texas, United States
University of Utah Hospital
Salt Lake City, Utah, United States
University of Washington Medical Center- Harborview/Montlake
Seattle, Washington, United States
West Virginia University - Berkeley Medical Center
Martinsburg, West Virginia, United States
Countries
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References
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D'Onofrio G, Herring AA, Perrone J, Hawk K, Samuels EA, Cowan E, Anderson E, McCormack R, Huntley K, Owens P, Martel S, Schactman M, Lofwall MR, Walsh SL, Dziura J, Fiellin DA. Extended-Release 7-Day Injectable Buprenorphine for Patients With Minimal to Mild Opioid Withdrawal. JAMA Netw Open. 2024 Jul 1;7(7):e2420702. doi: 10.1001/jamanetworkopen.2024.20702.
Snavely AC, Paradee BE, Ashburn NP, Allen BR, Christenson R, O'Neill JC, Nowak R, Wilkerson RG, Mumma BE, Madsen T, Stopyra JP, Mahler SA. Derivation and validation of a high sensitivity troponin-T HEART pathway. Am Heart J. 2023 Feb;256:148-157. doi: 10.1016/j.ahj.2022.11.012. Epub 2022 Nov 16.
Other Identifiers
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2000026164
Identifier Type: -
Identifier Source: org_study_id
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