Back to resultsEmergency Department-Initiated Buprenorphine Validation Network Trial
Primary Purpose
Opioid-use Disorder
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CAM2038
Buprenorphine Sublingual Product
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-use Disorder focused on measuring Opioid-use Disorder
Eligibility Criteria
RCT Component:
Inclusion Criteria:
- Be 18 years or older
- Treated in the ED during study screening hours
- Meet DSM-5 (Diagnostic and Statistical Manual) diagnostic criteria for moderate to severe OUD
- Have a COWS score of > or equal to 4
- 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.
- 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.)
Exclusion Criteria:
- Have urine toxicology test that is positive for methadone
- Be pregnant as determined by human chorionic gonadotropin (hCG) testing at the index ED visit
- Have a medical or psychiatric condition that requires hospitalization
- Opioid administration (excluding BUP) at the index ED visit, prior to enrollment, and COWS remains < 8 during ED stay
- Be actively suicidal or severely cognitively impaired precluding informed consent
- Present from an extended care facility (e.g., skilled nursing facility)
- Require continued prescription opioids for a pain condition
- Be a prisoner or in police custody at the time of index ED visit
- 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
- Be unable to provide reliable locator information including 2 contact numbers in addition to their own
- Be unwilling to follow study procedures (e.g., unwilling to provide permission to contact referral provider/program or unavailable for the follow-up assessments)
- Have prior enrollment in the current study component
Ancillary Component:
Inclusion Criteria:
- Be 18 years or older
- Treated in the ED during study screening hours
- Meet DSM-5 diagnostic criteria for moderate to severe opioid use disorder
- Have a COWS <8
- 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.
- Be able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study
Exclusion Criteria:
- Have a urine toxicology test that is positive for methadone
- Be pregnant as determined by human chorionic gonadotropin (hCG) testing at the index ED visit
- Have a medical or psychiatric condition that requires hospitalization at the index ED visit, prior to enrollment
- Be actively suicidal or severely cognitively impaired precluding informed consent
- Present from an extended care facility (e.g., skilled nursing facility)
- Require continued prescription opioids for a pain condition
- Be a prisoner or in police custody at the time of index ED visit
- 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
- Be unable to provide reliable locator information including 2 contact numbers in addition to their own
- Be unwilling to follow study procedures (e.g., unwilling to provide permission to answer daily assessments until day 7)
- Have prior enrollment in the current study
Sites / Locations
- Valleywise Health
- Highland HospitalRecruiting
- San Leandro HospitalRecruiting
- Yale New Haven Health (Yale New Haven Hospital)Recruiting
- Jackson Memorial Hospital
- Tampa General HospitalRecruiting
- Grady Memorial HospitalRecruiting
- Northwestern Memorial Hospital
- University of Chicago Medicine
- Maine Medical CenterRecruiting
- Johns Hopkins Hospital
- Detroit Receiving Hospital
- Henry Ford HospitalRecruiting
- Hennepin County Medical CenterRecruiting
- Barnes Jewish Hospital
- Dartmouth-Hitchcock Medical Center
- Cooper University HospitalRecruiting
- Cooper University HospitalRecruiting
- Presybterian Hospital, Albuquerque, NM
- University of New Mexico HospitalRecruiting
- Bellevue Hospital
- Icahn School of Medicine
- Columbia University Irving Medical Center- NY Presbyterian
- Weill Cornell Medical College
- Upstate Medical University
- Duke University
- Wake Forest School of Medicine
- Pennsylvania Presbyterian Medical Center/Hospital of UPENNRecruiting
- Temple University Hospital - Episcopal Campus
- UPMC Mercy Hospital
- Rhode Island Hospital/The Miriam Hospital
- Medical University of South CarolinaRecruiting
- Vanderbilt University Medical CenterRecruiting
- Parkland Memorial Hospital
- University of Utah HospitalRecruiting
- University of Washington Medical Center- Harborview/MontlakeRecruiting
- West Virginia University - Berkeley Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
XR-BUP
Standard SL-BUP
Arm Description
Injectable buprenorphine
Sublingual buprenorphine
Outcomes
Primary Outcome Measures
RCT Component: Patient engagement (yes/no) in formal addiction treatment at 7 days post randomization
Engagement in formal addiction treatment will be defined as enrollment and receiving formal addiction treatment on the 7th day post randomization, confirmed by contact with the facility and/or treating clinician. Formal addiction treatment will be operationally defined as those treatments consistent with the American Society of Addiction Medicine's levels of care (1-4) and can include a range of clinical settings including office-based providers of BUP or naltrexone, opioid treatment programs (OTPs), intensive outpatient, inpatient, or residential treatments. Patients do not need to be receiving MOUD at 7 days to be considered engaged in formal addiction treatment. Participation in a mutual-help program such as Alcoholics Anonymous (AA) or (Narcotics Anonymous) NA alone will not be considered as engagement in formal addiction treatment. Additional analyses evaluating the effects of patient and site characteristics will also be conducted.
Secondary Outcome Measures
RCT Component: Engagement in MOUD (yes/no) at 7 days post randomization
self-report verified with treatment provider(s)
RCT Component: Patient engagement (yes/no) in formal addiction treatment at 30 days post randomization
Engagement in formal addiction treatment will be defined as enrollment in formal addiction treatment on the 30th day post randomization, confirmed by direct contact with the facility and/or treating clinician. Formal addiction treatment will be operationally defined as those treatments consistent with the American Society of Addiction Medicine's levels of care (1-4) and can include a range of clinical settings including office-based providers of BUP or naltrexone, OTPs, intensive outpatient, inpatient, or residential treatments. Patients do not need to be receiving MOUD on the 30th day post randomization to be considered engaged in formal addiction treatment. Participation in a mutual-help program such as Alcoholics or Narcotics Anonymous alone will not be considered as engagement in formal addiction treatment. Additional analyses evaluating the effects of patient and site characteristics will also be conducted.
RCT Component: Patient Engagement in MOUD (yes/no) at 30 days post randomization
self report verified with treatment provider(s)
RCT Component: Self-reported days of illicit opioid use (past 7 days) at 7 days post randomization
The Timeline Follow-back procedure will be used to elicit the patient participant's self-reported days of use of opioids.
RCT Component: Self-reported days of illicit opioid use (past 7 days) at 30 days post randomization
The Timeline Follow-back procedure will be used to elicit the patient participant's self-reported days of use of opioids.
RCT Component: Craving scores at 7 days post randomization
The investigators will use visual analogue scales (VAS) to assess craving, desire to use opioids and need to use opioids with a scale of 0-100.
RCT Component: Healthcare services utilization (past 30 days) regarding ED visits and hospitalizations at 30 days post randomization
A brief, structured interview regarding health care utilization (inpatient and outpatient) will be used, which collects information on the type and amount of services received. This includes ED visits, hospitalizations, primary medical care visits (excluding those for BUP treatment and self-help sources of support (e.g., NA).
RCT Component: Patient satisfaction with BUP at 7 days post randomization
The investigators will modify the patient satisfaction scale where overall experience is rated from 1 to 5 (1 is completely ineffective and 5 is completely effective) and treatment characteristics are rated 1 to 7 (1 is not important and 7 is extremely important) based on previous published data.
RCT Component: Overdose Events at 30 days post randomization
Assessment of past 30-day overdose events will be completed at 30 days post study enrollment. In addition, Site PIs will search local electronic medical records for fatal and non-fatal overdose events.
Ancillary Component: Proportion of participants that experience a 5 or greater increase in COWS score within 4 hours of of XR-BUP administration
Clinical Opiate Withdrawal Scale (COWS) - the COWS is a validated measure of the severity of opioid withdrawal that consists of 11 subjective and objective items. Scores on the individual items are combined to a single overall score that has been used to determine the SL-BUP induction strategy. COWS scoring, and interpretation is as follows: Score: 5-12 = mild opioid withdrawal; 13-24 = moderate opioid withdrawal; 25-36 = moderately severe opioid withdrawal; more than 36 = severe opioid withdrawal.
Ancillary Component: Proportion of participants that transition to moderate withdrawal (COWS 13-24) within 4 hours of XR-BUP administration
Clinical Opiate Withdrawal Scale (COWS) - the COWS is a validated measure of the severity of opioid withdrawal that consists of 11 subjective and objective items. Scores on the individual items are combined to a single overall score that has been used to determine the SL-BUP induction strategy. COWS scoring, and interpretation is as follows: Score: 5-12 = mild opioid withdrawal; 13-24 = moderate opioid withdrawal; 25-36 = moderately severe opioid withdrawal; more than 36 = severe opioid withdrawal.
Ancillary Component: Proportion of participants that experience clinician determined precipitated withdrawal within 1 hour of XR-BUP administration
Assessment of Proportion of participants that experience clinician determined precipitated withdrawal within 1 hour of XR-BUP administration.
Full Information
NCT ID
NCT04225598
First Posted
December 20, 2019
Last Updated
September 22, 2023
Sponsor
Yale University
Collaborators
National Drug Abuse Treatment Clinical Trials Network, The Emmes Company, LLC, Harvard Medical School (HMS and HSDM), University of Pennsylvania, NYU Langone Health, Icahn School of Medicine at Mount Sinai, Alameda Health System, Weill Medical College of Cornell University, National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT04225598
Brief Title
Emergency Department-Initiated Buprenorphine Validation Network Trial
Official Title
Emergency Department-Initiated Buprenorphine Validation Network Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Drug Abuse Treatment Clinical Trials Network, The Emmes Company, LLC, Harvard Medical School (HMS and HSDM), University of Pennsylvania, NYU Langone Health, Icahn School of Medicine at Mount Sinai, Alameda Health System, Weill Medical College of Cornell University, National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will (1) recruit, train and provide resources to approximately 30 Emergency Department (ED) sites throughout the U.S. using implementation facilitation strategies to provide ED-initiated buprenorphine (BUP) for patients presenting with opioid use disorder (OUD) who are not receiving medications for opioid use disorder (MOUD). Once implementation is adequately achieved, the sites will (2) conduct a randomized controlled trial (RCT) to compare the effectiveness of sublingual buprenorphine (SL-BUP) versus extended-release buprenorphine (XR-BUP) on ED patients' engagement in formal addiction treatment 7-days after their ED visit. In addition, in an ancillary component of the study, the investigators will (3) assess the use of XR-BUP in ED patients with Clinical Opioid Withdrawal Scale (COWS) scores < 8 in a case series to potentially expand the eligibility of patients in the larger RCT to those presenting with little to no opioid withdrawal symptoms. Finally, the investigators will (4) develop and validate ED electronic health record (EHR) opioid-related phenotypes, both of which will inform the main RCT.
Detailed Description
The study will be comprised of four components as outlined below:
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.
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.
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.
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder
Keywords
Opioid-use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
XR-BUP
Arm Type
Experimental
Arm Description
Injectable buprenorphine
Arm Title
Standard SL-BUP
Arm Type
Active Comparator
Arm Description
Sublingual buprenorphine
Intervention Type
Drug
Intervention Name(s)
CAM2038
Intervention Description
Patients will receive a 24 mg dose of injectable CAM2038 in the ED on Day 0.
Intervention Type
Drug
Intervention Name(s)
Buprenorphine Sublingual Product
Intervention Description
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.
Primary Outcome Measure Information:
Title
RCT Component: Patient engagement (yes/no) in formal addiction treatment at 7 days post randomization
Description
Engagement in formal addiction treatment will be defined as enrollment and receiving formal addiction treatment on the 7th day post randomization, confirmed by contact with the facility and/or treating clinician. Formal addiction treatment will be operationally defined as those treatments consistent with the American Society of Addiction Medicine's levels of care (1-4) and can include a range of clinical settings including office-based providers of BUP or naltrexone, opioid treatment programs (OTPs), intensive outpatient, inpatient, or residential treatments. Patients do not need to be receiving MOUD at 7 days to be considered engaged in formal addiction treatment. Participation in a mutual-help program such as Alcoholics Anonymous (AA) or (Narcotics Anonymous) NA alone will not be considered as engagement in formal addiction treatment. Additional analyses evaluating the effects of patient and site characteristics will also be conducted.
Time Frame
7 days post randomization
Secondary Outcome Measure Information:
Title
RCT Component: Engagement in MOUD (yes/no) at 7 days post randomization
Description
self-report verified with treatment provider(s)
Time Frame
7 days post randomization
Title
RCT Component: Patient engagement (yes/no) in formal addiction treatment at 30 days post randomization
Description
Engagement in formal addiction treatment will be defined as enrollment in formal addiction treatment on the 30th day post randomization, confirmed by direct contact with the facility and/or treating clinician. Formal addiction treatment will be operationally defined as those treatments consistent with the American Society of Addiction Medicine's levels of care (1-4) and can include a range of clinical settings including office-based providers of BUP or naltrexone, OTPs, intensive outpatient, inpatient, or residential treatments. Patients do not need to be receiving MOUD on the 30th day post randomization to be considered engaged in formal addiction treatment. Participation in a mutual-help program such as Alcoholics or Narcotics Anonymous alone will not be considered as engagement in formal addiction treatment. Additional analyses evaluating the effects of patient and site characteristics will also be conducted.
Time Frame
30 days post randomization
Title
RCT Component: Patient Engagement in MOUD (yes/no) at 30 days post randomization
Description
self report verified with treatment provider(s)
Time Frame
30 days post randomization
Title
RCT Component: Self-reported days of illicit opioid use (past 7 days) at 7 days post randomization
Description
The Timeline Follow-back procedure will be used to elicit the patient participant's self-reported days of use of opioids.
Time Frame
7 days post randomization
Title
RCT Component: Self-reported days of illicit opioid use (past 7 days) at 30 days post randomization
Description
The Timeline Follow-back procedure will be used to elicit the patient participant's self-reported days of use of opioids.
Time Frame
30 days post randomization
Title
RCT Component: Craving scores at 7 days post randomization
Description
The investigators will use visual analogue scales (VAS) to assess craving, desire to use opioids and need to use opioids with a scale of 0-100.
Time Frame
7 days post randomization
Title
RCT Component: Healthcare services utilization (past 30 days) regarding ED visits and hospitalizations at 30 days post randomization
Description
A brief, structured interview regarding health care utilization (inpatient and outpatient) will be used, which collects information on the type and amount of services received. This includes ED visits, hospitalizations, primary medical care visits (excluding those for BUP treatment and self-help sources of support (e.g., NA).
Time Frame
30 days post randomization
Title
RCT Component: Patient satisfaction with BUP at 7 days post randomization
Description
The investigators will modify the patient satisfaction scale where overall experience is rated from 1 to 5 (1 is completely ineffective and 5 is completely effective) and treatment characteristics are rated 1 to 7 (1 is not important and 7 is extremely important) based on previous published data.
Time Frame
7 days post randomization
Title
RCT Component: Overdose Events at 30 days post randomization
Description
Assessment of past 30-day overdose events will be completed at 30 days post study enrollment. In addition, Site PIs will search local electronic medical records for fatal and non-fatal overdose events.
Time Frame
30 days post randomization
Title
Ancillary Component: Proportion of participants that experience a 5 or greater increase in COWS score within 4 hours of of XR-BUP administration
Description
Clinical Opiate Withdrawal Scale (COWS) - the COWS is a validated measure of the severity of opioid withdrawal that consists of 11 subjective and objective items. Scores on the individual items are combined to a single overall score that has been used to determine the SL-BUP induction strategy. COWS scoring, and interpretation is as follows: Score: 5-12 = mild opioid withdrawal; 13-24 = moderate opioid withdrawal; 25-36 = moderately severe opioid withdrawal; more than 36 = severe opioid withdrawal.
Time Frame
Within 4 hours of XR-BUP administration
Title
Ancillary Component: Proportion of participants that transition to moderate withdrawal (COWS 13-24) within 4 hours of XR-BUP administration
Description
Clinical Opiate Withdrawal Scale (COWS) - the COWS is a validated measure of the severity of opioid withdrawal that consists of 11 subjective and objective items. Scores on the individual items are combined to a single overall score that has been used to determine the SL-BUP induction strategy. COWS scoring, and interpretation is as follows: Score: 5-12 = mild opioid withdrawal; 13-24 = moderate opioid withdrawal; 25-36 = moderately severe opioid withdrawal; more than 36 = severe opioid withdrawal.
Time Frame
Within 4 hours of XR-BUP administration
Title
Ancillary Component: Proportion of participants that experience clinician determined precipitated withdrawal within 1 hour of XR-BUP administration
Description
Assessment of Proportion of participants that experience clinician determined precipitated withdrawal within 1 hour of XR-BUP administration.
Time Frame
Within 1 hour post XR-BUP injection
Other Pre-specified Outcome Measures:
Title
RCT Component: Cost effectiveness of XR-BUP compared to SL-BUP using ICER (incremental cost-effectiveness ratio): Engagement
Description
The final outcome measure for the cost-effectiveness analysis is the ICER (incremental cost-effectiveness ratio), which includes the relevant cost differential between the study arms in the numerator, and the difference in a chosen effectiveness measure in the denominator. 3 types of ICERs will be generated, each one with a different effectiveness measure (engagement in formal addiction treatment at 30 days; quality-adjusted life-years (QALYs) gained; and Abstinent Years). The reason being that different ICERs are more relevant to certain potential stakeholder groups than others.
Time Frame
7 days post randomization
Title
RCT Component: Cost effectiveness of XR-BUP compared to SL-BUP using ICER (incremental cost-effectiveness ratio): QALYs
Description
The final outcome measure for the cost-effectiveness analysis is the ICER (incremental cost-effectiveness ratio), which includes the relevant cost differential between the study arms in the numerator, and the difference in a chosen effectiveness measure in the denominator. 3 types of ICERs will be generated, each one with a different effectiveness measure (engagement in formal addiction treatment at 30 days; quality-adjusted life-years (QALYs) gained; and Abstinent Years). The reason being that different ICERs are more relevant to certain potential stakeholder groups than others.
Time Frame
7 days post randomization
Title
RCT Component: Cost effectiveness of XR-BUP compared to SL-BUP using ICER (incremental cost-effectiveness ratio): Abstinent Years
Description
The final outcome measure for the cost-effectiveness analysis is the ICER (incremental cost-effectiveness ratio), which includes the relevant cost differential between the study arms in the numerator, and the difference in a chosen effectiveness measure in the denominator. 3 types of ICERs will be generated, each one with a different effectiveness measure (engagement in formal addiction treatment at 30 days; quality-adjusted life-years (QALYs) gained; and Abstinent Years). The reason being that different ICERs are more relevant to certain potential stakeholder groups than others.
Time Frame
7 days post randomization
Title
RCT Component: Cost effectiveness of XR-BUP compared to SL-BUP using ICER (incremental cost-effectiveness ratio): Engagement
Description
The final outcome measure for the cost-effectiveness analysis is the ICER (incremental cost-effectiveness ratio), which includes the relevant cost differential between the study arms in the numerator, and the difference in a chosen effectiveness measure in the denominator. 3 types of ICERs will be generated, each one with a different effectiveness measure (engagement in formal addiction treatment at 30 days; quality-adjusted life-years (QALYs) gained; and Abstinent Years). The reason being that different ICERs are more relevant to certain potential stakeholder groups than others.
Time Frame
30 days post randomization
Title
RCT Component: Cost effectiveness of XR-BUP compared to SL-BUP using ICER (incremental cost-effectiveness ratio): QALYs
Description
The final outcome measure for the cost-effectiveness analysis is the ICER (incremental cost-effectiveness ratio), which includes the relevant cost differential between the study arms in the numerator, and the difference in a chosen effectiveness measure in the denominator. 3 types of ICERs will be generated, each one with a different effectiveness measure (engagement in formal addiction treatment at 30 days; quality-adjusted life-years (QALYs) gained; and Abstinent Years). The reason being that different ICERs are more relevant to certain potential stakeholder groups than others.
Time Frame
30 days post randomization
Title
RCT Component: Cost effectiveness of XR-BUP compared to SL-BUP using ICER (incremental cost-effectiveness ratio): Abstinent Years
Description
The final outcome measure for the cost-effectiveness analysis is the ICER (incremental cost-effectiveness ratio), which includes the relevant cost differential between the study arms in the numerator, and the difference in a chosen effectiveness measure in the denominator. 3 types of ICERs will be generated, each one with a different effectiveness measure (engagement in formal addiction treatment at 30 days; quality-adjusted life-years (QALYs) gained; and Abstinent Years). The reason being that different ICERs are more relevant to certain potential stakeholder groups than others.
Time Frame
30 days post randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
RCT Component:
Inclusion Criteria:
Be 18 years or older
Treated in the ED during study screening hours
Meet DSM-5 (Diagnostic and Statistical Manual) diagnostic criteria for moderate to severe OUD
Have a COWS score of > or equal to 4
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.
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.)
Exclusion Criteria:
Have urine toxicology test that is positive for methadone
Be pregnant as determined by human chorionic gonadotropin (hCG) testing at the index ED visit
Have a medical or psychiatric condition that requires hospitalization
Opioid administration (excluding BUP) at the index ED visit, prior to enrollment, and COWS remains < 8 during ED stay
Be actively suicidal or severely cognitively impaired precluding informed consent
Present from an extended care facility (e.g., skilled nursing facility)
Require continued prescription opioids for a pain condition
Be a prisoner or in police custody at the time of index ED visit
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
Be unable to provide reliable locator information including 2 contact numbers in addition to their own
Be unwilling to follow study procedures (e.g., unwilling to provide permission to contact referral provider/program or unavailable for the follow-up assessments)
Have prior enrollment in the current study component
Ancillary Component:
Inclusion Criteria:
Be 18 years or older
Treated in the ED during study screening hours
Meet DSM-5 diagnostic criteria for moderate to severe opioid use disorder
Have a COWS <8
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.
Be able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study
Exclusion Criteria:
Have a urine toxicology test that is positive for methadone
Be pregnant as determined by human chorionic gonadotropin (hCG) testing at the index ED visit
Have a medical or psychiatric condition that requires hospitalization at the index ED visit, prior to enrollment
Be actively suicidal or severely cognitively impaired precluding informed consent
Present from an extended care facility (e.g., skilled nursing facility)
Require continued prescription opioids for a pain condition
Be a prisoner or in police custody at the time of index ED visit
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
Be unable to provide reliable locator information including 2 contact numbers in addition to their own
Be unwilling to follow study procedures (e.g., unwilling to provide permission to answer daily assessments until day 7)
Have prior enrollment in the current study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gail D'Onofrio, MD, MS
Phone
203-785-7059
Email
gail.donofrio@yale.edu
First Name & Middle Initial & Last Name or Official Title & Degree
David Fiellin, MD
Phone
203-737-3347
Email
david.fiellin@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail D'Onofrio, MD, MS
Organizational Affiliation
Yale School of Medicine, Department of Emergency Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Fiellin, MD
Organizational Affiliation
Yale School of Medicine, Department of Internal Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Valleywise Health
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Individual Site Status
Withdrawn
Facility Name
Highland Hospital
City
Oakland
State/Province
California
ZIP/Postal Code
94602
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Herring, MD
Phone
510-437-4800
Email
aherring@alamedahealthsystem.org
First Name & Middle Initial & Last Name & Degree
Andrew Herring, MD
Facility Name
San Leandro Hospital
City
San Leandro
State/Province
California
ZIP/Postal Code
94578
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erik S. Anderson, MD
Phone
510-437-4970
Email
esanderson@alamedahealthsystem.org
First Name & Middle Initial & Last Name & Degree
Erik S. Anderson, MD
Facility Name
Yale New Haven Health (Yale New Haven Hospital)
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gail D'Onofrio, MD, MS
Phone
203-785-7059
Email
gail.donofrio@yale.edu
First Name & Middle Initial & Last Name & Degree
Gail D'Onofrio, MD, MS
First Name & Middle Initial & Last Name & Degree
David Fiellin, MD
First Name & Middle Initial & Last Name & Degree
James Dziura, PhD
First Name & Middle Initial & Last Name & Degree
E. Jennifer Edelman, MD, MHS
First Name & Middle Initial & Last Name & Degree
Kathryn Hawk, MD, MHS
First Name & Middle Initial & Last Name & Degree
Michael Pantalon, PhD
First Name & Middle Initial & Last Name & Degree
R. Andrew Taylor, MD
First Name & Middle Initial & Last Name & Degree
Arjun Venkatesh, MD
First Name & Middle Initial & Last Name & Degree
Patrick O'Connor, MD
First Name & Middle Initial & Last Name & Degree
Edouard Coupet, MD
First Name & Middle Initial & Last Name & Degree
Marek Chawarski, PhD
Facility Name
Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Wilson, MD, MA
Phone
813-844-8160
Email
tampaerdoc@gmail.com
First Name & Middle Initial & Last Name & Degree
Heather Henderson, MA, CAS
Phone
(813) 843-2110
Email
heather42@mail.usf.edu
First Name & Middle Initial & Last Name & Degree
Jason W. Wilson, MD, MA
Facility Name
Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph E. Carpenter, MD
Phone
404-778-1585
Email
joseph.edward.carpenter@emory.edu
First Name & Middle Initial & Last Name & Degree
Joseph E. Carpenter, MD
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Chicago Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael H. Baumann, MD
Email
BAUMAM@mmc.org
First Name & Middle Initial & Last Name & Degree
Tania Strout, PhD, RN, MS
Phone
(207) 661-7611
Email
Strout@mmc.org
First Name & Middle Initial & Last Name & Degree
Michael Baumann, MD
First Name & Middle Initial & Last Name & Degree
Lauren Wendell
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Detroit Receiving Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob James-Third Manteuffel, MD, FACEP
Phone
313-492-5590
Email
jmanteu1@hfhs.org
First Name & Middle Initial & Last Name & Degree
Joseph Miller, MD
Phone
(313) 916-2600
Email
jmiller6@hfhs.org
First Name & Middle Initial & Last Name & Degree
Jacob Manteuffel, MD FACEP
First Name & Middle Initial & Last Name & Degree
Christopher A. Lewandowski, MD
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James R. Miner, MD, FACEP
Phone
612-280-4585
Email
James.Miner@hcmed.org
First Name & Middle Initial & Last Name & Degree
Audrey Hendrickson
Phone
612-873-9528
Email
audrey.hendrickson@hcmed.org
First Name & Middle Initial & Last Name & Degree
James R. Miner, MD, FACEP
First Name & Middle Initial & Last Name & Degree
Lauren R. Klein, MD, MS
Facility Name
Barnes Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Jones, MD
Phone
856-342-2627
Email
jones-christopher@cooperhealth.edu
First Name & Middle Initial & Last Name & Degree
Christopher Jones, MD
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Jones, MD
Facility Name
Presybterian Hospital, Albuquerque, NM
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of New Mexico Hospital
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cameron Crandall, MD
Phone
505-272-5062
Email
ccrandall@salud.unm.edu
First Name & Middle Initial & Last Name & Degree
Cameron Crandall, MD
Facility Name
Bellevue Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Icahn School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Columbia University Irving Medical Center- NY Presbyterian
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Wake Forest School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27101
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Pennsylvania Presbyterian Medical Center/Hospital of UPENN
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeanmarie Perrone, MD
Phone
215-662-6698
Email
perronej@uphs.upenn.edu
First Name & Middle Initial & Last Name & Degree
Jeanmarie Perrone, MD
Facility Name
Temple University Hospital - Episcopal Campus
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19125
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
UPMC Mercy Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Rhode Island Hospital/The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsey Jennings, MD, MPH
Phone
248-535-6108
Email
jennil@musc.edu
First Name & Middle Initial & Last Name & Degree
Carolyn Bogdon, MSN, FNP-BC
Phone
843-792-4507
Email
bogdon@musc.edu
First Name & Middle Initial & Last Name & Degree
Carolyn Bogdon, MSN, FNP-BC
First Name & Middle Initial & Last Name & Degree
Lindsey Jennings, MD, MPH
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tyler W. Barrett, MD
Phone
615-936-0093
Email
tyler.barrett@vumc.org
First Name & Middle Initial & Last Name & Degree
Tyler Barrett, MD
Facility Name
Parkland Memorial Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Utah Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Troy Madsen, MD
Phone
801-581-2417
Email
Troy.Madsen@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Troy Madsen, MD
Facility Name
University of Washington Medical Center- Harborview/Montlake
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Whiteside, MD, MS
Phone
206-744-8464
Email
laurenkw@uw.edu
First Name & Middle Initial & Last Name & Degree
Lauren Whiteside, MD
First Name & Middle Initial & Last Name & Degree
Herbie Duber, MD, MPH
Facility Name
West Virginia University - Berkeley Medical Center
City
Martinsburg
State/Province
West Virginia
ZIP/Postal Code
25401
Country
United States
Individual Site Status
Active, not recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data will be made available after 1) the primary paper has been accepted for publication, or 2) the data is locked for more than 18 months, whichever comes first.
Learn more about this trial
Emergency Department-Initiated Buprenorphine Validation Network Trial
We'll reach out to this number within 24 hrs