Overview

Emergency Department-Initiated Buprenorphine Validation Network Trial

Status:
Recruiting

Trial end date:
2023-08-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Yale University

Collaborators:

Alameda Health System
Harvard Medical School
Harvard Medical School (HMS and HSDM)
Icahn School of Medicine at Mount Sinai
National Drug Abuse Treatment Clinical Trials Network
NYU Langone Health
The Emmes Company, LLC
University of Pennsylvania
Weill Medical College of Cornell University

Treatments:

Buprenorphine

Criteria

RCT Component:

Inclusion Criteria:

1. Be 18 years or older

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.)

Exclusion Criteria:

1. Have 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

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:

Inclusion Criteria:

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:

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