Buprenorphine for Opioid Use Disorder

Recruiting in Palo Alto (17 mi)

+34 other locations

Overseen by David Fiellin, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Yale University

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Gail D'Onofrio, MD, MS

Principal Investigator

Yale School of Medicine, Department of Emergency Medicine

David Fiellin, MD

Principal Investigator

Yale School of Medicine, Department of Internal Medicine

Eligibility Criteria

Adults who visit the emergency department (ED) with moderate to severe opioid use disorder, not currently on medication-assisted treatment, and have a certain level of withdrawal symptoms are eligible. They must speak English or Spanish at sites with translated materials, provide contact information for follow-up, and consent to study procedures.

Inclusion Criteria

Be unable to provide reliable locator information including 2 contact numbers in addition to their own

I tested positive for opioids, but not just fentanyl, and meet the criteria for moderate to severe opioid use disorder.

You have a significant addiction to opioids that has been diagnosed using specific criteria.

Exclusion Criteria

Have prior enrollment in the current study component

I was given opioids (not BUP) in the ED and my withdrawal symptoms were mild.

I am willing to follow all study procedures and attend follow-up assessments.

Treatment Details

Interventions

• Buprenorphine Sublingual Product (Opioid Partial Agonist)
• CAM2038 (Opioid Partial Agonist)

Trial Overview The trial is testing two forms of buprenorphine: sublingual (under the tongue) versus extended-release (long-acting injection), to see which is more effective in engaging patients in addiction treatment one week after an ED visit. It includes training EDs across the U.S., randomizing participants into groups, and validating electronic health record data.

Participant Groups

Group I: XR-BUP Experimental Treatment 1 Intervention

Injectable buprenorphine

Group II: Standard SL-BUP Active Control 1 Intervention

Sublingual buprenorphine

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Washington Medical Center- Harborview/Montlake Seattle, WA

Medical University of South Carolina Charleston, SC

Cooper University Hospital Camden, NJ

University of Chicago Medicine Chicago, IL

More Trial Locations

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1963

Patients Recruited

3,046,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2658

Patients Recruited

3,409,000+

University of Pennsylvania

Collaborator

Trials

2118

Patients Recruited

45,270,000+

NYU Langone Health

Collaborator

Trials

1431

Patients Recruited

838,000+

Icahn School of Medicine at Mount Sinai

Collaborator

Trials

933

Patients Recruited

579,000+

Harvard Medical School (HMS and HSDM)

Collaborator

Trials

208

Patients Recruited

1,421,000+

The Emmes Company, LLC

Industry Sponsor

Trials

149

Patients Recruited

1,052,000+

National Drug Abuse Treatment Clinical Trials Network

Collaborator

Trials

7

Patients Recruited

3,000+

Weill Medical College of Cornell University

Collaborator

Trials

1103

Patients Recruited

1,157,000+

Alameda Health System

Collaborator

Trials

9

Patients Recruited

4,100+