Emergency Department-Initiated Buprenorphine Validation Network Trial

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.

Conditions

• Opioid-use Disorder

Interventions

DRUG

CAM2038

Patients will receive a 24 mg dose of injectable CAM2038 in the ED on Day 0.

DRUG

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.

Sponsors & Collaborators

• National Drug Abuse Treatment Clinical Trials Network

  collaborator NETWORK

• The Emmes Company, LLC

  collaborator INDUSTRY

• Harvard Medical School (HMS and HSDM)

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• NYU Langone Health

  collaborator OTHER

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

• Alameda Health System

  collaborator OTHER

• Weill Medical College of Cornell University

  collaborator OTHER

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Yale University

  lead OTHER

Principal Investigators

• Gail D'Onofrio, MD, MS · Yale School of Medicine, Department of Emergency Medicine

• David Fiellin, MD · Yale School of Medicine, Department of Internal Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-07-08

Primary Completion

2024-12-06

Completion

2024-12-06

FDA Drug

Yes

Countries

• United States

Study Locations