Coordinating Opioid Use Treatment Through Medical Management With Infection Treatment (Project COMMIT)

NCT04180020 | Completed Results DMC

• 2 other identifiers: 2000026223U01TR002763
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 3

Brief Summary

This study seeks to test a new model of care (ID/LAB) in which opioid use disorder (OUD) is managed by infectious disease (ID) specialists and hospitalists concurrent with management of the OUD-related infections, using long-acting injectable buprenorphine (LAB), followed by referral as soon as possible after hospital discharge to community resources for long term treatment of OUD.

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Retention in Medication Treatment for OUD

  Enrollment in effective medication treatment for OUD (either buprenorphine maintenance, methadone maintenance, or extended-release naltrexone) will be ascertained through interview of the participant at each assessment point, using a modified, brief version of the Treatment Services Review that records type and dose of medication treatment, contact information on the treatment program, and psychosocial treatment modalities accessed since the previous visit (e.g. professional counseling, 12-step group participation). The primary outcome will be a binary indicator of whether or not the patient is enrolled on buprenorphine maintenance treatment or other effective medication (methadone maintenance or extended-release naltrexone) at 12 weeks after randomization, verified by either report from the treatment program, or if the treatment program does not respond, prescription drug monitoring report or EMR.

  12 weeks

Secondary Outcomes (16)

• Total Days of Using Opioids

  4 weeks

• Total Days of Using Opioids

  8 weeks

• Total Days of Using Opioids

  12 weeks

• Total Days of Using Opioids

  24 weeks

• Negative Urine Screens: Opioids

  4 weeks

Study Arms (2)

TAU

ACTIVE COMPARATOR

Treatment as Usual (TAU).

Other: TAU

ID/LAB

EXPERIMENTAL

Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).

Other: ID/LAB

Interventions

ID/LAB OTHER

ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).

ID/LAB

TAU OTHER

TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.

TAU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults able to provide written informed consent in English or Spanish;
• Current hospitalization with a suspected or known bacterial or viral (HIV/HCV/HBV) infection including but not limited to bacteremia, Candidal fungemia, osteomyelitis, endophthalmitis, septic thrombophlebitis, infected pseudoaneurysm, endocarditis, skin/soft tissue infection (SSTI), or septic arthritis;
• Current moderate-to-severe OUD (DSM-5);
• Willing to accept assignment to either ID/LAB or TAU, and to participate in research follow-up visits.

You may not qualify if:

• Severe medical or psychiatric disability making participation unsafe (e.g. imminent suicide risk);
• Pregnancy, planning conception, or breast-feeding for female participants;
• Allergy, hypersensitivity or medical contraindication to buprenorphine;
• Moderate-severe liver impairment in the judgment of the study investigator;
• Preexisting enrollment on methadone or buprenorphine (SL-B) maintenance AND intending to remain on methadone or buprenorphine maintenance upon discharge (patients already under effective treatment for OUD do not represent the target population of untreated OUD patients entering hospitals, nor would we want to disrupt established effective treatment).
• Inability or unwillingness of subject to give informed consent.

Sponsors & Collaborators

• Yale University: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (3)

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Prisma Health

Greenville, South Carolina, 29650, United States

Location

Related Publications (1)

• Seval N, Roth P, Frank CA, Di Paola A, Litwin AH, Vander Wyk B, Neirinckx V, Schlossberg E, Lawson P, Strong M, Schade MA, Nunez J, Levin FR, Brady KT, Nunes EV, Springer SA. Initiating Injectable Buprenorphine in People Hospitalized With Infections: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2513000. doi: 10.1001/jamanetworkopen.2025.13000.

  PMID: 40445619 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Sandra Springer, MD
• Organization: Yale School of Medicine

sandra.springer@yale.edu

877-554-3578

Study Officials

• Sandra Springer, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: November 27, 2019
• Study Start: August 18, 2020
• Primary Completion: February 6, 2024
• Study Completion: April 25, 2024
• Last Updated: April 3, 2025
• Results First Posted: April 3, 2025

Record last verified: 2025-03

Locations

US (3)