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

NCT ID: NCT04180020

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 171 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-18
• Study Completion Date: 2024-04-25

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.

Detailed Description

There are three specific aims that this study will use to assess a new model of care aimed at treating opioid use disorder (OUD). These aims address whether treatment is maintained by patients, if patients' opioid use outcomes improve and to determine if adherence to treatment for infectious disease results in fewer re-hospitalizations and emergency room visits, as well as improved quality of life.

The specific aims:

Aim1: The primary outcome will be a binary indicator of whether a patient is enrolled in and receiving effective medication treatment for OUD (buprenorphine, methadone, or injection naltrexone) at 12 weeks (3 months) after randomization.

Aim 2: Evidence of improved opioid use outcomes (lower days of using opioids, negative urine opioids).

Aim 3: Have higher rates of completion of the antimicrobial regimen for their infectious disease, decreased re-hospitalizations and emergency room presentations related to either their infectious disease or OUD over the 12-week follow-up period, and improved measures of quality of life.

The intent of this study is to test the hypothesis:

Assignment to the ID/LAB arm (OUD managed directly by the infectious disease (ID) specialists or hospitalist team with long acting injection buprenorphine (LAB)) will promote greater enrollment in effective medication treatment for OUD at 12 weeks after randomization, compared to TAU.

Conditions

Opioid-use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAU

Treatment as Usual (TAU).

Group Type: ACTIVE_COMPARATOR

TAU

Intervention Type: 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.

ID/LAB

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

Group Type: EXPERIMENTAL

ID/LAB

Intervention Type: 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).

Interventions

ID/LAB

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).

Intervention Type: OTHER

TAU

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandra Springer, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale New Haven Hospital

New Haven, Connecticut, United States

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Prisma Health

Greenville, South Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40445619 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

U01TR002763

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000026223

Identifier Type: -

Identifier Source: org_study_id