N/A N=171 Randomized Treatment

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

Opioid-use Disorder

Bottom Line

View on ClinicalTrials.gov: NCT04180020 ↗

Enrolled (actual)

171

Serious AEs

29.8%

Results posted

Apr 2025

Primary outcome: Primary: Number of Participants With Retention in Medication Treatment for OUD — 46; 51 Participants — p=0.94

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ID/LAB (Other); TAU (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Yale University
Primary completion: Feb 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Retention in Medication Treatment for OUD	46; 51	0.94
SECONDARY Total Days of Using Opioids	—	—
SECONDARY Total Days of Using Opioids	—	—
SECONDARY Total Days of Using Opioids	—	—
SECONDARY Total Days of Using Opioids	—	—
SECONDARY Negative Urine Screens: Opioids	—	—
SECONDARY Negative Urine Screens: Opioids	—	—
SECONDARY Negative Urine Screens: Opioids	—	—
SECONDARY Negative Urine Screens: Opioids	—	—
SECONDARY Treatment Completion Rate	—	—
SECONDARY Treatment Completion Rate	—	—
SECONDARY Treatment Completion Rate	—	—
SECONDARY Treatment Completion Rate	—	—
SECONDARY Re-hospitalization/Emergency Room Visits	—	—
SECONDARY Re-hospitalization/Emergency Room Visits	—	—
SECONDARY Quality of Life Measure of Social and Occupational Functioning	—	—
SECONDARY Quality of Life Measure of Social and Occupational Functioning	—	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04180020). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.