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

Yale University

Status: Completed

Conditions: Opioid-use Disorder

Treatments: Other: ID/LAB; Other: TAU

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04180020

U01TR002763 (U.S. NIH Grant/Contract)

2000026223

Details and patient eligibility

About

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.

Full 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.

Enrollment: 171 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

171 participants in 2 patient groups

TAU

Active Comparator group

Description:

Treatment as Usual (TAU).

Treatment:

Other: TAU

ID/LAB

Experimental group

Description:

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

Treatment:

Other: ID/LAB