Clinical trial NCT04180020: Coordinating Opioid Use Treatment Through Medical Management With Infection Treatment (Project COMMIT)
Official title: Coordinating Opioid Use Treatment Through Medical Management With Infection Treatment (Project COMMIT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2019-11-27
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants With Retention in Medication Treatment for OUD
timeFrame: 12 weeks
Secondary outcomes:
measure: Total Days of Using Opioids
timeFrame: 4 weeks
measure: Total Days of Using Opioids
timeFrame: 8 weeks
measure: Total Days of Using Opioids
timeFrame: 12 weeks
measure: Total Days of Using Opioids
timeFrame: 24 weeks
measure: Negative Urine Screens: Opioids
timeFrame: 4 weeks
measure: Negative Urine Screens: Opioids
timeFrame: 8 weeks
measure: Negative Urine Screens: Opioids
timeFrame: 12 weeks
measure: Negative Urine Screens: Opioids
timeFrame: 24 weeks
measure: Treatment Completion Rate
timeFrame: 4 weeks
measure: Treatment Completion Rate
timeFrame: 8 weeks
measure: Treatment Completion Rate
timeFrame: 12 weeks
measure: Treatment Completion Rate
timeFrame: 24 weeks
measure: Re-hospitalization/Emergency Room Visits
timeFrame: 12 weeks
measure: Re-hospitalization/Emergency Room Visits
timeFrame: 24 weeks
measure: Quality of Life Measure of Social and Occupational Functioning
timeFrame: 12 weeks
measure: Quality of Life Measure of Social and Occupational Functioning
timeFrame: 24 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Hershey
country: United States
facility: Penn State Health Milton S. Hershey Medical Center
state: Pennsylvania
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
Study officials:
affiliation: Yale University
name: Sandra Springer, MD
role: PRINCIPAL_INVESTIGATOR
References: