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Coordinated Medical Management for Opioid Use Disorder (COMMIT Trial)
N/A
Recruiting
Led By Sandra Springer, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
COMMIT Trial Summary
This trial will test a new model of care for people with opioid use disorder who also have infections. The ID/LAB model will have ID specialists and hospitalists manage the OUD and infections concurrently, using long-acting injectable buprenorphine. After discharge, patients will be referred to community resources for long term treatment of OUD.
Who is the study for?
This trial is for adults hospitalized with certain infections who also have moderate-to-severe opioid use disorder (OUD). Participants must be able to consent and willing to follow up after discharge. It's not for pregnant or breastfeeding women, those with severe medical/psychiatric issues, allergies to buprenorphine, serious liver problems, or those already effectively treated for OUD.Check my eligibility
What is being tested?
Project COMMIT tests a care model where infectious disease specialists manage both OUD-related infections and the addiction itself using long-acting injectable buprenorphine (LAB), compared to traditional treatment as usual (TAU). The goal is coordinated care during hospitalization followed by community support.See study design
What are the potential side effects?
While specific side effects are not listed here, long-acting injectable buprenorphine can typically cause pain at the injection site, nausea, headache, dizziness, fatigue, constipation among others. Side effects vary from person to person.
COMMIT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently hospitalized with a suspected or known serious infection.
COMMIT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Retention in Medication Treatment for OUD
Secondary outcome measures
Negative urine screens: Opioids
Quality of life measure of social and occupational functioning
Re-hospitalization/Emergency room visits
+2 moreCOMMIT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ID/LABExperimental Treatment1 Intervention
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
Group II: TAUActive Control1 Intervention
Treatment as Usual (TAU).
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Who is running the clinical trial?
Yale UniversityLead Sponsor
1,848 Previous Clinical Trials
2,737,618 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
321 Previous Clinical Trials
401,549 Total Patients Enrolled
Sandra Springer, MDPrincipal InvestigatorYale School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently on and plan to continue methadone or buprenorphine treatment.I am currently hospitalized with a suspected or known serious infection.You currently have a moderate-to-severe opioid use disorder.I am allergic or have a bad reaction to buprenorphine.My doctor thinks my liver is not working well.I can give my consent in English or Spanish.
Research Study Groups:
This trial has the following groups:- Group 1: ID/LAB
- Group 2: TAU
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has recruitment for this study been completed yet?
"Yes, clinicaltrials.gov confirms that this clinical trial is currently enrolling participants. This medical experiment was initiated on August 18th 2020 and updated last November 16th 2021 with a goal of recruiting 200 patients from 3 different sites."
Answered by AI
What is the aggregate amount of participants in this investigation?
"To successfully complete the trial, 200 qualified individuals are required. Potential candidates can join either at Yale New Haven Hospital in Connecticut or Penn State Health Milton S. Hershey Medical Center in Pennsylvania."
Answered by AI
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