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

Opioid-use Disorder Clinical Trial

— COMMIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04180020
• Other study ID #: 2000026223
• Secondary ID: U01TR002763
• Status: Recruiting
• Phase: N/A
• Start date: August 18, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: Yale University
• Contact: Sandra Springer, MD
• Phone: (203) 687-6680
• Email: Sandra.springer[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

Other:
• 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).
• 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.

Locations

Country	Name	City	State
United States	Prisma Health	Greenville	South Carolina
United States	Penn State Health Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention in Medication Treatment for OUD	Enrollment in effective medication treatment for OUD (either buprenorphine maintenance, methadone maintenance, or extended-release naltrexone) will be ascertained through interview of the participant at each assessment point, using a modified, brief version of the Treatment Services Review that records type and dose of medication treatment, contact information on the treatment program, and psychosocial treatment modalities accessed since the previous visit (e.g. professional counseling, 12-step group participation).; The primary outcome will be a binary indicator of whether or not the patient is enrolled on buprenorphine maintenance treatment or other effective medication (methadone maintenance or extended-release naltrexone) at 12 weeks after randomization, verified by either report from the treatment program, or if the treatment program does not respond, prescription drug monitoring report or EMR.	12 weeks
Secondary	Total days of using opioids	This outcome will be measured by Timeline Followback, which assesses self-reported alcohol and other drug use including opioid use route of use and form of drug, for the 30 days before baseline, and for each day over the follow up period, using calendars and memory aids to enhance recall.	4 weeks
Secondary	Total days of using opioids	This outcome will be measured by Timeline Followback, which assesses self-reported alcohol and other drug use including opioid use route of use and form of drug, for the 30 days before baseline, and for each day over the follow up period, using calendars and memory aids to enhance recall.	8 weeks
Secondary	Total days of using opioids	This outcome will be measured by Timeline Followback, which assesses self-reported alcohol and other drug use including opioid use route of use and form of drug, for the 30 days before baseline, and for each day over the follow up period, using calendars and memory aids to enhance recall.	12 weeks
Secondary	Total days of using opioids	This outcome will be measured by Timeline Followback, which assesses self-reported alcohol and other drug use including opioid use route of use and form of drug, for the 30 days before baseline, and for each day over the follow up period, using calendars and memory aids to enhance recall.	24 weeks
Secondary	Negative urine screens: Opioids	This outcome will be measured by urine toxicology-confirmed abstinence via urine toxicology (Manufacturer: Redwood Toxicology) for recent illicit opioid use.	4 weeks
Secondary	Negative urine screens: Opioids	This outcome will be measured by urine toxicology-confirmed abstinence via urine toxicology (Manufacturer: Redwood Toxicology) for recent illicit opioid use.	8 weeks
Secondary	Negative urine screens: Opioids	This outcome will be measured by urine toxicology-confirmed abstinence via urine toxicology (Manufacturer: Redwood Toxicology) for recent illicit opioid use.	12 weeks
Secondary	Negative urine screens: Opioids	This outcome will be measured by urine toxicology-confirmed abstinence via urine toxicology (Manufacturer: Redwood Toxicology) for recent illicit opioid use.	24 weeks
Secondary	Treatment completion rate	This outcome is assessed by the Medical/Infectious Disease/TAU questionnaire. This form documents the completion of antimicrobial therapy and re-hospitalization for infection. The initial evaluation documents the relevant infection and medical details such as infection site, organism, and stage. It also extracts the type of ant-infective, route of administration, dose, and planned duration. Information on follow-up is collected alteration of treatment plan, infection related adverse events (e.g. PICC complications, drug reaction/toxicity to anti-infective agent prescribed by non-study clinicians, etc), and intervening hospitalizations. Completion success is defined as appropriate completion of antimicrobial therapy, as documented in the initial assessment, without interruption or unexpected prolongation of therapy.	4 weeks
Secondary	Treatment completion rate	This outcome is assessed by the Medical/Infectious Disease/TAU questionnaire. This form documents the completion of antimicrobial therapy and re-hospitalization for infection. The initial evaluation documents the relevant infection and medical details such as infection site, organism, and stage. It also extracts the type of ant-infective, route of administration, dose, and planned duration. Information on follow-up is collected alteration of treatment plan, infection related adverse events (e.g. PICC complications, drug reaction/toxicity to anti-infective agent prescribed by non-study clinicians, etc), and intervening hospitalizations. Completion success is defined as appropriate completion of antimicrobial therapy, as documented in the initial assessment, without interruption or unexpected prolongation of therapy.	8 weeks
Secondary	Treatment completion rate	This outcome is assessed by the Medical/Infectious Disease/TAU questionnaire. This form documents the completion of antimicrobial therapy and re-hospitalization for infection. The initial evaluation documents the relevant infection and medical details such as infection site, organism, and stage. It also extracts the type of ant-infective, route of administration, dose, and planned duration. Information on follow-up is collected alteration of treatment plan, infection related adverse events (e.g. PICC complications, drug reaction/toxicity to anti-infective agent prescribed by non-study clinicians, etc), and intervening hospitalizations. Completion success is defined as appropriate completion of antimicrobial therapy, as documented in the initial assessment, without interruption or unexpected prolongation of therapy.	12 weeks
Secondary	Treatment completion rate	This outcome is assessed by the Medical/Infectious Disease/TAU questionnaire. This form documents the completion of antimicrobial therapy and re-hospitalization for infection. The initial evaluation documents the relevant infection and medical details such as infection site, organism, and stage. It also extracts the type of ant-infective, route of administration, dose, and planned duration. Information on follow-up is collected alteration of treatment plan, infection related adverse events (e.g. PICC complications, drug reaction/toxicity to anti-infective agent prescribed by non-study clinicians, etc), and intervening hospitalizations. Completion success is defined as appropriate completion of antimicrobial therapy, as documented in the initial assessment, without interruption or unexpected prolongation of therapy.	24 weeks
Secondary	Re-hospitalization/Emergency room visits	Re-hospitalizations and emergency room presentations related to either their infectious disease or OUD will be totaled over the intervention duration and 12-week follow-up period.	12 weeks
Secondary	Re-hospitalization/Emergency room visits	Re-hospitalizations and emergency room presentations related to either their infectious disease or OUD will be totaled over the intervention duration and 12-week follow-up period.	24 weeks
Secondary	Quality of life measure of social and occupational functioning	Quality of life is measured using the WHOQOL-Bref, which is a is a well validated and widely used scale for persons with substance use disorders that measures the quality of social and occupational functioning as well as other domains. Scores are scaled in a positive direction (higher scores indicate a higher quality of life). A total of 500 is the highest score attainable and indicates highest quality of life in respondents.	12 weeks
Secondary	Quality of life measure of social and occupational functioning	Quality of life is measured using the WHOQOL-Bref, which is a is a well validated and widely used scale for persons with substance use disorders that measures the quality of social and occupational functioning as well as other domains. Scores are scaled in a positive direction (higher scores indicate a higher quality of life). A total of 500 is the highest score attainable and indicates highest quality of life in respondents.	24 weeks