Coordinating Opioid Use Treatment Through Medical Management With Infection Treatment (Project COMMIT) (COMMIT)
Primary Purpose
Opioid-use Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ID/LAB
TAU
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-use Disorder
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.
Sites / Locations
- Yale New Haven HospitalRecruiting
- Penn State Health Milton S. Hershey Medical CenterRecruiting
- Prisma HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
TAU
ID/LAB
Arm Description
Treatment as Usual (TAU).
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Quality of life
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.
Quality of life
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.
Full Information
NCT ID
NCT04180020
First Posted
November 25, 2019
Last Updated
April 21, 2023
Sponsor
Yale University
Collaborators
National Center for Advancing Translational Sciences (NCATS)
1. Study Identification
Unique Protocol Identification Number
NCT04180020
Brief Title
Coordinating Opioid Use Treatment Through Medical Management With Infection Treatment (Project COMMIT)
Acronym
COMMIT
Official Title
Coordinating Opioid Use Treatment Through Medical Management With Infection Treatment (Project COMMIT)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 18, 2020 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Center for Advancing Translational Sciences (NCATS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TAU
Arm Type
Active Comparator
Arm Description
Treatment as Usual (TAU).
Arm Title
ID/LAB
Arm Type
Experimental
Arm Description
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
Intervention Type
Other
Intervention Name(s)
ID/LAB
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
TAU
Intervention Description
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.
Primary Outcome Measure Information:
Title
Retention in Medication Treatment for OUD
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Total days of using opioids
Description
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.
Time Frame
4 weeks
Title
Total days of using opioids
Description
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.
Time Frame
8 weeks
Title
Total days of using opioids
Description
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.
Time Frame
12 weeks
Title
Total days of using opioids
Description
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.
Time Frame
24 weeks
Title
Negative urine screens: Opioids
Description
This outcome will be measured by urine toxicology-confirmed abstinence via urine toxicology (Manufacturer: Redwood Toxicology) for recent illicit opioid use.
Time Frame
4 weeks
Title
Negative urine screens: Opioids
Description
This outcome will be measured by urine toxicology-confirmed abstinence via urine toxicology (Manufacturer: Redwood Toxicology) for recent illicit opioid use.
Time Frame
8 weeks
Title
Negative urine screens: Opioids
Description
This outcome will be measured by urine toxicology-confirmed abstinence via urine toxicology (Manufacturer: Redwood Toxicology) for recent illicit opioid use.
Time Frame
12 weeks
Title
Negative urine screens: Opioids
Description
This outcome will be measured by urine toxicology-confirmed abstinence via urine toxicology (Manufacturer: Redwood Toxicology) for recent illicit opioid use.
Time Frame
24 weeks
Title
Treatment completion rate
Description
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.
Time Frame
4 weeks
Title
Treatment completion rate
Description
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.
Time Frame
8 weeks
Title
Treatment completion rate
Description
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.
Time Frame
12 weeks
Title
Treatment completion rate
Description
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.
Time Frame
24 weeks
Title
Re-hospitalization/Emergency room visits
Description
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.
Time Frame
12 weeks
Title
Re-hospitalization/Emergency room visits
Description
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.
Time Frame
24 weeks
Title
Quality of life
Description
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.
Time Frame
12 weeks
Title
Quality of life
Description
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.
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra Springer, MD
Phone
(203) 687-6680
Email
Sandra.springer@yale.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Cynthia Frank, PhD, RN
Phone
(203) 785-6939
Email
cyndi.frank@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Springer, MD
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Recruiting
Facility Name
Penn State Health Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Name
Prisma Health
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Coordinating Opioid Use Treatment Through Medical Management With Infection Treatment (Project COMMIT)
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