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Completed

NCT Number: NCT04180020

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

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.

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Key information

Conditions

Opioid-use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale New Haven Hospital, New Haven, Connecticut, United States

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About this study

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.

Secondary Outcome measures were updated at time of results entry.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ID/LAB

Other

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

Other

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 outcomes

  1. Number of Participants With Retention in Medication Treatment for OUD

    Time frame: 12 weeks

    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 outcomes

  1. Days of Using Opioids

    Time frame: 4 weeks

    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 using calendars and memory aids to enhance recall.

  2. Days of Using Opioids

    Time frame: From Week 4 to 8

    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 since the last assessment, using calendars and memory aids to enhance recall.

  3. Days of Using Opioids

    Time frame: From Week 8 to 12

    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 since the last assessment, using calendars and memory aids to enhance recall.

  4. Days of Using Opioids

    Time frame: 24 weeks

    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 using calendars and memory aids to enhance recall.

  5. Negative Urine Screens: Opioids

    Time frame: 1 week

    This outcome will be measured by the number of participants with urine toxicology-confirmed abstinence via urine toxicology (Manufacturer: Redwood Toxicology) for recent illicit opioid use.

  6. Negative Urine Screens: Opioids

    Time frame: 4 weeks

    This outcome will be measured by the number of participants with urine toxicology-confirmed abstinence via urine toxicology (Manufacturer: Redwood Toxicology) for recent illicit opioid use.

  7. Negative Urine Screens: Opioids

    Time frame: 8 weeks

    This outcome will be measured by the number of participants with urine toxicology-confirmed abstinence via urine toxicology (Manufacturer: Redwood Toxicology) for recent illicit opioid use.

  8. Negative Urine Screens: Opioids

    Time frame: 12 weeks

    This outcome will be measured by the number of participants with urine toxicology-confirmed abstinence via urine toxicology (Manufacturer: Redwood Toxicology) for recent illicit opioid use.

  9. Negative Urine Screens: Opioids

    Time frame: 24 weeks

    This outcome will be measured by the number of participants with urine toxicology-confirmed abstinence via urine toxicology (Manufacturer: Redwood Toxicology) for recent illicit opioid use.

  10. Treatment Completion

    Time frame: 12 weeks

    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. Data presented here is the number of participants that successfully completed treatment.

  11. Re-hospitalization/Emergency Room Visits

    Time frame: 12 weeks

    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. These data are operationalized as the total number of patients experiencing rehospitalization by 12 Weeks.

  12. Quality of Life Measure of Social and Occupational Functioning

    Time frame: 12 weeks

    Quality of life is measured using the World Health Organization Quality Of Life short tool (WHOQOL-Bref), which is a is a well validated and widely used 26-question tool for persons with substance use disorders that measures the perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. Scores range from a minimum of 0 to a maximum of 130. Higher scores indicate a higher quality of life.

  13. Quality of Life Measure of Social and Occupational Functioning

    Time frame: 24 weeks

    Quality of life is measured using the World Health Organization Quality Of Life short tool (WHOQOL-Bref), which is a is a well validated and widely used 26-question tool for persons with substance use disorders that measures the perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. Scores range from a minimum of 0 to a maximum of 130. Higher scores indicate a higher quality of life.

  14. Mean Modified PEG Pain Scale Score

    Time frame: 4 weeks

    A modified version of the Brief Pain Inventory (BPI), focusing on pain intensity and interference with enjoyment of life and general activity. Total score range 0-10 with higher scores indicating greater pain and interference.

  15. Mean Modified PEG Pain Scale Score

    Time frame: 8 weeks

    A modified version of the Brief Pain Inventory (BPI), focusing on pain intensity and interference with enjoyment of life and general activity. Total score range 0-10 with higher scores indicating greater pain and interference.

  16. Mean Modified PEG Pain Scale Score

    Time frame: 12 weeks

    A modified version of the Brief Pain Inventory (BPI), focusing on pain intensity and interference with enjoyment of life and general activity. Total score range 0-10 with higher scores indicating greater pain and interference.

  17. Mean Modified PEG Pain Scale Score

    Time frame: 24 weeks

    A modified version of the Brief Pain Inventory (BPI), focusing on pain intensity and interference with enjoyment of life and general activity. Total score range 0-10 with higher scores indicating greater pain and interference.

  18. Number of Participants Who Had Sex Without a Condom in the Past 28 Days to Assess HIV Risk Behavior

    Time frame: 4 Weeks

    Number of Participants Who Had Vaginal or Anal Sex Without a Condom in the Past 28 days

  19. Number of Participants Who Had Sex Without a Condom in the Past 28 Days to Assess HIV Risk Behavior

    Time frame: 8 Weeks

    Number of Participants Who Had Vaginal or Anal Sex Without a Condom in the Past 28 days

  20. Number of Participants Who Had Sex Without a Condom in the Past 28 Days to Assess HIV Risk Behavior

    Time frame: 12 Weeks

    Number of Participants Who Had Vaginal or Anal Sex Without a Condom in the Past 28 days

  21. Number of Participants Who Had Sex Without a Condom in the Past 28 Days to Assess HIV Risk Behavior

    Time frame: 24 Weeks

    Number of Participants Who Had Vaginal or Anal Sex Without a Condom in the Past 28 days

  22. Number of Participants Who Had A Needle Sharing Activity in the Past 28 Days to Assess HIV Risk Behavior

    Time frame: 4 Weeks

    Number of Participants Who Had A Needle Sharing Activity in the Past 28 days

  23. Number of Participants Who Had A Needle Sharing Activity in the Past 28 Days to Assess HIV Risk Behavior

    Time frame: 8 Weeks

    Number of Participants Who Had A Needle Sharing Activity in the Past 28 days

  24. Number of Participants Who Had A Needle Sharing Activity in the Past 28 Days to Assess HIV Risk Behavior

    Time frame: 12 Weeks

    Number of Participants Who Had A Needle Sharing Activity in the Past 28 days

  25. Number of Participants Who Had A Needle Sharing Activity in the Past 28 Days to Assess HIV Risk Behavior

    Time frame: 24 Weeks

    Number of Participants Who Had A Needle Sharing Activity in the Past 28 days

  26. Treatment Satisfaction

    Time frame: 12 Weeks

    Participants were asked if they were currently satisfied with their MOUD (Medication for Opioid Use Disorder). Responses were Yes / No.

  27. Treatment Satisfaction

    Time frame: 24 Weeks

    Participants were asked if they were currently satisfied with their MOUD (Medication for Opioid Use Disorder). Responses were Yes / No.

  28. Unplanned Medical Discharge

    Time frame: baseline

    Number of participants that had an Unplanned Medical Discharge at baseline

  29. Cure of Index Infection

    Time frame: 12 Weeks

    Number of participants cured of index infection. Clinical adjudication was made based on EHR review including documentation from treating providers, laboratory analyses, available microbiologic information, and imaging.

  30. Number of Participants With Hepatitis C (HCV) Detectable Viral Load

    Time frame: 12 Weeks

    Number of participants with HCV detectable viral load, as determined through RNA polymerase chain reaction (PCR) testing. A viral load above 15 international units per liter (IU/L) is considered detectable and is an indication of active infection and that treatment should be considered

  31. Number of Participants With Detectable HIV Viral Load

    Time frame: up to 12 Weeks

    Number of participants with a viral load by nucleic acid amplification test of more than 200 IU/mL, of those with HIV. A viral load of 200 copies/mL or less is considered 'undetectable' with no risk of HIV transmission.

  32. Mean Days Injecting Drugs

    Time frame: 4 weeks

    Mean days participants have injected drugs in the last 28 days

  33. Mean Days Injecting Drugs

    Time frame: 8 weeks

    Mean days participants have injected drugs in the last 28 days

  34. Mean Days Injecting Drugs

    Time frame: 12 weeks

    Mean days participants have injected drugs in the last 28 days

  35. Mean Days Injecting Drugs

    Time frame: 24 weeks

    Mean days participants have injected drugs in the last 28 days

  36. Mean Days Other Drug Use

    Time frame: 4 weeks

    Mean days using other drugs/alcohol (including THC) in last 28 days by self-report

  37. Mean Days Other Drug Use

    Time frame: 8 weeks

    Mean days using other drugs/alcohol (including THC) in last 28 days by self-report

  38. Mean Days Other Drug Use

    Time frame: 12 weeks

    Mean days using other drugs/alcohol (including THC) in last 28 days by self-report

  39. Mean Days Other Drug Use

    Time frame: 24 weeks

    Mean days using other drugs/alcohol (including THC) in last 28 days by self-report

  40. Urine Toxicology: Positive Screens

    Time frame: 4 weeks

    Number of participants with Urine toxicology positive for non-opioid drugs (including THC)

  41. Urine Toxicology: Positive Screens

    Time frame: 8 weeks

    Number of participants with Urine toxicology positive for non-opioid drugs (including THC)

  42. Urine Toxicology: Positive Screens

    Time frame: 12 weeks

    Number of participants with Urine toxicology positive for non-opioid drugs (including THC)

  43. Urine Toxicology: Positive Screens

    Time frame: 24 weeks

    Number of participants with Urine toxicology positive for non-opioid drugs (including THC)

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Acronym: COMMIT

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Nov 27, 2019
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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