Opioid-use DisorderCOMMITNCT04180020
Coordinating Opioid Use Treatment Through Medical Management With Infection Treatment (Project COMMIT)
A study testing ID/LAB and TAU in people with Opioid-use Disorder, run by Yale University at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- ID/LAB and TAU
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Aug 2020to 25 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Prisma Health
Greenville, South Carolina, 29650
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Yale New Haven Hospital
New Haven, Connecticut, 06520
About this study
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.
Read the 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.
Secondary Outcome measures were updated at time of results entry.
- Conditions
- Opioid-use Disorder
- Being tested
- ID/LAB, TAU
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ID/LABOther
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).
TAUOther
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.
| Study group | Role | What they receive |
|---|---|---|
| TAU | Active comparator | Treatment as Usual (TAU). Receives: Other: TAU |
| ID/LAB | Experimental | Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB). Receives: Other: ID/LAB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With 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.
Measured: 12 weeks
Secondary outcomes (43)
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 using calendars and memory aids to enhance recall.
Measured: 4 weeks
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 since the last assessment, using calendars and memory aids to enhance recall.
Measured: From Week 4 to 8
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 since the last assessment, using calendars and memory aids to enhance recall.
Measured: From Week 8 to 12
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 using calendars and memory aids to enhance recall.
Measured: 24 weeks
Negative Urine Screens: Opioids
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.
Measured: 1 week
Negative Urine Screens: Opioids
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.
Measured: 4 weeks
Negative Urine Screens: Opioids
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.
Measured: 8 weeks
Negative Urine Screens: Opioids
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.
Measured: 12 weeks
Negative Urine Screens: Opioids
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.
Measured: 24 weeks
Treatment Completion
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.
Measured: 12 weeks
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. These data are operationalized as the total number of patients experiencing rehospitalization by 12 Weeks.
Measured: 12 weeks
Quality of Life Measure of Social and Occupational Functioning
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.
Measured: 12 weeks
Quality of Life Measure of Social and Occupational Functioning
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.
Measured: 24 weeks
Mean Modified PEG Pain Scale Score
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.
Measured: 4 weeks
Mean Modified PEG Pain Scale Score
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.
Measured: 8 weeks
Mean Modified PEG Pain Scale Score
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.
Measured: 12 weeks
Mean Modified PEG Pain Scale Score
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.
Measured: 24 weeks
Number of Participants Who Had Sex Without a Condom in the Past 28 Days to Assess HIV Risk Behavior
Number of Participants Who Had Vaginal or Anal Sex Without a Condom in the Past 28 days
Measured: 4 Weeks
Number of Participants Who Had Sex Without a Condom in the Past 28 Days to Assess HIV Risk Behavior
Number of Participants Who Had Vaginal or Anal Sex Without a Condom in the Past 28 days
Measured: 8 Weeks
Number of Participants Who Had Sex Without a Condom in the Past 28 Days to Assess HIV Risk Behavior
Number of Participants Who Had Vaginal or Anal Sex Without a Condom in the Past 28 days
Measured: 12 Weeks
Number of Participants Who Had Sex Without a Condom in the Past 28 Days to Assess HIV Risk Behavior
Number of Participants Who Had Vaginal or Anal Sex Without a Condom in the Past 28 days
Measured: 24 Weeks
Number of Participants Who Had A Needle Sharing Activity in the Past 28 Days to Assess HIV Risk Behavior
Number of Participants Who Had A Needle Sharing Activity in the Past 28 days
Measured: 4 Weeks
Number of Participants Who Had A Needle Sharing Activity in the Past 28 Days to Assess HIV Risk Behavior
Number of Participants Who Had A Needle Sharing Activity in the Past 28 days
Measured: 8 Weeks
Number of Participants Who Had A Needle Sharing Activity in the Past 28 Days to Assess HIV Risk Behavior
Number of Participants Who Had A Needle Sharing Activity in the Past 28 days
Measured: 12 Weeks
Number of Participants Who Had A Needle Sharing Activity in the Past 28 Days to Assess HIV Risk Behavior
Number of Participants Who Had A Needle Sharing Activity in the Past 28 days
Measured: 24 Weeks
Treatment Satisfaction
Participants were asked if they were currently satisfied with their MOUD (Medication for Opioid Use Disorder). Responses were Yes / No.
Measured: 12 Weeks
Treatment Satisfaction
Participants were asked if they were currently satisfied with their MOUD (Medication for Opioid Use Disorder). Responses were Yes / No.
Measured: 24 Weeks
Unplanned Medical Discharge
Number of participants that had an Unplanned Medical Discharge at baseline
Measured: baseline
Cure of Index Infection
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.
Measured: 12 Weeks
Number of Participants With Hepatitis C (HCV) Detectable Viral Load
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
Measured: 12 Weeks
Number of Participants With Detectable HIV Viral Load
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.
Measured: up to 12 Weeks
Mean Days Injecting Drugs
Mean days participants have injected drugs in the last 28 days
Measured: 4 weeks
Mean Days Injecting Drugs
Mean days participants have injected drugs in the last 28 days
Measured: 8 weeks
Mean Days Injecting Drugs
Mean days participants have injected drugs in the last 28 days
Measured: 12 weeks
Mean Days Injecting Drugs
Mean days participants have injected drugs in the last 28 days
Measured: 24 weeks
Mean Days Other Drug Use
Mean days using other drugs/alcohol (including THC) in last 28 days by self-report
Measured: 4 weeks
Mean Days Other Drug Use
Mean days using other drugs/alcohol (including THC) in last 28 days by self-report
Measured: 8 weeks
Mean Days Other Drug Use
Mean days using other drugs/alcohol (including THC) in last 28 days by self-report
Measured: 12 weeks
Mean Days Other Drug Use
Mean days using other drugs/alcohol (including THC) in last 28 days by self-report
Measured: 24 weeks
Urine Toxicology: Positive Screens
Number of participants with Urine toxicology positive for non-opioid drugs (including THC)
Measured: 4 weeks
Urine Toxicology: Positive Screens
Number of participants with Urine toxicology positive for non-opioid drugs (including THC)
Measured: 8 weeks
Urine Toxicology: Positive Screens
Number of participants with Urine toxicology positive for non-opioid drugs (including THC)
Measured: 12 weeks
Urine Toxicology: Positive Screens
Number of participants with Urine toxicology positive for non-opioid drugs (including THC)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start18 Aug 2020
- Primary completion6 Feb 2024
- Study completion25 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Sandra Springer, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180020
- Sponsor's protocol ID
- 2000026223
- Other IDs
- U01TR002763
- Acronym
- COMMIT
- Status last verified
- Jun 2026
- First submitted
- 25 Nov 2019
- Last updated
- 14 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Seval N, Roth P, Frank CA, Di Paola A, Litwin AH, Vander Wyk B, Neirinckx V, Schlossberg E, Lawson P, Strong M, Schade MA, Nunez J, Levin FR, Brady KT, Nunes EV, Springer SA. Initiating Injectable Buprenorphine in People Hospitalized With Infections: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2513000. doi: 10.1001/jamanetworkopen.2025.13000.
PubMed 40445619
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coordinating Opioid Use Treatment Through Medical Management With Infection Treatment (Project COMMIT)
- ClinicalTrials.gov ID
- NCT04180020
- Acronym / sponsor ID
- COMMIT / 2000026223
- Conditions
- Opioid-use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 6 Feb 2024 (actual)
- Study completion
- 25 Apr 2024 (actual)
- First posted
- 27 Nov 2019 (actual)
- Results
- Posted 3 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Secondary Outcome measures were updated at time of results entry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAU | Active comparator | Other: TAUTreatment as Usual (TAU). |
| ID/LAB | Experimental | Other: ID/LABInfectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ID/LABID/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). | Other | ID/LAB |
| TAUTAU 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. | Other | TAU |
Primary outcome
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.
43 secondary outcomes
Days of Using Opioids
Time frame: 4 weeks
Days of Using Opioids
Time frame: From Week 4 to 8
Days of Using Opioids
Time frame: From Week 8 to 12
Days of Using Opioids
Time frame: 24 weeks
Negative Urine Screens: Opioids
Time frame: 1 week
Negative Urine Screens: Opioids
Time frame: 4 weeks
Negative Urine Screens: Opioids
Time frame: 8 weeks
Negative Urine Screens: Opioids
Time frame: 12 weeks
Negative Urine Screens: Opioids
Time frame: 24 weeks
Treatment Completion
Time frame: 12 weeks
Re-hospitalization/Emergency Room Visits
Time frame: 12 weeks
Quality of Life Measure of Social and Occupational Functioning
Time frame: 12 weeks
Quality of Life Measure of Social and Occupational Functioning
Time frame: 24 weeks
Mean Modified PEG Pain Scale Score
Time frame: 4 weeks
Mean Modified PEG Pain Scale Score
Time frame: 8 weeks
Mean Modified PEG Pain Scale Score
Time frame: 12 weeks
Mean Modified PEG Pain Scale Score
Time frame: 24 weeks
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 Sex Without a Condom in the Past 28 Days to Assess HIV Risk Behavior
Time frame: 8 Weeks
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 Sex Without a Condom 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 to Assess HIV Risk Behavior
Time frame: 4 Weeks
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 to Assess HIV Risk Behavior
Time frame: 12 Weeks
Number of Participants Who Had A Needle Sharing Activity in the Past 28 Days to Assess HIV Risk Behavior
Time frame: 24 Weeks
Treatment Satisfaction
Time frame: 12 Weeks
Treatment Satisfaction
Time frame: 24 Weeks
Unplanned Medical Discharge
Time frame: baseline
Cure of Index Infection
Time frame: 12 Weeks
Number of Participants With Hepatitis C (HCV) Detectable Viral Load
Time frame: 12 Weeks
Number of Participants With Detectable HIV Viral Load
Time frame: up to 12 Weeks
Mean Days Injecting Drugs
Time frame: 4 weeks
Mean Days Injecting Drugs
Time frame: 8 weeks
Mean Days Injecting Drugs
Time frame: 12 weeks
Mean Days Injecting Drugs
Time frame: 24 weeks
Mean Days Other Drug Use
Time frame: 4 weeks
Mean Days Other Drug Use
Time frame: 8 weeks
Mean Days Other Drug Use
Time frame: 12 weeks
Mean Days Other Drug Use
Time frame: 24 weeks
Urine Toxicology: Positive Screens
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40445619Seval N, Roth P, Frank CA, Di Paola A, Litwin AH, Vander Wyk B, Neirinckx V, Schlossberg E, Lawson P, Strong M, Schade MA, Nunez J, Levin FR, Brady KT, Nunes EV, Springer SA. Initiating Injectable Buprenorphine in People Hospitalized With Infections: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2513000. doi: 10.1001/jamanetworkopen.2025.13000.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Springer, MD principal investigator
Yale University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ID/LAB and TAU in people with Opioid-use Disorder, run by Yale University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Retention in Medication Treatment for OUD (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04180020, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.