Opioid Use DisorderRETAINNCT06489535
Retention and Re-Engagement in Treatment for Addiction Following Serious Injection Related Infections (RETAIN)
A study testing RETAIN and Unrelated videos in people with Opioid Use Disorder and Bloodstream Infection, run by Boston Medical Center at 1 site in United States.
Trial summary
This project is a pilot study of an adapted intervention of an existing Opioid Use Disorder (OUD) treatment retention intervention called Recovery Management Checkups (RMC). This intervention has been adapted to better fit the experiences and unique issues of those that have been hospitalized with serious injection… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Use Disorder, Bloodstream Infection, Osteomyelitis
- What is being tested?
- RETAIN and Unrelated videos
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2025to 11 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 and 65 years of age
- Able to provide Informed Consent
- Admitted to Boston Medical Center on any inpatient unit for an active serious injection related infection (SIRI) such as endocarditis, osteomyelitis, bacteremia, septic arthritis, epidural abscess or other serious infection in which two weeks or more of antibiotics are recommended
Who cannot join
- Not able to give informed consent
- Cognitive ability (defined through Research Assistant (RA) determination)
- Inability to complete assessments in English or Spanish (defined through RA determination).
- Unable to provide names and contact information for at least two verifiable locator persons who will know where to find them in the future.
- In police custody or expecting incarceration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retention and Re-Engagement in Treatment for Addiction Following Serious Injection Related Infections (RETAIN): A Pilot Randomized Controlled Study
This project is a pilot study of an adapted intervention of an existing Opioid Use Disorder (OUD) treatment retention intervention called Recovery Management Checkups (RMC). This intervention has been adapted to better fit the experiences and unique issues of those that have been hospitalized with serious injection related infections (SIRI) based on the findings from a prior qualitative study from the principal investigator. This project plans to test the adapted intervention within a smaller group of participants to assess feasibility, acceptability, and calculate early findings of intervention efficacy.
Hospitalizations for SIRIs are a unique entry point for patients to start their recovery journey with medications for OUD (MOUD), but many people do not remain on long-term treatment, despite evidence that indicates MOUDs reduce death and re-hospitalization after SIRIs.
Read more
The study objectives are to:
- Assess the implementation feasibility of the adapted RMC model for patients with SIRI and OUD.
- Establish preliminary estimates of intervention efficacy.
- Make further adaptions to the intervention that will reduce both known and unknown barriers to care and increase effectiveness in future larger scale trials.
Findings from this pilot study will result in further intervention refinement to better fit the target population, and serve as the basis for a larger randomized control trial that will have aims focused on more in-depth analysis of the efficacy of this program
- Conditions
- Opioid Use Disorder, Bloodstream Infection, Osteomyelitis, Endocarditis, Septic Arthritis, Epidural Abscess
- Being tested
- RETAIN, Unrelated videos
- Keywords
- Recovery Management Checkups (RMC), Serious injection related infections (SIRI), Medications for OUD (MOUD), Re-hospitalizations
- Medical subject headings
- Opioid-Related Disorders, Sepsis, Osteomyelitis, Endocarditis, Arthritis, Infectious, Epidural Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RETAINOther
There are 6 different modules that a participant in the RETAIN intervention group can be placed in: "Reinforce Antibiotic Completion", "Linkage to Antibiotic Treatment/Alternate Plan", "Reinforce Recovery", "Linkage to MOUD/Alternate Plan", "Reinforce Treatment Attendance", and "Harm Reduction Support". Participants may be assigned to no more than three modules at a time until they finish their antibiotics. After the completion of antibiotics, participants may only be in two modules. Participants' intervention can range from 15 minutes- 60 minutes depending on what modules they are placed in and how much support they feel they need. Interventions will begin at the two-week follow up after a participant has been discharged from Boston Medical Center (BMC).
Unrelated videosOther
These videos unrelated to the study topics will last approximately 30-45 minutes. Depending on the method of communication, participants will watch a video (in person) or listen to a podcast (remote)
| Study group | Role | What they receive |
|---|---|---|
| RETAIN intervention | Experimental | Participants randomized to the RETAIN intervention will receive Motivational Interviewing targeted to their clinical concerns and personalized support tailored to each participants' specific needs determined by their answers to intake questions. Receives: Other: RETAIN |
| Control | Active comparator | Control arm participants will be offered different videos or podcast episodes that are unrelated to the study topics of infections, substance use, overdose, and medication management. Receives: Other: Unrelated videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days on medications for opioid disorder (MOUD)
The timeline follow back (TLFB) method will be used to assess this outcome based on self-report.
Measured: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
Participant recruitment rates
Participant recruitment rates will be calculated by dividing the number of participants enrolled by the number of eligible patients identified.
Measured: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
Feasibility of the RETAIN Intervention based on completion of study visits
The rates of completion of study visits will be calculated by dividing the number of completed study visits by the total number of study visits.
Measured: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
Acceptability of the RETAIN Intervention
Acceptability will be assessed using the Acceptability of Intervention Measure (AIM) which is a 4-item measure of perceived intervention acceptability. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean and higher scores are associated with better acceptability.
Measured: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
Secondary outcomes (6)
Number of days of antibiotic completion
Self-report yes or no.
Measured: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
Number of days of Opioid use
The TLFB method will be used to assess this outcome based on self-report.
Measured: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
Number of Hospitalizations
The TLFB method will be used to assess this outcome based on self-report.
Measured: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
Number of uncleaned injections
Self Report based on the The Bacterial Skin Index Risk Score (BIRSI) score, which includes questions about alcohol pad and sterile water use, handwashing, rotating injection sites, injecting subcutaneously or in the muscle ("skin/muscle popping"), and clean needle use, was used as a continuous score to measure risk of skin and soft tissue infections.
Measured: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
Number of unmonitored opioid use
Self Report based on Opioid use
Measured: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
MOUD stigma
Partial adaptation of MMT-SMS stigma scale will be used to assess this outcome based on self-report
Measured: Baseline while hospitalized, and 6 month after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start6 Jan 2025
- Primary completion11 May 2026
- Study completion11 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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
- Model description
- The randomization process will involve assigning participants to either the intervention or control group The Randomization ratio will be 2:1 to intervention and will be done after enrollment by a research assistant through an automated Redcap feature.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Simeon Kimmel, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489535
- Sponsor's protocol ID
- H-44905
- Other IDs
- K23DA054363
- Acronym
- RETAIN
- Status last verified
- Jul 2026
- First submitted
- 28 Jun 2024
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retention and Re-Engagement in Treatment for Addiction Following Serious Injection Related Infections (RETAIN): A Pilot Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06489535
- Acronym / sponsor ID
- RETAIN / H-44905
- Conditions
- Opioid Use Disorder, Bloodstream Infection, Osteomyelitis, Endocarditis, Septic Arthritis, Epidural Abscess
- Keywords
- Recovery Management Checkups (RMC), Serious injection related infections (SIRI), Medications for OUD (MOUD), Re-hospitalizations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 11 May 2026 (actual)
- Study completion
- 11 May 2026 (actual)
- First posted
- 8 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project is a pilot study of an adapted intervention of an existing Opioid Use Disorder (OUD) treatment retention intervention called Recovery Management Checkups (RMC). This intervention has been adapted to better fit the experiences and unique issues of those that have been hospitalized with serious injection related infections (SIRI) based on the findings from a prior qualitative study from the principal investigator. This project plans to test the adapted intervention within a smaller group of participants to assess feasibility, acceptability, and calculate early findings of intervention efficacy.
Hospitalizations for SIRIs are a unique entry point for patients to start their recovery journey with medications for OUD (MOUD), but many people do not remain on long-term treatment, despite evidence that indicates MOUDs reduce death and re-hospitalization after SIRIs.
The study objectives are to:
- Assess the implementation feasibility of the adapted RMC model for patients with SIRI and OUD.
- Establish preliminary estimates of intervention efficacy.
- Make further adaptions to the intervention that will reduce both known and unknown barriers to care and increase effectiveness in future larger scale trials.
Findings from this pilot study will result in further intervention refinement to better fit the target population, and serve as the basis for a larger randomized control trial that will have aims focused on more in-depth analysis of the efficacy of this program
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The randomization process will involve assigning participants to either the intervention or control group The Randomization ratio will be 2:1 to intervention and will be done after enrollment by a research assistant through an automated Redcap feature.
| Arm | Type | Receives |
|---|---|---|
| RETAIN intervention | Experimental | Other: RETAINParticipants randomized to the RETAIN intervention will receive Motivational Interviewing targeted to their clinical concerns and personalized support tailored to each participants' specific needs determined by their answers to intake questions. |
| Control | Active comparator | Other: Unrelated videosControl arm participants will be offered different videos or podcast episodes that are unrelated to the study topics of infections, substance use, overdose, and medication management. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between 18 and 65 years of age
- Able to provide Informed Consent
- Admitted to Boston Medical Center on any inpatient unit for an active serious injection related infection (SIRI) such as endocarditis, osteomyelitis, bacteremia, septic arthritis, epidural abscess or other serious infection in which two weeks or more of antibiotics are recommended
Key exclusion criteria (5 listed)
- Not able to give informed consent
- Cognitive ability (defined through Research Assistant (RA) determination)
- Inability to complete assessments in English or Spanish (defined through RA determination).
- Unable to provide names and contact information for at least two verifiable locator persons who will know where to find them in the future.
- In police custody or expecting incarceration
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 |
|---|---|---|
| RETAINThere are 6 different modules that a participant in the RETAIN intervention group can be placed in: "Reinforce Antibiotic Completion", "Linkage to Antibiotic Treatment/Alternate Plan", "Reinforce Recovery", "Linkage to MOUD/Alternate Plan", "Reinforce Treatment Attendance", and "Harm Reduction Support". Participants may be assigned to no more than three modules at a time until they finish their antibiotics. After the completion of antibiotics, participants may only be in two modules. Participants' intervention can range from 15 minutes- 60 minutes depending on what modules they are placed in and how much support they feel they need. Interventions will begin at the two-week follow up after a participant has been discharged from Boston Medical Center (BMC). | Other | RETAIN intervention |
| Unrelated videosThese videos unrelated to the study topics will last approximately 30-45 minutes. Depending on the method of communication, participants will watch a video (in person) or listen to a podcast (remote) | Other | Control |
Primary outcome
Number of days on medications for opioid disorder (MOUD)
Time frame: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
The timeline follow back (TLFB) method will be used to assess this outcome based on self-report.
Participant recruitment rates
Time frame: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
Participant recruitment rates will be calculated by dividing the number of participants enrolled by the number of eligible patients identified.
Feasibility of the RETAIN Intervention based on completion of study visits
Time frame: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
The rates of completion of study visits will be calculated by dividing the number of completed study visits by the total number of study visits.
Acceptability of the RETAIN Intervention
Time frame: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
Acceptability will be assessed using the Acceptability of Intervention Measure (AIM) which is a 4-item measure of perceived intervention acceptability. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean and higher scores are associated with better acceptability.
6 secondary outcomes
Number of days of antibiotic completion
Time frame: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
Number of days of Opioid use
Time frame: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
Number of Hospitalizations
Time frame: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
Number of uncleaned injections
Time frame: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
Number of unmonitored opioid use
Time frame: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
MOUD stigma
Time frame: Baseline while hospitalized, and 6 month after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Opioid Use Disorder
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
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.
Simeon Kimmel, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RETAIN and Unrelated videos in people with Opioid Use Disorder and Bloodstream Infection, run by Boston Medical Center at 1 site 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 3 inclusion and 5 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 2 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 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 days on medications for opioid disorder (MOUD) (time frame: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2026.