Retention and Re-Engagement in Treatment for Addiction Following Serious Injection Related Infections (RETAIN)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-06

Study Completion Date

2026-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

RETAIN: Retaining Opioid Users Entering Medication Assisted Treatment and Encouraging HCV/HIV Testing

NCT03411265

COMPLETED NA

Pilot Testing a Novel Remotely Delivered Intensive Outpatient Program for Individuals With OUD

NCT05817825

Opioid Use Disorder Serious Bacterial Infections

RECRUITING NA

Medication Adherence Therapy for Opioid Abusing Pain Patients

NCT00249587

Pain Chronic Disease Prescription Opioid Abuse

COMPLETED PHASE1/PHASE2

Comparing a Patient Self-Assessment Software to Treatment as Usual in Opioid Prescriber and Patient Opioid Outcomes

NCT04945525

Opioid-use Disorder Opioid Misuse Opioid Use +1 more

UNKNOWN NA

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

NCT04180020

Opioid-use Disorder

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Opioid Use Disorder Bloodstream Infection Osteomyelitis Endocarditis Septic Arthritis Epidural Abscess

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

RETAIN intervention

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.

Group Type EXPERIMENTAL

RETAIN

Intervention Type OTHER

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).

Control

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.

Group Type ACTIVE_COMPARATOR

Unrelated videos

Intervention Type OTHER

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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

RETAIN

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).

Intervention Type OTHER

Unrelated videos

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)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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).
* Exclusion for any reason under PI discretion
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No