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

NCT06489535 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-13

No results posted yet for this study

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 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

Conditions

  • Opioid Use Disorder
  • Bloodstream Infection
  • Osteomyelitis
  • Endocarditis
  • Septic Arthritis
  • Epidural Abscess

Interventions

OTHER

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).

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)

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH
  • Boston Medical Center

    lead OTHER

Principal Investigators

  • Simeon Kimmel, MD · Boston Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-06
Primary Completion
2026-05-11
Completion
2026-05-11

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06489535 on ClinicalTrials.gov