Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-03-08 @ 3:40 AM
Study NCT ID:
NCT06489535
Status:
RECRUITING
Last Update Posted:
2025-04-15
First Post:
2024-06-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retention and Re-Engagement in Treatment for Addiction Following Serious Injection Related Infections (RETAIN)
Sponsor:
Boston Medical Center
Organization:
Study Overview
Official Title:
Retention and Re-Engagement in Treatment for Addiction Following Serious Injection Related Infections (RETAIN): A Pilot Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RETAIN
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| K23DA054363 | NIH | None | https://reporter.nih.gov/quic… | View |