Recovery Management Checkups for Opioid Use Disorder

(RETAIN Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Simeon Kimmel, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Boston Medical Center

Must be taking: Mouds

Disqualifiers: Cognitive impairment, Language barrier, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on managing opioid use disorder, so it's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment RETAIN for opioid use disorder?

The research highlights that improvements in quality of life and reductions in opiate use were observed in individuals after discharge from intensive treatment programs, suggesting that ongoing assessment and support can enhance recovery outcomes. ^{1 2 3 4 5}

Is the Recovery Management Checkups for Opioid Use Disorder treatment safe for humans?

There is no specific safety data available for Recovery Management Checkups for Opioid Use Disorder or RETAIN in the provided research articles. ^{2 6 7 8 9}

How is the RETAIN treatment for opioid use disorder different from other treatments?

The RETAIN treatment is unique because it focuses on recovery management checkups, which involve regular assessments and support to help maintain recovery and prevent relapse, unlike many treatments that primarily focus on initial detoxification and stabilization. ^{1 3 8 10 11}

Research Team

Simeon Kimmel, MD

Principal Investigator

Boston Medical Center

Eligibility Criteria

The RETAIN trial is for individuals who have been hospitalized with serious injection-related infections (SIRI) like sepsis or endocarditis and also struggle with opioid use disorder. It's designed to help them stay on treatment after hospitalization.

Inclusion Criteria

Able to provide Informed Consent

I am between 18 and 65 years old.

I am admitted to Boston Medical Center for a serious infection needing 2+ weeks of antibiotics.

Exclusion Criteria

Unable to provide names and contact information for at least two verifiable locator persons who will know where to find them in the future

My thinking and memory skills are considered adequate for study participation.

Inability to complete assessments in English or Spanish (defined through RA determination)

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the RETAIN intervention, which includes Motivational Interviewing and personalized support tailored to their needs

6 months

Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

2 visits (in-person), 2 visits (virtual)

Treatment Details

Interventions

• RETAIN (Behavioural Intervention)

Trial Overview This pilot study tests an adapted intervention called Recovery Management Checkups (RMC), which aims to improve long-term treatment retention in patients recovering from SIRI and OUD. Participants will receive the RMC intervention, while its feasibility and preliminary efficacy are assessed.

Participant Groups

Group I: RETAIN intervention Experimental Treatment 1 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 II: Control Active Control 1 Intervention

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Boston Medical Center Boston, MA

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Patients Recruited

890,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2658

Patients Recruited

3,409,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outpatient follow-up and use of medications for opioid use disorder after residential treatment among Medicaid enrollees in 10 states. Cole, ES., Allen, L., Austin, A., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obstacles to treatment retention in opioid use disorder: An international substance use disorder treatment worker survey. Jones, M., Guirguis, A., Watkins, A., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life and well-being following inpatient and partial hospitalization treatment for opioid use disorder. Blevins, CE., Abrantes, AM., Kurth, ME., et al.[2019]

A pilot randomized controlled trial involving 25 hospitalized adults with opioid use disorder (OUD) tested a peer recovery coach intervention to improve retention in medications for opioid use disorder (MOUD) after discharge.

The study found no significant differences in MOUD retention rates, hospital readmissions, or time to treatment discontinuation between the recovery coach intervention group and the treatment-as-usual group, indicating that the intervention did not enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Peer Recovery Coach Intervention for Hospitalized Patients with Opioid Use Disorder: A Pilot Randomized Controlled Trial. Suzuki, J., Martin, B., Loguidice, F., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication Assisted Treatment Program Policies: Opinions of People in Treatment. Carter, M., Boyd, J., Bennett, T., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical monitoring and high-risk conditions among patients with SUD newly prescribed opioids and benzodiazepines. Grossbard, JR., Malte, CA., Saxon, AJ., et al.[2014]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine use and courses of care for opioid use disorder treatment within the Veterans Health Administration. Gordon, AJ., Saxon, AJ., Kertesz, S., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Prediction of Lapses in Opioid Use Disorder: Protocol for a Personal Sensing Study. Moshontz, H., Colmenares, AJ., Fronk, GE., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. Maricich, YA., Bickel, WK., Marsch, LA., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term course of opioid addiction. Hser, YI., Evans, E., Grella, C., et al.[2015]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term retention in Office Based Opioid Treatment with buprenorphine. Weinstein, ZM., Kim, HW., Cheng, DM., et al.[2018]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Outpatient follow-up and use of medications for opioid use disorder after residential treatment among Medicaid enrollees in 10 states. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Obstacles to treatment retention in opioid use disorder: An international substance use disorder treatment worker survey. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Quality of life and well-being following inpatient and partial hospitalization treatment for opioid use disorder. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

A Peer Recovery Coach Intervention for Hospitalized Patients with Opioid Use Disorder: A Pilot Randomized Controlled Trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Medication Assisted Treatment Program Policies: Opinions of People in Treatment. [2023]

6. Ireland pubmed.ncbi.nlm.nih.gov

Clinical monitoring and high-risk conditions among patients with SUD newly prescribed opioids and benzodiazepines. [2014]

7. Ireland pubmed.ncbi.nlm.nih.gov

Buprenorphine use and courses of care for opioid use disorder treatment within the Veterans Health Administration. [2023]

8. Canada pubmed.ncbi.nlm.nih.gov

Prospective Prediction of Lapses in Opioid Use Disorder: Protocol for a Personal Sensing Study. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Long-term course of opioid addiction. [2015]

11. United States pubmed.ncbi.nlm.nih.gov

Long-term retention in Office Based Opioid Treatment with buprenorphine. [2018]