Recovery Management Checkups for Opioid Use Disorder

(RETAIN Trial)

Overseen By Simeon Kimmel, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Medical Center

Must be taking: Mouds

Disqualifiers: Cognitive impairment, Language barrier, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 6 months

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help people continue their medication for opioid use disorder (OUD) after treatment for serious infections related to injection drug use. The researchers aim to determine if an adapted intervention, called RETAIN (a personalized support program), can help participants adhere to their treatment plan and reduce the risk of future illness. Participants will either receive personalized support tailored to their needs or engage with unrelated content like podcasts. Suitable candidates have been admitted to Boston Medical Center with a serious injection-related infection, such as endocarditis or osteomyelitis, and require at least two weeks of antibiotics. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance support for OUD patients.

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 prior data suggests that this intervention is safe for patients with SIRI and OUD?

Research shows that treatments for opioid use disorder (OUD) are generally safe and can help people improve their lives. Studies have found that programs supporting people in OUD treatment often achieve high retention rates, meaning participants tend to stick with the treatment and reduce their use of illegal drugs.

The RETAIN program employs motivational interviewing, a conversational technique that helps individuals find their own reasons to change and remain in treatment. Although specific safety data for RETAIN might not be available, the methods it uses are well-regarded and have been safely used in other programs.

The current trial is in the "Not Applicable" phase, indicating it is early in testing but shows promise for being safe and helpful based on past methods. This phase often evaluates how practical and acceptable a treatment is, rather than just its safety. So far, treatments like RETAIN have been safe and well-tolerated in similar settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for opioid use disorder, which often involve medications like methadone or buprenorphine, the RETAIN intervention is unique because it focuses on personalized support through Motivational Interviewing. Researchers are excited about this approach because it tailors support to each individual's specific needs, identified through their personal intake responses, rather than relying solely on medication. This personalized, conversational technique aims to directly address clinical concerns and could enhance motivation for recovery in a way that standard medication treatments might not.

What evidence suggests that the RETAIN intervention could be effective for Opioid Use Disorder?

Research has shown that medications for opioid use disorder (MOUD) can reduce deaths and hospital visits after serious infections from drug use. However, many people stop taking these medications within a year, leading to worse health outcomes. Studies have found that long-term use of MOUD results in better health. In this trial, participants in the RETAIN intervention arm will receive personalized support and motivational talks to help them continue their medication. This approach aims to address personal challenges, making it easier for individuals to adhere to their treatment and enhance their recovery journey. ^{6 7 8 9 10}

Who Is on the Research Team?

Simeon Kimmel, MD

Principal Investigator

Boston Medical Center

Are You a Good Fit for This Trial?

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

Exclusion Criteria

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

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

Exclusion for any reason under PI discretion

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• RETAIN

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.

How Is the Trial Designed?

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.

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

A study involving 143 participants in opioid treatment programs showed significant improvements in quality of life and reductions in opiate use one month after discharge, indicating positive outcomes from treatment.

Greater improvements in specific health domains (Health, Substance Use, and Emotional Health) were linked to lower relapse rates, suggesting that focusing on these areas can enhance post-treatment success.

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 significant majority of patients with substance use disorders (SUD) prescribed opioids (67% for opioids only and 94% for concurrent opioids and benzodiazepines) had at least one psychiatric diagnosis, highlighting the need for careful monitoring in this high-risk population.

Despite high rates of psychiatric comorbidity, only a small percentage of patients engaged in mental health or SUD specialty care (30% for opioids only and 48% for concurrent medications), indicating a gap in necessary clinical monitoring and support for these patients.

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]

In a study of 1237 patients receiving buprenorphine for opioid use disorder, over half (53.7%) were retained in treatment for at least one year, indicating that long-term retention is achievable in an Office Based Opioid Treatment program.

Factors such as being female, having a psychiatric diagnosis, and older age were associated with higher retention rates, while unemployment, having hepatitis C, and being from certain racial/ethnic backgrounds were linked to lower retention, highlighting significant disparities in treatment outcomes.

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]

In a study of 255,726 Veterans with opioid use disorder (OUD), 15.8% received buprenorphine medication treatment (B-MOUD), with a significant increase in treatment courses over time, from 1550 in 2007 to 8146 in 2018.

Patients receiving B-MOUD had a median treatment duration of 157 days, with 33.8% undergoing multiple treatment courses, indicating that B-MOUD is a commonly utilized and persistent treatment option for managing OUD in this population.

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]

A survey of 497 substance use disorder treatment workers in the USA and UK revealed that personality disorders, low motivation to change, and social problems are the primary barriers to treatment retention for individuals with opioid use disorder (OUD).

The study highlighted regional differences in treatment approaches, with UK providers favoring behavioral treatments, while US providers more frequently utilized objective measures like urine analysis to assess retention, indicating a need for tailored training for treatment staff.

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]

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]

A study involving 225 participants from medication-assisted treatment (MAT) programs in West Virginia highlighted that most individuals currently in MAT prefer personalized treatment plans and shared decision-making with their healthcare providers.

Participants expressed mixed opinions on policies regarding the duration of MAT, use of marijuana or anti-anxiety medications during treatment, and attendance in peer recovery groups, indicating the need for flexible and individualized approaches to support retention in MAT.

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]

A new study is developing a lapse risk prediction model for individuals recovering from opioid use disorder (OUD), involving 480 participants in their first year of recovery who will use a smartphone app to report lapses and provide data on risk factors.

The model aims to enhance long-term recovery by enabling timely interventions through digital therapeutics, adapting to the changing risk of relapse over time.

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]

Opioid addiction is a chronic disorder characterized by high relapse rates, with long-term studies showing that less than 30% of individuals achieve stable abstinence after 10-30 years, and overdose is the leading cause of increased mortality (6 to 20 times higher than the general population).

Factors such as longer treatment retention, family and social support, and stable employment significantly enhance recovery chances, while histories of abuse and comorbid mental disorders hinder progress; recent pharmacological treatments like buprenorphine and naltrexone show promise, but their long-term effects are still being evaluated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

A significant portion of patients with opioid use disorder (OUD) do not receive follow-up care after residential treatment, with 62.5% lacking follow-up at 7 days and 46.9% at 30 days post-discharge, indicating a gap in best practice support.

Factors such as co-occurring mental health conditions, longer treatment stays, previous use of medications for OUD, and recent emergency department visits are linked to higher rates of follow-up and medication use after discharge, suggesting areas for targeted interventions.

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]

In a study of 170 adults with opioid use disorder, those receiving a digital therapeutic alongside standard treatment had significantly higher rates of opioid abstinence (77.3% vs. 62.1%) during the final weeks of treatment.

The digital therapeutic also improved treatment retention, with participants less likely to leave treatment compared to those receiving standard care alone, while showing no increase in adverse events, indicating it is a safe and effective addition to traditional therapies.

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]

Citations

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Using Data Science to Improve Outcomes for Persons with ... Even if patients receive MOUD, 40%-55% of persons discontinue MOUD within a year after initiation, and recent data show a six-fold increase in mortality in the ...

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Treatment for Opioid Use Disorder: Population Estimates In 2022, 3.7% of US adults aged ≥18 years needed OUD treatment. Among these, only 25.1% received medications for OUD.

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4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0955395922002298

Peer recovery specialist-delivered, behavioral activation ... For effectiveness outcomes, 88.6% of participants in Peer Activate were retained in methadone treatment at three-months post-intervention—28.9% higher than ...

5. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK541393/

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Three-month outcomes from a patient-centered program to ... This study shows that people with OUD can achieve a high treatment retention rate, cut down their use of illicit drugs, and build their recovery ...

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Using data science to improve outcomes for persons with ... Nearly 500,000 people have died of an opioid overdose between 1999 and 2019, and initial estimates from 2020 suggest a 30% increase in overdose ...

9. cdc.gov cdc.gov/overdose-prevention/prevention/preventing-opioid-use-disorder.html

Preventing Opioid Use Disorder | Overdose Prevention Treatment may save a life and can help people struggling with opioid addiction get their lives back on track by allowing them to counteract ...

10. pew.org pew.org/en/research-and-analysis/issue-briefs/2022/10/states-should-measure-opioid-use-disorder-treatment-to-improve-outcomes

States Should Measure Opioid Use Disorder Treatment to ... Studies have shown that long-term treatment can lead to better outcomes in employment, health, and criminal justice involvement.28 In addition, ...