High vs Low Intensity Treatment Strategies for Opioid Addiction

(EXHITENTRE Trial)

Recruiting at 3 trial locations

Overseen By Zoe Weinstein, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Hennepin Healthcare Research Institute

Disqualifiers: Existing HBOT program, Veterans Affairs, others

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

Compensation: Varies

Number of Visits: Unknown

24 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is a multi-site, cluster randomized, two group implementation trial comparing a low- versus high-intensity implementation strategy for supporting hospital-based opioid use disorder treatment (HBOT) in community hospital settings where medication for opioid use disorder (MOUD) treatment has not been implemented.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of this treatment for opioid addiction?

Research shows that methadone medical maintenance (MMM), a part of the treatment strategy, is effective in reducing the demands of opioid treatment while maintaining good outcomes. Additionally, adaptive treatment models, which adjust care based on patient needs, have been positively received by clinic staff and can improve patient participation in rehabilitation activities. ^{1 2 3 4 5}

Is the high or low intensity treatment strategy for opioid addiction safe for humans?

Buprenorphine treatment for opioid use disorder is considered safe, and methadone medical maintenance is effective without compromising safety. These treatments have been evaluated in various settings, suggesting they are generally safe for human use. ^{2 4 6 7 8}

How does injectable opioid agonist treatment (iOAT) differ from other treatments for opioid addiction?

Injectable opioid agonist treatment (iOAT) is unique because it involves administering opioids in a controlled, medical setting, which can be integrated with other health and social services to provide comprehensive care. This approach contrasts with more isolated treatments like methadone maintenance or outpatient drug-free models, offering a more person-centered and supportive environment. ^{9 10 11 12 13}

Eligibility Criteria

This trial is for community hospitals that want to start treating opioid use disorder (OUD) in hospitalized patients. Hospitals must be willing to adopt new treatment strategies, have staff trained, and work with a site champion. They should not already have an opioid treatment program or be a Veterans Affairs hospital.

Inclusion Criteria

Have hospital staff willing to engage with a site/hub team for training and data collection

I am open to any level of support during the trial.

My hospital is willing to start medication for opioid use disorder before I leave.

Exclusion Criteria

Have an ACS routinely prescribing MOUD at discharge

Be a Veterans Affairs hospital

I am part of or about to start a hyperbaric oxygen therapy program.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Community hospitals implement either a low- or high-intensity strategy for supporting hospital-based opioid use disorder treatment

24 months

Follow-up

Participants are monitored for engagement with MOUD within 34 days following hospital discharge

34 days

Long-term Follow-up

Further outcomes are assessed during the entire 4-year study period

4 years

Treatment Details

Interventions

• High Intensity
• Low Intensity

Trial Overview The study compares two methods of implementing hospital-based opioid use disorder treatments: one with low-intensity support and another with high-intensity support. It aims to see which strategy better supports the adoption of medication treatments for OUD in community hospitals.

Participant Groups

Group I: High Intensity Experimental Treatment 1 Intervention

MOUD training and support through the use of educational materials in addition to practice facilitation.

Group II: Low Intensity Active Control 1 Intervention

MOUD training and support through the use of educational materials.

Who Is Running the Clinical Trial?

Hennepin Healthcare Research Institute

Lead Sponsor

Trials

94

Recruited

77,100+

The Emmes Company, LLC

Industry Sponsor

Trials

149

Recruited

1,052,000+

Peter Ronco

The Emmes Company, LLC

Chief Executive Officer since 2023

BSc from Nottingham University

Dr. Joe Sliman

The Emmes Company, LLC

Chief Medical Officer since 2020

MD from Uniformed Services University of the Health Sciences, MPH from Johns Hopkins University, BSc in Molecular and Cell Biology from Pennsylvania State University

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

This study aims to improve the implementation of medication for opioid use disorder (MOUD) in 72 specialty addiction programs by using a tailored approach that adjusts strategies based on program needs and outcomes.

The research will evaluate the effectiveness and costs of various implementation strategies, potentially providing valuable insights for decision-makers on how to enhance MOUD delivery and address the opioid epidemic more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stepped implementation-to-target: a study protocol of an adaptive trial to expand access to addiction medications. Ford, JH., Cheng, H., Gassman, M., et al.[2022]

An intensive external facilitation intervention at eight low-adopting Veterans Health Administration facilities led to significant improvements in the uptake of medication treatment for opioid use disorder (M-OUD), with two facilities showing an increase in the percentage of patients receiving M-OUD by 8.4% and 9.9% over six months.

The study highlighted that aligning M-OUD with existing clinical practices was crucial for implementation success, indicating that addressing both barriers and facilitators can enhance the adoption of effective treatments for opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early impacts of a multi-faceted implementation strategy to increase use of medication treatments for opioid use disorder in the Veterans Health Administration. Gustavson, AM., Wisdom, JP., Kenny, ME., et al.[2021]

The BOOST Collaborative, involving 17 healthcare teams and 4301 patients with opioid use disorders, successfully implemented a quality improvement initiative over 18 months, leading to better care processes and treatment outcomes.

About 59% of the participating teams showed measurable improvements in their implementation scores, highlighting the effectiveness of structured quality improvement interventions in enhancing opioid agonist therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a regional quality improvement collaborative to improve care of people living with opioid use disorder in a Canadian setting. Beamish, L., Sagorin, Z., Stanley, C., et al.[2020]

A study involving 96 community-based treatment staff across five methadone maintenance clinics showed that a seven-session seminar on methadone medical maintenance (MMM) significantly improved staff perceptions of its benefits, including facilitating patient participation in rehabilitation activities and ensuring adequate counseling services for MMM patients.

After the seminar, one clinic adopted an adaptive stepped care model, and three out of five clinics began implementing MMM, indicating that educational interventions can effectively promote the adoption of evidence-based practices in opioid treatment programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing methadone medical maintenance in community-based clinics: disseminating evidence-based treatment. King, VL., Burke, C., Stoller, KB., et al.[2013]

A systematic review of 27 longitudinal studies on opioid treatment involving over 65,686 participants revealed significant variability in the outcome measures used, which complicates the assessment of treatment effectiveness.

The studies typically reported on less than half of the identified eight outcome domains related to drug use, health, and social functioning, indicating a need for standardized measures to improve replicability and clarity in treatment success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Large variation in measures used to assess outcomes of opioid dependence treatment: A systematic review of longitudinal observational studies. Wiessing, L., Ferri, M., Darke, S., et al.[2019]

Buprenorphine is a safe and effective treatment for opioid use disorder, but many people in need do not receive it due to strict entry requirements in treatment programs.

The concept of 'low-threshold treatment' aims to reduce barriers to access by promoting same-day treatment entry, a harm-reduction approach, flexibility, and availability in common locations for those with opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining Low-threshold Buprenorphine Treatment. Jakubowski, A., Fox, A.[2022]

The Stratification Tool for Opioid Risk Mitigation (STORM) is being used by the Veterans Health Administration to identify patients at high risk for opioid-related adverse events, aiming to improve opioid safety amidst a growing crisis.

A randomized evaluation of STORM's implementation will provide valuable insights into how mandated case reviews can affect opioid prescribing practices and potentially reduce overdose incidents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized program evaluation of the Veterans Health Administration Stratification Tool for Opioid Risk Mitigation (STORM): A research and clinical operations partnership to examine effectiveness. Minegishi, T., Frakt, AB., Garrido, MM., et al.[2021]

A study of 1244 opioid-dependent individuals found that those who stopped naltrexone treatment experienced significantly higher overdose rates (39 overdoses per 100 person-years) compared to those who left agonist treatments, indicating a critical risk period immediately after stopping naltrexone.

Overall, individuals who left any pharmacotherapy for opioid dependence had much higher rates of serious adverse events and deaths (six per 100 person-years) compared to when they were in treatment, highlighting the need for ongoing support and risk education after treatment cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious adverse events in the Australian National Evaluation of Pharmacotherapies for Opioid Dependence (NEPOD). Digiusto, E., Shakeshaft, A., Ritter, A., 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]

The study involved interviews with 14 individuals undergoing intensive outpatient treatment (IOT) for opioid use disorder (OUD), revealing that the process of connecting and disconnecting is crucial to their recovery experience.

Participants emphasized the importance of building connections with the IOT program, fellow patients, and staff, suggesting that fostering these relationships can significantly enhance engagement and support successful recovery from OUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Connecting and disconnecting: Experiences of people with opioid use disorder in intensive outpatient treatment. Keen, A., Lu, Y., Draucker, CB.[2022]

Opioid addiction treatment includes various modalities such as therapeutic communities, methadone maintenance, and outpatient drug-free models, each serving different needs of opioid users, especially those under legal obligations.

New pharmacotherapies like clonidine, LAAM, naltrexone, and buprenorphine show promise for treating opioid addiction, suggesting that treatment planning should focus more on individual needs rather than clinician biases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid addiction treatment modalities and some guidelines to their optimal use. Rawson, RA., Ling, W.[2013]

The Prescription Opioid Addiction Treatment Study (POATS) involved 10 community treatment programs across the U.S. and aimed to evaluate the effectiveness of buprenorphine/naloxone (bup/nx) in treating prescription opioid dependence, with a structured treatment design over 12 weeks.

The study compared two management strategies: Standard Medical Management (SMM) and Enhanced Medical Management (EMM), which includes individual drug counseling, to assess if EMM provides additional benefits in treating opioid dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multi-site, two-phase, Prescription Opioid Addiction Treatment Study (POATS): rationale, design, and methodology. Weiss, RD., Potter, JS., Provost, SE., et al.[2021]

Injectable opioid agonist treatment (iOAT) is effective for severe opioid use disorder and can be enhanced when integrated into comprehensive care sites that address multiple health and social needs.

The study found that incorporating iOAT in an integrated care setting fosters client autonomy and supportive relationships, which helps keep individuals engaged in their treatment and improves overall care quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"It feels like I'm coming to a friend's house": an interpretive descriptive study of an integrated care site offering iOAT (Dr. Peter Centre). Dobischok, S., Carvajal, JR., Turner, K., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Stepped implementation-to-target: a study protocol of an adaptive trial to expand access to addiction medications. [2022]

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

Early impacts of a multi-faceted implementation strategy to increase use of medication treatments for opioid use disorder in the Veterans Health Administration. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Implementation of a regional quality improvement collaborative to improve care of people living with opioid use disorder in a Canadian setting. [2020]

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

Implementing methadone medical maintenance in community-based clinics: disseminating evidence-based treatment. [2013]

5. Australia pubmed.ncbi.nlm.nih.gov

Large variation in measures used to assess outcomes of opioid dependence treatment: A systematic review of longitudinal observational studies. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Defining Low-threshold Buprenorphine Treatment. [2022]

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

Randomized program evaluation of the Veterans Health Administration Stratification Tool for Opioid Risk Mitigation (STORM): A research and clinical operations partnership to examine effectiveness. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Serious adverse events in the Australian National Evaluation of Pharmacotherapies for Opioid Dependence (NEPOD). [2022]

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

Long-term course of opioid addiction. [2015]

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

Connecting and disconnecting: Experiences of people with opioid use disorder in intensive outpatient treatment. [2022]

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

Opioid addiction treatment modalities and some guidelines to their optimal use. [2013]

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

A multi-site, two-phase, Prescription Opioid Addiction Treatment Study (POATS): rationale, design, and methodology. [2021]

13. England pubmed.ncbi.nlm.nih.gov

"It feels like I'm coming to a friend's house": an interpretive descriptive study of an integrated care site offering iOAT (Dr. Peter Centre). [2023]