Hospital-Based Treatment for Opioid Use Disorder

Overseen By Susan L Calcaterra, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

400 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators implemented a multi-site hospital-based opioid use disorder (OUD) treatment intervention across 12 hospitals in Colorado to address an OUD treatment gap among hospitalized adults with OUD.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the drug Buprenorphine for treating opioid use disorder?

Buprenorphine is a well-established medication for treating opioid use disorder (OUD), with decades of evidence supporting its safety and effectiveness. It can be prescribed in primary care settings, and recent changes in regulations may help more doctors provide this treatment. ^{1 2 3 4 5}

Is buprenorphine safe for treating opioid use disorder in hospitals?

Research shows that starting buprenorphine treatment in hospitals is generally safe for patients with opioid use disorder, even when initiated at standard doses. ^{1 6 7 8 9}

How is the drug buprenorphine unique for treating opioid use disorder?

Buprenorphine is unique because it can be administered as a long-acting injectable, which is particularly useful in hospital settings to ensure patients receive consistent treatment and can easily transition to outpatient care after discharge. ^{1 5 10 11 12}

Research Team

Susan L Calcaterra, MD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for hospitalized adults in Colorado who are diagnosed with Opioid Use Disorder (OUD) and are experiencing a gap in treatment. Specific eligibility criteria details were not provided, so it's important to contact the study organizers for more information.

Inclusion Criteria

I am a healthcare professional working at an affiliated hospital.

Exclusion Criteria

Not applicable.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Implementation

Implementation of a multi-site hospital-based opioid use disorder treatment intervention, including nurse-driven universal screening, social work referral, and clinician education.

3 years

Follow-up

Participants are monitored for changes in prescribing rates and clinical outcomes post-intervention.

3 years

Treatment Details

Interventions

• OUD treatment intervention

Trial Overview The trial is testing an intervention designed to improve OUD treatment among hospitalized patients across 12 hospitals. It aims to address the current shortcomings in care for individuals suffering from opioid addiction.

Participant Groups

Group I: OUD intervention Experimental Treatment 1 Intervention

Participants received education on the diagnosis and management of OUD, have access to protocols to walk them through assessment of OUD using Diagnostic and Statistical Manual, fifth Edition (DSM)-5, COWS score to calculate severity of opioid withdrawal, buprenorphine or methadone initiation with pre-populated orders, and clickable links for OUD treatment referral post discharge.

OUD treatment intervention is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Suboxone for:

• Opioid dependence

Approved in United States as Suboxone for:

• Opioid dependence
• Opioid use disorder

Approved in Canada as Suboxone for:

• Opioid dependence

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

A survey of 476 residency program directors revealed that while 76.9% of residents frequently manage patients with opioid use disorder (OUD), only 23.5% of programs dedicate significant curricular time (12+ hours) to addiction medicine, and only 35.9% encourage training in office-based opioid treatment (OBOT).

Despite the majority of program directors believing that increased training in OBOT would improve access to treatment for OUD, barriers such as a lack of qualified preceptors and competing curricular priorities hinder the implementation of OBOT training in residency programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training in office-based opioid treatment with buprenorphine in US residency programs: A national survey of residency program directors. Tesema, L., Marshall, J., Hathaway, R., et al.[2019]

Over 400 clinicians participated in free buprenorphine training, but only 30 out of 101 attending physicians applied for the necessary x-waiver to prescribe it, highlighting a significant gap between training and actual prescribing.

Despite the removal of training requirements for prescribing buprenorphine, the low number of physicians who went on to prescribe it suggests that additional cultural and systemic changes are needed to improve access to treatment for opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing Access to Medications for Opioid Use Disorder in Primary Care: Removing the Training Requirement May Not Be Enough. Russell, HA., Sanders, M., Meyer, JKV., et al.[2021]

Recent case reports suggest that starting buprenorphine at low doses can effectively treat opioid use disorder (OUD) while minimizing withdrawal symptoms, which is a departure from standard higher-dose protocols.

A cohort study involving a transdermal patch as part of the treatment protocol showed good tolerance, indicating that low-dose buprenorphine initiation is a promising and feasible approach for managing OUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-Dose Initiation of Buprenorphine: A Narrative Review. Edinoff, AN., Fahmy, OH., Spillers, NJ., et al.[2023]

The study analyzed claims data from 87,877 individuals with opioid use disorder (OUD) and found that only 36.3% received medication for opioid use disorder (MOUD), highlighting a significant treatment gap, especially among women and those with mild OUD.

Overdose incidents were linked to a higher likelihood of receiving no treatment at all, indicating that urgent interventions are needed to address barriers to care in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outpatient care for opioid use disorder among the commercially insured: Use of medication and psychosocial treatment. Busch, AB., Greenfield, SF., Reif, S., et al.[2023]

Integrating evidence-based management of opioid use disorder (OUD) with patient-centered care for hospitalized patients with injection-related infections can significantly improve treatment outcomes.

Implementing strategies such as screening for OUD, initiating FDA-approved medications, and linking ID and OUD treatment post-discharge can reduce unplanned discharges and enhance adherence to antimicrobial regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond Antibiotics: A Practical Guide for the Infectious Disease Physician to Treat Opioid Use Disorder in the Setting of Associated Infectious Diseases. Seval, N., Eaton, E., Springer, SA.[2020]

Nearly 49% of patients starting buprenorphine for opioid use disorder discontinued treatment within a year, highlighting a significant challenge in managing this condition.

A machine learning framework was developed that effectively predicts which patients are at risk of discontinuing treatment, improving prediction accuracy by incorporating early medication adherence data, which could help healthcare providers tailor support for at-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A machine learning based two-stage clinical decision support system for predicting patients' discontinuation from opioid use disorder treatment: retrospective observational study. Hasan, MM., Young, GJ., Shi, J., et al.[2022]

A fellowship training program significantly increased the number of healthcare providers prescribing buprenorphine for opioid use disorder, with 84% of fellows actively prescribing by the end of the program compared to only 13% of a comparison group who completed minimal training.

The results suggest that comprehensive training beyond the basic waiver is essential for effectively addressing opioid use disorder, highlighting the importance of structured educational programs in improving treatment access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanding Access to Medications for Opioid Use Disorder Treatment Through Incentivized Continuing Education. Salisbury-Afshar, E., Smithenry, D., Boley, RA., et al.[2023]

A low threshold buprenorphine program, or Bridge Clinic, significantly reduced emergency department visits from 654 to 381 in the six months following patient referral, indicating improved management of opioid use disorder (OUD).

The program also demonstrated a high adherence rate of 56% to buprenorphine therapy at a 2-year follow-up, suggesting effective long-term treatment engagement for patients with OUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridge clinic buprenorphine program decreases emergency department visits. Sullivan, RW., Szczesniak, LM., Wojcik, SM.[2021]

Initiating buprenorphine treatment for inpatients with opioid use disorder (OUD) is generally safe, as only 5% of patients experienced moderate withdrawal symptoms after starting the medication.

However, 20% of patients reported an increase in pain scores following buprenorphine initiation, indicating that while withdrawal symptoms are minimal, pain management may need to be addressed during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of induction at standard doses of buprenorphine for inpatients with opioid use disorder. Schlechter, C., Hossain, R., Emerman, CL.[2022]

The implementation of a hospital-based protocol (IVAT) significantly increased the use of medications for opioid use disorder (MOUD) among patients with infectious complications, rising from 29% to 37% after the protocol was introduced.

Despite the increase in MOUD uptake, the overall usage remained below 50%, indicating that there are still barriers to accessing these treatments even with a structured intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Integrated Hospital Protocol for Persons With Injection-Related Infections May Increase Medications for Opioid Use Disorder Use but Challenges Remain. Eaton, EF., Lee, RA., Westfall, AO., et al.[2021]

A survey of 160 hospital-based clinicians revealed that 45% felt more ready to initiate buprenorphine treatment for opioid use disorder (OUD) compared to 34% for methadone, indicating a preference for buprenorphine in hospital settings.

Clinicians identified that enhancing education, providing addiction specialist support, and establishing clear treatment protocols could significantly improve the initiation and provision of OUD treatments in hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers to initiate buprenorphine and methadone for opioid use disorder treatment with postdischarge treatment linkage. Calcaterra, SL., Lockhart, S., Natvig, C., et al.[2023]

A randomized trial involving 200 adults with co-occurring opioid use disorder and infections is testing a new integrated care model that combines infectious disease management with long-acting buprenorphine treatment to improve outcomes.

The primary goal is to increase enrollment in effective medication treatment for opioid use disorder within 12 weeks of hospitalization, which could significantly reduce relapse rates and improve overall health in this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and methods of a multi-site randomized controlled trial of an integrated care model of long-acting injectable buprenorphine with infectious disease treatment among persons hospitalized with infections and opioid use disorder. Seval, N., Frank, CA., Litwin, AH., et al.[2022]

References

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

Training in office-based opioid treatment with buprenorphine in US residency programs: A national survey of residency program directors. [2019]

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

Increasing Access to Medications for Opioid Use Disorder in Primary Care: Removing the Training Requirement May Not Be Enough. [2021]

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

Low-Dose Initiation of Buprenorphine: A Narrative Review. [2023]

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

Outpatient care for opioid use disorder among the commercially insured: Use of medication and psychosocial treatment. [2023]

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

Beyond Antibiotics: A Practical Guide for the Infectious Disease Physician to Treat Opioid Use Disorder in the Setting of Associated Infectious Diseases. [2020]

6. England pubmed.ncbi.nlm.nih.gov

A machine learning based two-stage clinical decision support system for predicting patients' discontinuation from opioid use disorder treatment: retrospective observational study. [2022]

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

Expanding Access to Medications for Opioid Use Disorder Treatment Through Incentivized Continuing Education. [2023]

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

Bridge clinic buprenorphine program decreases emergency department visits. [2021]

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

Safety of induction at standard doses of buprenorphine for inpatients with opioid use disorder. [2022]

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

An Integrated Hospital Protocol for Persons With Injection-Related Infections May Increase Medications for Opioid Use Disorder Use but Challenges Remain. [2021]

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

Barriers to initiate buprenorphine and methadone for opioid use disorder treatment with postdischarge treatment linkage. [2023]

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

Design and methods of a multi-site randomized controlled trial of an integrated care model of long-acting injectable buprenorphine with infectious disease treatment among persons hospitalized with infections and opioid use disorder. [2022]