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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new hospital-based approach to assist individuals with opioid use disorder (OUD) who are currently hospitalized. The goal is to enhance access to treatment by providing education and resources, such as buprenorphine or methadone, to manage withdrawal symptoms. Individuals diagnosed with OUD and currently hospitalized in Colorado may be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches in OUD treatment.

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 prior data suggests that this OUD treatment intervention is safe?

Research has shown that buprenorphine is safe and effective for treating opioid addiction. Studies have found that doses over 16 mg are effective and do not cause major problems in emergency situations. When taken as directed, buprenorphine reduces cravings and withdrawal symptoms.

Methadone is another treatment option that has been used successfully for many years to manage opioid addiction. It eases withdrawal symptoms and cravings, allowing people to stay in treatment longer.

Both buprenorphine and methadone have been extensively studied and are known to be safe when used correctly. They support individuals with opioid addiction in starting and adhering to their recovery plans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it offers a comprehensive approach to treating opioid use disorder (OUD) directly within the hospital setting. Unlike standard treatments that typically focus on medication alone, this intervention includes education on OUD management, tools for assessing withdrawal severity, and standardized plans to start medications like buprenorphine or methadone. It also provides an organized pathway for referral to continued care after hospital discharge, potentially improving long-term recovery outcomes. This holistic and structured approach aims to streamline and enhance the continuity of OUD treatment from hospital to home, addressing gaps in current care models.

What evidence suggests that this trial's treatments could be effective for opioid use disorder?

In this trial, participants will receive an intervention for opioid use disorder (OUD) that includes education on its diagnosis and management, along with access to protocols for assessing OUD severity and starting treatment with either buprenorphine or methadone. Studies have shown that both buprenorphine and methadone effectively reduce cravings and withdrawal symptoms. Since 2002, buprenorphine has helped individuals with opioid addiction. Research indicates that these medications result in fewer overdoses and health issues related to opioids compared to other treatments. Methadone and buprenorphine stabilize brain function and reduce the need for illegal opioids. With these treatments, patients are more likely to fully recover from opioid use disorder. ^{5 6 7 8 9}

Who Is on the Research Team?

Susan L Calcaterra, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6585403/

Buprenorphine Treatment for Opioid Use Disorder Methadone was studied in order to find a medication to: 1) Prevent opiate withdrawal, 2) Reduce “drug hunger” or craving, and 3) Normalize physiologic functions ...

2. samhsa.gov samhsa.gov/

Home | SAMHSA - Substance Abuse and Mental Health ... SAMHSA leads efforts to advance behavioral health across the U.S., offering resources for mental health, substance use, and community well-being.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2760032

Comparative Effectiveness of Different Treatment Pathways ... Meaning Methadone and buprenorphine were associated with reduced overdose and opioid-related morbidity compared with opioid antagonist therapy, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2772724623000033

History of the discovery, development, and FDA-approval ... Buprenorphine-based medications were first approved by the United States Food and Drug Administration in 2002 for the treatment of opioid dependence.

5. aafp.org aafp.org/pubs/afp/issues/2019/1001/p416.html

Opioid Use Disorder: Medical Treatment Options With appropriate medication-assisted treatment, patients are more likely to enter full recovery. Methadone and buprenorphine are opioid agonists ...

6. nih.gov nih.gov/news-events/news-releases/higher-doses-buprenorphine-may-improve-treatment-outcomes-people-opioid-use-disorder

Higher doses of buprenorphine may improve treatment ... Studies have shown that more than 16 mg of buprenorphine is safe and well tolerated in people with opioid use disorder in emergency department ...

7. samhsa.gov samhsa.gov/substance-use/treatment/options/buprenorphine

What is Buprenorphine? Side Effects, Treatment & Use When taken as prescribed, buprenorphine is safe and effective. Buprenorphine has unique pharmacological properties that: Diminish the effects of ...

8. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2825088

Buprenorphine/Naloxone vs Methadone for the Treatment ... The risk of treatment discontinuation was higher among recipients of buprenorphine/naloxone compared with methadone (88.8% vs 81.5% within 24 months).

9. sciencedirect.com sciencedirect.com/science/article/pii/S2949875923002060

Integrated analysis of phase 3 studies Extending BUP-XR treatment beyond 6 months sustained improvement in opioid abstinence and was well tolerated, supporting clinical benefit up to 18 months.