Integrated Opioid Addiction Care for Opioid Addiction

(HEROES Trial)

Overseen By James R Langabeer, EMT, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: The University of Texas Health Science Center, Houston

Must not be taking: Alcohol, Benzodiazepines, others

Disqualifiers: Non-English, Unstable cardiovascular, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to keep people engaged in treatment for opioid addiction. It focuses on using Suboxone, a medication that helps manage withdrawal symptoms, as part of a larger support system that includes counseling and peer support. Participants begin this treatment in the emergency department. Individuals who have tested positive for opioids, wish to stop using them, and are in generally good health might be a good fit for this trial. As a Phase 4 trial, this research seeks to understand how this already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are dependent on alcohol, benzodiazepines, or other drugs that need immediate medical attention, you may not be eligible to participate.

What is the safety track record for these treatments?

Research has shown that Suboxone, a combination of buprenorphine and naloxone, is generally safe for individuals with opioid use disorder. The FDA has approved Suboxone for treating opioid dependence, indicating it has passed strict safety tests.

Studies have found that buprenorphine, a component of Suboxone, helps reduce cravings and withdrawal symptoms from opioids. It partially activates the same brain areas as opioids but does not cause a high, making it safer and less likely to be misused.

Common side effects of Suboxone include nausea, headache, and sweating, but these are usually mild and manageable. Rarely, some individuals might experience dizziness or drowsiness. Discussing any concerns with a healthcare provider is important.

Overall, Suboxone is considered a safe option for treating opioid addiction, and ongoing research continues to evaluate its safety in different situations. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Suboxone induction in the emergency department (ED) because it offers a new way to quickly initiate medication-assisted treatment (MAT) for opioid addiction. Unlike typical approaches that might involve referrals and delayed treatment starts, this method allows patients to begin their recovery journey right in the ED, potentially reducing drop-out rates and enhancing immediate access to care. Suboxone combines buprenorphine and naloxone, effectively managing withdrawal symptoms and cravings, which could improve patient outcomes and reduce the risk of overdose.

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

Research has shown that Suboxone, a combination of buprenorphine and naloxone, effectively treats opioid addiction. Studies have found that it significantly lowers the risk of death and helps individuals remain drug-free. For instance, those taking Suboxone had a 36% lower chance of experiencing an opioid overdose. This treatment also reduces the overall risk of death related to opioid use. Suboxone is a proven option for managing opioid addiction successfully. Participants in this trial will receive Suboxone induction into medication-assisted treatment (MAT) in the emergency department (ED). ^{2 6 7 8 9}

Who Is on the Research Team?

James R Langabeer, EMT, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for individuals who have tested positive for opioid use, can communicate in English, are willing to quit opioids, and meet the criteria for opioid dependence. They must be in good health overall and able to consent to the study. Pregnant or nursing women, those with severe other drug dependencies needing immediate treatment, or serious medical conditions like unstable heart disease are excluded.

Inclusion Criteria

I am willing to stop using opioids.

Tests positive in urine sample for opioids

Meet Diagnostic and Statistical Manual of Mental Disorders - Text Revision (DSM-IV-TR) criteria for opioid dependence

Exclusion Criteria

Have a known sensitivity to buprenorphine or naloxone

I am currently pregnant or nursing.

I am not severely depressed, acutely psychotic, or at immediate risk of suicide.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive assertive outreach, same-day induction into medication-assisted treatment, ongoing maintenance treatment, behavioral counseling, and peer recovery support

12 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for engagement and retention in outpatient treatment, quality of life, and subsequent relapses and overdoses

4 weeks

Bi-weekly visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Brief counseling in the ED
• Follow-up coaching
• Referral to outpatient treatment
• Suboxone

Trial Overview The HEROES program aims to help people with opioid addiction by combining medication-assisted treatment (Suboxone), counseling right after an emergency visit, outpatient referrals, coaching support from peers who've recovered from addiction themselves, and follow-up care from paramedics.

How Is the Trial Designed?

Group I: Suboxone induction into MAT in the ED Experimental Treatment 4 Interventions

Suboxone induction into medication-assisted treatment (MAT) in the emergency department (ED)

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

Buprenorphine is as effective as methadone for opiate detoxification and maintenance but is safer in overdose situations, making it a preferable option for treatment.

Suboxone, a combination of buprenorphine and naloxone, is recommended for maintenance treatment due to its lower abuse potential, while Subutex (buprenorphine alone) is advised for pregnant women, highlighting the tailored approach to treatment based on patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine in the treatment of opiate dependence. Wesson, DR., Smith, DE.[2013]

Buprenorphine-naloxone (Suboxone) was found to be safe and well tolerated for short-term opioid detoxification in a study involving 234 opioid-dependent patients across twelve community-based treatment programs.

The treatment showed high medication compliance (81% of doses ingested) and successful induction, with 90% of patients reaching the target dose within three days, indicating its efficacy and practicality in diverse settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bringing buprenorphine-naloxone detoxification to community treatment providers: the NIDA Clinical Trials Network field experience. Amass, L., Ling, W., Freese, TE., et al.[2022]

The pilot buprenorphine treatment program (BTP) showed significant improvements in treatment engagement for detoxified heroin users, with increased referrals to intensive inpatient programs and higher completion rates of outpatient treatment.

Participants who completed the BTP reported greater challenges in achieving abstinence but were less likely to use cocaine or alcohol and had lower relapse rates, suggesting that buprenorphine may enhance the effectiveness of post-detoxification care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine from detox and beyond: preliminary evaluation of a pilot program to increase heroin dependent individuals' engagement in a full continuum of care. Donovan, DM., Knox, PC., Skytta, JA., et al.[2015]

A qualitative study involving 22 patients, 24 clinical staff, and 5 clinic leaders identified key themes for improving the integration of HIV and opioid use disorder (OUD) care, emphasizing the need to address social risks and knowledge gaps about treatments.

The development of a new measurement tool based on these insights aims to enhance service delivery for patients with HIV and OUD by focusing on patient-centered policies and effective communication between organizations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"No more falling through the cracks": A qualitative study to inform measurement of integration of care of HIV and opioid use disorder. Oldfield, BJ., Muñoz, N., Boshnack, N., et al.[2023]

In a study of 46,952 hospital patients, 158 received naloxone due to opioid-related issues, highlighting the ongoing risk of opioid oversedation in hospitalized patients.

The study suggests that implementing better sedation assessments and coordinated pain management strategies could help prevent the need for naloxone by reducing the reliance on opioids and minimizing the use of multiple sedating medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of required sedation assessment in nursing workflow to address naloxone utilization. Hardison, E., Bloomer, A., Wally, MK., et al.[2023]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11610725/

Buprenorphine-Naloxone for Opioid Use Disorder Buprenorphine-naloxone was associated with significantly reduced mortality and increased remission rates for patients with opioid use disorder.

2. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7325a1.htm

Treatment for Opioid Use Disorder: Population Estimates Medications for opioid use disorder (OUD), particularly buprenorphine and methadone, substantially reduce overdose-related and overall mortality ...

3. 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).

4. mdpi.com mdpi.com/2813-0618/1/3/10

Evaluation of the Effectiveness of Buprenorphine-Naloxone ... Their results demonstrated that an additional 100-day buprenorphine treatment was associated with a 36% reduction in risk of opioid overdose ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2949875923002606

Evaluation of opioid use disorder treatment outcomes in ... In this study, patients receiving once daily buprenorphine-naloxone had similar treatment outcomes to patients receiving split dosing.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK459126/

Buprenorphine - StatPearls - NCBI Bookshelf Buprenorphine is approved by the U.S. Food and Drug Administration (FDA) to treat acute and chronic pain and opioid dependence. This drug is used in agonist ...

7. health.ny.gov health.ny.gov/publications/0111.pdf

Buprenorphine for Opioid Use Disorder 35. FDA Drug Safety Communication: FDA urges caution about withholding opioid addiction medications from patients taking benzodiazepines or CNS depressants: ...

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

What is Buprenorphine? Side Effects, Treatment & Use Buprenorphine is the first medication to treat opioid use disorder (OUD) that can be prescribed or dispensed in physician offices, significantly increasing ...

9. acog.org acog.org/clinical/clinical-guidance/committee-opinion/articles/2017/08/opioid-use-and-opioid-use-disorder-in-pregnancy

Opioid Use and Opioid Use Disorder in Pregnancy Recent evidence supports the use of buprenorphine for opioid use disorder treatment during pregnancy. Buprenorphine acts on the same mu-opioid receptors as ...