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

1500 Participants Needed

Trial Summary

What is the purpose of this trial?

The Houston Emergency Response Opioid Engagement System (HEROES) is a community-based research program integrating assertive outreach, medication-assisted treatment, behavioral counseling, peer recovery support, and paramedic follow-up in Houston Texas. The objective is to compare differences in engagement and retention in treatment for individuals with opioid use disorder.

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 data supports the effectiveness of the treatment for opioid addiction?

Research shows that using buprenorphine, a key component of Suboxone, in a structured treatment program can help people with heroin addiction stay engaged in their recovery process and reduce relapse rates. Additionally, integrating care for opioid use disorder with other health services has been linked to better patient outcomes. ^{1 2 3 4 5}

Is the treatment for opioid addiction, including Suboxone, generally safe for humans?

Research shows that Suboxone, used for opioid addiction treatment, is generally safe and well-tolerated in humans. Studies indicate that serious adverse events are rare, and the safety profile is excellent, making it a practical option for diverse treatment settings. ^{6 7 8 9 10}

How is the drug Suboxone unique in treating opioid addiction?

Suboxone is unique because it combines buprenorphine, a partial opioid receptor agonist that helps reduce cravings and withdrawal symptoms, with naloxone, which deters misuse by causing withdrawal symptoms if injected. This combination allows for effective maintenance treatment in various settings, including primary care and private practice, improving access to care and reducing opioid use. ^{2 9 11 12 13}

Research Team

James R Langabeer, EMT, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

I do not speak English.

Have a known sensitivity to buprenorphine or naloxone

I am currently pregnant or nursing.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

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

The Integrating Medications for Addiction Treatment (IMAT) Index: A measure of capability at the organizational level. [2021]

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

Management of opioid use disorders among veterans in subacute rehab: Use of an interdisciplinary task force to address an emerging concern. [2018]

3. United States 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. [2015]

4. United States 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. [2023]

5. Ireland pubmed.ncbi.nlm.nih.gov

Shorter outpatient wait-times for buprenorphine are associated with linkage to care post-hospital discharge. [2023]

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

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

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

Buprenorphine in the treatment of opiate dependence. [2013]

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

Bringing buprenorphine-naloxone detoxification to community treatment providers: the NIDA Clinical Trials Network field experience. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Two-year Experience with Buprenorphine-naloxone (Suboxone) for Maintenance Treatment of Opioid Dependence Within a Private Practice Setting. [2022]

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

Implementation of required sedation assessment in nursing workflow to address naloxone utilization. [2023]

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

A transitional opioid program to engage hospitalized drug users. [2022]

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

Collaborative care of opioid-addicted patients in primary care using buprenorphine: five-year experience. [2022]

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

Primary care patient characteristics associated with completion of 6-month buprenorphine treatment. [2013]