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Opioid Agonist

Integrated Opioid Addiction Care for Opioid Addiction (HEROES Trial)

Phase 4
Waitlist Available
Led By James R Langabeer, EMT, PhD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Non-English-speaking patients
Be a nursing or pregnant female
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial is testing a new approach to treating opioid addiction that integrates different types of care and follow-up.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Suboxone may cause side effects such as nausea, vomiting, drug withdrawal syndrome, headache, sweating, numb mouth feeling due to naloxone when injected intravenously instead of taken by mouth as prescribed.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not speak English.
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I am currently pregnant or nursing.
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I am not severely depressed, acutely psychotic, or at immediate risk of suicide.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Suboxone induction into MAT in the EDExperimental Treatment4 Interventions
Suboxone induction into medication-assisted treatment (MAT) in the emergency department (ED)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Suboxone
2008
Completed Phase 3
~290

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
957 Previous Clinical Trials
346,357 Total Patients Enrolled
James R Langabeer, EMT, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Media Library

Suboxone (Opioid Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03396276 — Phase 4
Opioid Use Disorder Research Study Groups: Suboxone induction into MAT in the ED
Opioid Use Disorder Clinical Trial 2023: Suboxone Highlights & Side Effects. Trial Name: NCT03396276 — Phase 4
Suboxone (Opioid Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03396276 — Phase 4
Opioid Use Disorder Patient Testimony for trial: Trial Name: NCT03396276 — Phase 4
~136 spots leftby Aug 2025
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