Opioid Use DisorderPhase 4HEROESNCT03396276
Houston Emergency Opioid Engagement System
A Phase 4 study testing Suboxone, Brief counseling in the ED and Referral to outpatient treatment in people with Opioid Use Disorder, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Suboxone, Brief counseling in the ED and Referral to outpatient treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to 31 Aug 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In otherwise good health based on physician assessment and medical history
- Tests positive in urine sample for opioids
- Patients express a willingness to stop opioid use
- Meet Diagnostic and Statistical Manual of Mental Disorders - Text Revision (DSM-IV-TR) criteria for opioid dependence
- Patients must be able to speak English
- Be agreeable to and capable of signing informed consent
Who cannot join
- Non-English-speaking patients
- Have a known sensitivity to buprenorphine or naloxone
- Be physiologically dependent on alcohol, benzodiazepines or other drugs of abuse that require immediate medical attention. Other substance use diagnoses are not exclusionary.
- Have a medical condition that would, in the opinion of the study physician, make participation medically hazardous, including unstable cardiovascular disease, neurological deficits, trauma, acute hepatitis, stroke, and liver or renal disease)
- Be acutely psychotic, severely depressed, and in need of inpatient treatment, or is an immediate suicide risk
- Be a nursing or pregnant female
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Houston Emergency Opioid Engagement System (HEROES)
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.
Read the detailed description
The Houston Emergency Response Opioid Engagement System (HEROES) is a non-randomized cohort study based at the University of Texas Health Science Center of Houston. This study seeks to develop an emergency- initiated opioid system of care for individuals with prior opioid overdose and opioid use disorder. The study involves both assertive outreach on individuals who have recent overdoses within the last 72 hours, as well as individuals who are admitted to local hospital emergency departments. The study explores the effect of the combination of assertive outreach, same-day induction into medication-assisted treatment, ongoing maintenance treatment, behavioral counseling, peer recovery support, and paramedic follow-up on patient outcomes. The primary outcome is engagement and retention outpatient treatment. Secondary outcomes include quality of life assessment as well as subsequent relapses and overdoses. The hypothesis is that patients with earlier induction into MAT treatment in the emergency department, who receive routine follow-up, are more likely to engage and be retained in a longer-term treatment program for their addiction.
- Conditions
- Opioid Use Disorder
- Being tested
- Suboxone, Brief counseling in the ED, Referral to outpatient treatment, Follow-up coaching
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuboxoneDrug
8mg of buprenorphine/2mg of naloxone
Brief counseling in the EDBehavioural
Patients will receive brief counseling from ED physician prior to discharge about the options for outpatient treatment, as well as opioid dependency.Consented patients will be provided with a pamphlet from the Substance Abuse and Mental Health Services Administration called "Facts About Buprenorphine", as well as an information packet for study contact information for the opioid recovery network providers.
Referral to outpatient treatmentBehavioural
A referral will be made to one of the affiliated MAT clinics.
Follow-up coachingBehavioural
A designated paramedic with the Houston Fire Department (called the navigator or care coordinator) will work with UTHealth to jointly follow-up on patients both telephonically and in-person. The Houston Fire Department paramedic will provide brief information sharing and assist with coordination in scheduling or registering with MAT clinics or recovery coaching.
| Study group | Role | What they receive |
|---|---|---|
| Suboxone induction into MAT in the ED | Experimental | Suboxone induction into medication-assisted treatment (MAT) in the emergency department (ED) Receives: Drug: Suboxone; Behavioral: Brief counseling in the ED; Behavioral: Referral to outpatient treatment; Behavioral: Follow-up coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient enrollment in outpatient treatment
Measured: at the time of enrollment in outpatient treatment
Patient retention in outpatient treatment
Measured: 30 days after induction in the emergency department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start1 Apr 2018
- Primary completion31 Aug 2030 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Langabeer, The University of Texas Health Science Center, Houston
- Investigators
- James R Langabeer, EMT, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396276
- Sponsor's protocol ID
- HSC-SBMI-17-1021
- Acronym
- HEROES
- Status last verified
- Sep 2025
- First submitted
- 4 Jan 2018
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Not sharing IPD
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Houston Emergency Opioid Engagement System (HEROES)
- ClinicalTrials.gov ID
- NCT03396276
- Acronym / sponsor ID
- HEROES / HSC-SBMI-17-1021
- Conditions
- Opioid Use Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Aug 2030 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 10 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Houston Emergency Response Opioid Engagement System (HEROES) is a non-randomized cohort study based at the University of Texas Health Science Center of Houston. This study seeks to develop an emergency- initiated opioid system of care for individuals with prior opioid overdose and opioid use disorder. The study involves both assertive outreach on individuals who have recent overdoses within the last 72 hours, as well as individuals who are admitted to local hospital emergency departments. The study explores the effect of the combination of assertive outreach, same-day induction into medication-assisted treatment, ongoing maintenance treatment, behavioral counseling, peer recovery support, and paramedic follow-up on patient outcomes. The primary outcome is engagement and retention outpatient treatment. Secondary outcomes include quality of life assessment as well as subsequent relapses and overdoses. The hypothesis is that patients with earlier induction into MAT treatment in the emergency department, who receive routine follow-up, are more likely to engage and be retained in a longer-term treatment program for their addiction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suboxone induction into MAT in the ED | Experimental | Drug: Suboxone, Behavioral: Brief counseling in the ED, Behavioral: Referral to outpatient treatment, Behavioral: Follow-up coachingSuboxone induction into medication-assisted treatment (MAT) in the emergency department (ED) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- In otherwise good health based on physician assessment and medical history
- Tests positive in urine sample for opioids
- Patients express a willingness to stop opioid use
- Meet Diagnostic and Statistical Manual of Mental Disorders - Text Revision (DSM-IV-TR) criteria for opioid dependence
- Patients must be able to speak English
Key exclusion criteria (6 listed)
- Non-English-speaking patients
- Have a known sensitivity to buprenorphine or naloxone
- Be physiologically dependent on alcohol, benzodiazepines or other drugs of abuse that require immediate medical attention. Other substance use diagnoses are not exclusionary.
- Have a medical condition that would, in the opinion of the study physician, make participation medically hazardous, including unstable cardiovascular disease, neurological deficits, trauma, acute hepatitis, stroke, and liver or renal disease)
- Be acutely psychotic, severely depressed, and in need of inpatient treatment, or is an immediate suicide risk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suboxone8mg of buprenorphine/2mg of naloxone | Drug | Suboxone induction into MAT in the ED |
| Brief counseling in the EDPatients will receive brief counseling from ED physician prior to discharge about the options for outpatient treatment, as well as opioid dependency.Consented patients will be provided with a pamphlet from the Substance Abuse and Mental Health Services Administration called "Facts About Buprenorphine", as well as an information packet for study contact information for the opioid recovery network providers. | Behavioural | Suboxone induction into MAT in the ED |
| Referral to outpatient treatmentA referral will be made to one of the affiliated MAT clinics. | Behavioural | Suboxone induction into MAT in the ED |
| Follow-up coachingA designated paramedic with the Houston Fire Department (called the navigator or care coordinator) will work with UTHealth to jointly follow-up on patients both telephonically and in-person. The Houston Fire Department paramedic will provide brief information sharing and assist with coordination in scheduling or registering with MAT clinics or recovery coaching. | Behavioural | Suboxone induction into MAT in the ED |
Primary outcome
Patient enrollment in outpatient treatment
Time frame: at the time of enrollment in outpatient treatment
Patient retention in outpatient treatment
Time frame: 30 days after induction in the emergency department
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No. Not sharing IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James R Langabeer, EMT, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Suboxone, Brief counseling in the ED and Referral to outpatient treatment in people with Opioid Use Disorder, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient enrollment in outpatient treatment (time frame: at the time of enrollment in outpatient treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.