Opioid-use DisorderPhase 4YHEROESNCT04811014
Young Houston Emergency Opioid Engagement System
A Phase 4 study testing Buprenorphine, Naloxone Drug Combination, Individual Counseling and Peer Recovery Support Services in people with Opioid-use Disorder and Opioid Dependence, 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 for Youths and Adolescents (Young HEROES) is a community-based research program integrating assertive outreach, medication for opioid use disorder (MOUD), behavioral counseling, and peer recovery support. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Opioid-use Disorder, Opioid Dependence, Opioid Overdose
- What is being tested?
- Buprenorphine, Naloxone Drug Combination, Individual Counseling and Peer Recovery Support Services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2021to 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- In otherwise good health based on physician assessment and medical history
- Drug screen positive 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 the informed consent and assent (parent or guardian must consent, minor must assent)
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, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
James R Langabeer, PhD, 713-500-3925, james.r.langabeer@uth.tmc.edu
About this study
Official title: Houston Emergency Engagement System for Youths and Adolescents
The Houston Emergency Response Opioid Engagement System for Youths and Adolescents (Young HEROES) is a community-based research program integrating assertive outreach, medication for opioid use disorder (MOUD), behavioral counseling, and peer recovery support. The objective is to compare differences in engagement and retention in treatment for individuals with opioid use disorder. The investigators also intend to understand the prevalence of opioid overdoses and OUD among youth in Houston.
Read the detailed description
The Houston Emergency Response Opioid Engagement System for Youths and Adolescents (Young HEROES) is a non-randomized cohort study based at the University of Texas Health Science Center of Houston. This study recruits participants through three avenues: assertive community outreach with a peer coach and paramedic following and opioid overdose, community referrals, and emergency department referrals. The study explores the effect of the combination of assertive outreach, same-day induction into medication for opioid use disorder, ongoing maintenance treatment, behavioral counseling, peer recovery support, and paramedic follow-up on patient outcomes. The primary outcome is engagement and retention in 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 MOUD treatment who receive routine follow-up, are more likely to engage and remain in treatment long-term.
- Conditions
- Opioid-use Disorder, Opioid Dependence, Opioid Overdose, Opioid Use, Substance Use Disorders
- Being tested
- Buprenorphine, Naloxone Drug Combination, Individual Counseling, Peer Recovery Support Services, Support Group, Referral to Medication Management
- Medical subject headings
- Opioid-Related Disorders, Opiate Overdose, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buprenorphine, Naloxone Drug CombinationDrug
Also called Suboxone
8mg of buprenorphine/2mg of naloxone to initiate MOUD treatment and bridge, if necessary, until referral to MOUD clinic can be made for ongoing treatment
Individual CounselingBehavioural
Also called Therapy
One-on-one counseling with a licensed chemical dependency counselor
Peer Recovery Support ServicesBehavioural
Also called Peer Coaching, Recovery Coaching
24/7 support from our team of certified peer recovery support specialists to assist with emotional support and case management
Support GroupBehavioural
Also called Group Therapy
Referrals to youth-focused support groups and eventual creation of in-house youth-focused support groups
Referral to Medication ManagementBehavioural
Study staff will refer patients to long-term MOUD providers in the community
Assertive OutreachBehavioural
Also called Community Outreach
The investigators will conduct weekly outreach to youths who experienced an opioid overdose and attempt to initiate treatment. Outreach is completed by a paramedic and peer coach.
| Study group | Role | What they receive |
|---|---|---|
| MOUD induction and behavioral interventions among opioid-dependent youths | Experimental | Induction into medication for opioid use disorder (MOUD) treatment and behavioral interventions Receives: Drug: Buprenorphine, Naloxone Drug Combination; Behavioral: Individual Counseling; Behavioral: Peer Recovery Support Services; Behavioral: Support Group; Behavioral: Referral to Medication Management; Behavioral: Assertive Outreach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient retention in treatment
Percentage of enrolled youth in treatment over time
Measured: 30 days after enrollment
Patient abstinence from opioids
Days without substance use
Measured: 30 days after enrollment
Secondary outcomes (1)
Frequency of opioid emergencies among adolescents in Houston, Texas
Prevalence of opioid overdoses among youth
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start19 Apr 2021
- 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
- 250 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, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811014
- Sponsor's protocol ID
- HSC-MS-20-1376
- Acronym
- YHEROES
- Status last verified
- Sep 2025
- First submitted
- 17 Mar 2021
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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 Engagement System for Youths and Adolescents
- ClinicalTrials.gov ID
- NCT04811014
- Acronym / sponsor ID
- YHEROES / HSC-MS-20-1376
- Conditions
- Opioid-use Disorder, Opioid Dependence, Opioid Overdose, Opioid Use, Substance Use Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 31 Aug 2030 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 23 Mar 2021 (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 for Youths and Adolescents (Young HEROES) is a community-based research program integrating assertive outreach, medication for opioid use disorder (MOUD), behavioral counseling, and peer recovery support. The objective is to compare differences in engagement and retention in treatment for individuals with opioid use disorder. The investigators also intend to understand the prevalence of opioid overdoses and OUD among youth in Houston.
Detailed description
The Houston Emergency Response Opioid Engagement System for Youths and Adolescents (Young HEROES) is a non-randomized cohort study based at the University of Texas Health Science Center of Houston. This study recruits participants through three avenues: assertive community outreach with a peer coach and paramedic following and opioid overdose, community referrals, and emergency department referrals. The study explores the effect of the combination of assertive outreach, same-day induction into medication for opioid use disorder, ongoing maintenance treatment, behavioral counseling, peer recovery support, and paramedic follow-up on patient outcomes. The primary outcome is engagement and retention in 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 MOUD treatment who receive routine follow-up, are more likely to engage and remain in treatment long-term.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MOUD induction and behavioral interventions among opioid-dependent youths | Experimental | Drug: Buprenorphine, Naloxone Drug Combination, Behavioral: Individual Counseling, Behavioral: Peer Recovery Support Services, Behavioral: Support Group, Behavioral: Referral to Medication Management, Behavioral: Assertive OutreachInduction into medication for opioid use disorder (MOUD) treatment and behavioral interventions |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- In otherwise good health based on physician assessment and medical history
- Drug screen positive 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 |
|---|---|---|
| Buprenorphine, Naloxone Drug CombinationAlso: Suboxone8mg of buprenorphine/2mg of naloxone to initiate MOUD treatment and bridge, if necessary, until referral to MOUD clinic can be made for ongoing treatment | Drug | MOUD induction and behavioral interventions among opioid-dependent youths |
| Individual CounselingAlso: TherapyOne-on-one counseling with a licensed chemical dependency counselor | Behavioural | MOUD induction and behavioral interventions among opioid-dependent youths |
| Peer Recovery Support ServicesAlso: Peer Coaching, Recovery Coaching24/7 support from our team of certified peer recovery support specialists to assist with emotional support and case management | Behavioural | MOUD induction and behavioral interventions among opioid-dependent youths |
| Support GroupAlso: Group TherapyReferrals to youth-focused support groups and eventual creation of in-house youth-focused support groups | Behavioural | MOUD induction and behavioral interventions among opioid-dependent youths |
| Referral to Medication ManagementStudy staff will refer patients to long-term MOUD providers in the community | Behavioural | MOUD induction and behavioral interventions among opioid-dependent youths |
| Assertive OutreachAlso: Community OutreachThe investigators will conduct weekly outreach to youths who experienced an opioid overdose and attempt to initiate treatment. Outreach is completed by a paramedic and peer coach. | Behavioural | MOUD induction and behavioral interventions among opioid-dependent youths |
Primary outcome
Patient retention in treatment
Time frame: 30 days after enrollment
Percentage of enrolled youth in treatment over time
Patient abstinence from opioids
Time frame: 30 days after enrollment
Days without substance use
1 secondary outcome
Frequency of opioid emergencies among adolescents in Houston, Texas
Time frame: Through study completion, an average of 3 years
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.
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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, 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 Buprenorphine, Naloxone Drug Combination, Individual Counseling and Peer Recovery Support Services in people with Opioid-use Disorder and Opioid Dependence, 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: looking for participants now, 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?
Contact James R Langabeer, PhD (713-500-3925, james.r.langabeer@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient retention in treatment (time frame: 30 days after enrollment). 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.