NCT04811014 Young Houston Emergency Opioid Engagement System
| NCT ID | NCT04811014 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | The University of Texas Health Science Center, Houston |
| Condition | Opioid-use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2021-04-19 |
| Primary Completion | 2030-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 250 participants in total. It began in 2021-04-19 with a primary completion date of 2030-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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
Contact & Investigator
James R Langabeer, PhD
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center, Houston
Frequently Asked Questions
Who can join the NCT04811014 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 17 Years, studying Opioid-use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04811014 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04811014 currently recruiting?
Yes, NCT04811014 is actively recruiting participants. Contact the research team at james.r.langabeer@uth.tmc.edu for enrollment information.
Where is the NCT04811014 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT04811014 clinical trial?
NCT04811014 is sponsored by The University of Texas Health Science Center, Houston. The principal investigator is James R Langabeer, PhD at The University of Texas Health Science Center, Houston. The trial plans to enroll 250 participants.