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Opioid Agonist

Comprehensive Support Program for Opioid Addiction (YHEROES Trial)

Phase 4
Recruiting
Led By James R Langabeer, 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
Patients must be able to speak English
Patients express a willingness to stop opioid use
Must not have
Be acutely psychotic, severely depressed, and in need of inpatient treatment, or is an immediate suicide risk
Be a nursing or pregnant female
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 3 years
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing a new program to help youths with opioid use disorder in Houston. The program includes medication, counseling, and peer support. The goal is to see if this program can help engage and retain more people in treatment.

Who is the study for?
This trial is for youths and adolescents in Houston who have tested positive for opioid use, are in good health overall, can speak English, consent to the study (with guardian consent if a minor), want to stop using opioids, and meet criteria for opioid dependence. It's not open to non-English speakers or those with certain medical conditions like unstable heart disease or severe mental health risks.
What is being tested?
The Young HEROES program tests an integrated approach combining assertive outreach, medication-assisted treatment (like Buprenorphine/Naloxone), counseling, and peer support. The goal is to see how well participants engage with and stick to treatments that help them overcome opioid addiction.
What are the potential side effects?
Possible side effects from the medications may include dizziness, nausea, vomiting, constipation or diarrhea. There might also be allergic reactions or withdrawal symptoms when starting buprenorphine/naloxone therapy. Emotional distress could arise from individual counseling sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can speak English.
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I am willing to stop using opioids.

Exclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Patient abstinence from opioids
Patient retention in treatment
Secondary study objectives
Frequency of opioid emergencies among adolescents in Houston, Texas

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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.

Trial Design

1Treatment groups
Experimental Treatment
Group I: MOUD induction and behavioral interventions among opioid-dependent youthsExperimental Treatment6 Interventions
Induction into medication for opioid use disorder (MOUD) treatment and behavioral interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Individual Counseling
2006
Completed Phase 3
~400
Support Group
2016
N/A
~640

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
949 Previous Clinical Trials
345,010 Total Patients Enrolled
James R Langabeer, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Media Library

Buprenorphine, Naloxone Drug Combination (Opioid Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04811014 — Phase 4
Opioid Use Disorder Research Study Groups: MOUD induction and behavioral interventions among opioid-dependent youths
Opioid Use Disorder Clinical Trial 2023: Buprenorphine, Naloxone Drug Combination Highlights & Side Effects. Trial Name: NCT04811014 — Phase 4
Buprenorphine, Naloxone Drug Combination (Opioid Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04811014 — Phase 4
~3 spots leftby Nov 2025
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