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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 3 years
Awards & highlights

YHEROES 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.Check my eligibility
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.See study design
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.

YHEROES Trial Eligibility Criteria

Inclusion Criteria

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

YHEROES Trial 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

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

YHEROES 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
Support Group
2016
N/A
~640
Individual Counseling
2006
Completed Phase 3
~400

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
903 Previous Clinical Trials
320,962 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What mental health issues is Assertive Outreach generally deployed to address?

"Assertive Outreach is traditionally employed to alleviate opioid-related issues; yet it may also be applied in cases involving pruritus, pain, and septic shock."

Answered by AI

Does this scientific research accept test subjects of over fifty years of age?

"The requirements for entry into this clinical trial are that the patient must be within their teenage years (13 to 17). According to our research, there are 374 trials involving minors and 1206 studies with elderly participants."

Answered by AI

Has Assertive Outreach been endorsed by the FDA?

"Assertive Outreach received the highest score of 3 due to the completion of Phase 4 trials, meaning that this procedure has been approved by medical professionals."

Answered by AI

Are participants being enrolled for this investigation presently?

"According to clinicaltrials.gov, this experiment is presently searching for test subjects. The trial was initially posted on April 19th 2021 and the recent update came out of May 17th 2022."

Answered by AI

What are the criteria for eligibility in this trial?

"This trial is searching for 15 adolescents, aged 13-17, suffering from substance use disorders who are deemed by their physician to be in adequate health."

Answered by AI

Are there any prior investigations into Assertive Outreach?

"Currently, 55 active studies are exploring the effects of Assertive Outreach. Of these investigations, 13 have reached Phase 3 status and are being held at 234 different sites with a concentration in White River Junction, Vermont."

Answered by AI

What is the current number of participants joining this trial?

"Affirmative. Per the information archived on clinicaltrials.gov, participants are being sought for this study which commenced recruiting on April 19th 2021 and was last updated on May 17th 2022. The trial is accepting 15 individuals at one medical centre."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Young Houston Emergency Opioid Engagement System
James Langabeer 2021. "Young Houston Emergency Opioid Engagement System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04811014.
All > Opioid Dependence > Probuphine
~1 spots leftby Aug 2024
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