Young Houston Emergency Opioid Engagement System (YHEROES)
Primary Purpose
Opioid-use Disorder, Opioid Dependence, Opioid Overdose
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine, Naloxone Drug Combination
Individual Counseling
Peer Recovery Support Services
Support Group
Referral to Medication Management
Assertive Outreach
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-use Disorder
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
Sites / Locations
- The University of Texas Health Science Center at HoustonRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MOUD induction and behavioral interventions among opioid-dependent youths
Arm Description
Induction into medication for opioid use disorder (MOUD) treatment and behavioral interventions
Outcomes
Primary Outcome Measures
Patient retention in treatment
Percentage of enrolled youth in treatment over time
Patient abstinence from opioids
Days without substance use
Secondary Outcome Measures
Frequency of opioid emergencies among adolescents in Houston, Texas
Prevalence of opioid overdoses among youth
Full Information
NCT ID
NCT04811014
First Posted
March 17, 2021
Last Updated
October 18, 2023
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT04811014
Brief Title
Young Houston Emergency Opioid Engagement System
Acronym
YHEROES
Official Title
Houston Emergency Engagement System for Youths and Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2021 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder, Opioid Dependence, Opioid Overdose, Opioid Use, Substance Use Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MOUD induction and behavioral interventions among opioid-dependent youths
Arm Type
Experimental
Arm Description
Induction into medication for opioid use disorder (MOUD) treatment and behavioral interventions
Intervention Type
Drug
Intervention Name(s)
Buprenorphine, Naloxone Drug Combination
Other Intervention Name(s)
Suboxone
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Individual Counseling
Other Intervention Name(s)
Therapy
Intervention Description
One-on-one counseling with a licensed chemical dependency counselor
Intervention Type
Behavioral
Intervention Name(s)
Peer Recovery Support Services
Other Intervention Name(s)
Peer Coaching, Recovery Coaching
Intervention Description
24/7 support from our team of certified peer recovery support specialists to assist with emotional support and case management
Intervention Type
Behavioral
Intervention Name(s)
Support Group
Other Intervention Name(s)
Group Therapy
Intervention Description
Referrals to youth-focused support groups and eventual creation of in-house youth-focused support groups
Intervention Type
Behavioral
Intervention Name(s)
Referral to Medication Management
Intervention Description
Study staff will refer patients to long-term MOUD providers in the community
Intervention Type
Behavioral
Intervention Name(s)
Assertive Outreach
Other Intervention Name(s)
Community Outreach
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient retention in treatment
Description
Percentage of enrolled youth in treatment over time
Time Frame
30 days after enrollment
Title
Patient abstinence from opioids
Description
Days without substance use
Time Frame
30 days after enrollment
Secondary Outcome Measure Information:
Title
Frequency of opioid emergencies among adolescents in Houston, Texas
Description
Prevalence of opioid overdoses among youth
Time Frame
Through study completion, an average of 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James R Langabeer, PhD
Phone
713-500-3925
Email
james.r.langabeer@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Meredith M O'Neal, MA
Phone
713-500-3624
Email
meredith.m.oneal@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James R Langabeer, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James R Langabeer, PhD
Phone
713-500-3925
Email
james.r.langabeer@uth.tmc.edu
12. IPD Sharing Statement
Learn more about this trial
Young Houston Emergency Opioid Engagement System
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