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Young Houston Emergency Opioid Engagement System (YHEROES)

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ClinicalTrials.gov Identifier: NCT04811014
Recruitment Status : Recruiting
First Posted : March 23, 2021
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
James Langabeer, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Opioid Dependence Opioid Overdose Opioid Use Substance Use Disorders Drug: Buprenorphine, Naloxone Drug Combination Behavioral: Individual Counseling Behavioral: Peer Recovery Support Services Behavioral: Support Group Behavioral: Referral to Medication Management Behavioral: Assertive Outreach Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Houston Emergency Engagement System for Youths and Adolescents
Actual Study Start Date : April 19, 2021
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : April 1, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MOUD induction and behavioral interventions among opioid-dependent youths
Induction into medication for opioid use disorder (MOUD) treatment and behavioral interventions
Drug: Buprenorphine, Naloxone Drug Combination
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
Other Name: Suboxone

Behavioral: Individual Counseling
One-on-one counseling with a licensed chemical dependency counselor
Other Name: Therapy

Behavioral: Peer Recovery Support Services
24/7 support from our team of certified peer recovery support specialists to assist with emotional support and case management
Other Names:
  • Peer Coaching
  • Recovery Coaching

Behavioral: Support Group
Referrals to youth-focused support groups and eventual creation of in-house youth-focused support groups
Other Name: Group Therapy

Behavioral: Referral to Medication Management
Study staff will refer patients to long-term MOUD providers in the community

Behavioral: Assertive 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.
Other Name: Community Outreach




Primary Outcome Measures :
  1. Patient retention in treatment [ Time Frame: 30 days after enrollment ]
    Percentage of enrolled youth in treatment over time

  2. Patient abstinence from opioids [ Time Frame: 30 days after enrollment ]
    Days without substance use


Secondary Outcome Measures :
  1. Frequency of opioid emergencies among adolescents in Houston, Texas [ Time Frame: Through study completion, an average of 3 years ]
    Prevalence of opioid overdoses among youth



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04811014


Contacts
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Contact: James R Langabeer, PhD 713-500-3925 james.r.langabeer@uth.tmc.edu
Contact: Meredith M O'Neal, MA 713-500-3624 meredith.m.oneal@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: James R Langabeer, PhD    713-500-3925    james.r.langabeer@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: James R Langabeer, PhD The University of Texas Health Science Center, Houston
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Responsible Party: James Langabeer, Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT04811014    
Other Study ID Numbers: HSC-MS-20-1376
First Posted: March 23, 2021    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021

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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
Additional relevant MeSH terms:
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Disease
Emergencies
Substance-Related Disorders
Opioid-Related Disorders
Opiate Overdose
Pathologic Processes
Disease Attributes
Chemically-Induced Disorders
Mental Disorders
Narcotic-Related Disorders
Drug Overdose
Buprenorphine
Buprenorphine, Naloxone Drug Combination
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists