Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
250 participants
INTERVENTIONAL
2021-04-19
2030-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MOUD induction and behavioral interventions among opioid-dependent youths
Induction into medication for opioid use disorder (MOUD) treatment and behavioral interventions
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
Individual Counseling
One-on-one counseling with a licensed chemical dependency counselor
Peer Recovery Support Services
24/7 support from our team of certified peer recovery support specialists to assist with emotional support and case management
Support Group
Referrals to youth-focused support groups and eventual creation of in-house youth-focused support groups
Referral to Medication Management
Study staff will refer patients to long-term MOUD providers in the community
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.
Interventions
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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
Individual Counseling
One-on-one counseling with a licensed chemical dependency counselor
Peer Recovery Support Services
24/7 support from our team of certified peer recovery support specialists to assist with emotional support and case management
Support Group
Referrals to youth-focused support groups and eventual creation of in-house youth-focused support groups
Referral to Medication Management
Study staff will refer patients to long-term MOUD providers in the community
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
13 Years
17 Years
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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James Langabeer
Professor
Principal Investigators
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James R Langabeer, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HSC-MS-20-1376
Identifier Type: -
Identifier Source: org_study_id
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