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Start Treatment and Recovery for Opioid Use Disorder

NCT ID: NCT04505540

Last Updated: 2023-12-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-30

Study Completion Date

2022-10-31

Brief Summary

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The purpose of this study is 1) to evaluate whether emergency department-initiated medically assisted treatment with Buprenorphine/Naloxone in patients presenting with opioid use disorder will produce positive outcomes at 1 week, 3 months and 6 months after treatment initiation.

Detailed Description

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The emergency department is a critical missed opportunity to engage patients with opioid use disorder in medication-assisted treatment, the most effective current treatment for the disorder. Patients presenting at the emergency department with opioid use disorder will be given the opportunity to immediately start medication assisted treatment with Naloxone/Buprenorphine then referred either to a specialized addiction bridge clinic or a local waivered provider for further treatment.

Conditions

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Opioid-use Disorder Mental Disorder Opioid Medication Assisted Treatment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Bridge Clinic

Medication assisted treatment supervised by addiction bridge clinic until stabilized in treatment.

Group Type EXPERIMENTAL

Bridge Clinic

Intervention Type OTHER

Specialized addiction bridge clinic

Interventions

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Bridge Clinic

Specialized addiction bridge clinic

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient at Emergency Department
* Diagnosis opioid use disorder according to criteria Diagnostic and Statistical Manual (DSM) 5

Exclusion Criteria

* Participating in alternate treatment program for opioid use disorder
* Prisoner
* Inability to communicate
* Psychosis
* Suicidality
* History of Buprenorphine injection
* Critical Illness
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Substance Abuse and Mental Health Services Administration (SAMHSA)

FED

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Vermont

OTHER

Sponsor Role lead

Responsible Party

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Scott Mackey

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Vermont Medical Center

Burlington, Vermont, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1R21DA049859-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CHRMS: 18-0695

Identifier Type: -

Identifier Source: org_study_id