Start Treatment and Recovery for Opioid Use Disorder

Not Applicable

Completed

• Conditions: Opioid-use Disorder; Opioid Medication Assisted Treatment; Mental Disorder
• Interventions: Other: Bridge Clinic

• Registration Number: NCT04505540
• Lead Sponsor: University of Vermont

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-09-30
• Study First Submitted: 2020-06-11
• Study First Submitted QC: 2020-08-05
• Study First Posted: 2020-08-10
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Results First Submitted: 2023-11-01
• Status Verified: 2023-12
• Results First Submitted QC: 2023-12-08
• Last Update Submitted: 2023-12-08
• Results First Posted: 2023-12-11
• Last Update Posted: 2023-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bridge Clinic	Bridge Clinic	Medication assisted treatment supervised by addiction bridge clinic until stabilized in treatment.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Self-reported Treatment Retention	6 months	Self-reported enrollment in treatment for opioid use disorder after 6 months

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Illicit Opioid Use	6 months	Urine analyzed for opioids (buprenorphine, methadone, oxycodone, hydrocodone, hydromorphone, heroin, fentanyl) and other drugs (cocaine, amphetamines, benzodiazepines, cannabinoids) via enzyme multiplied immunoassay. Note buprenorphine and methadone positive results not treated as illicit.

Trial Locations

Locations (1)

University of Vermont Medical Center; 🇺🇸 Burlington, Vermont, United States