Start Treatment and Recovery for Opioid Use Disorder

Overview

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.

Full Title of Study: “Effectiveness of Bridge Clinic Following Emergency Department-Initiated Intervention for Opioid Use Disorder”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 31, 2022

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.

Interventions

  • Other: Bridge Clinic
    • Specialized addiction bridge clinic

Arms, Groups and Cohorts

  • Experimental: Bridge Clinic
    • Medication assisted treatment supervised by addiction bridge clinic until stabilized in treatment.

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With Self-reported Treatment Retention
    • Time Frame: 1 week
    • Self-reported enrollment in treatment for opioid use disorder after 1 week
  • Number of Participants With Self-reported Treatment Retention
    • Time Frame: 3 months
    • Self-reported enrollment in treatment for opioid use disorder after 3 months
  • Number of Participants With Self-reported Treatment Retention
    • Time Frame: 6 months
    • Self-reported enrollment in treatment for opioid use disorder after 6 months

Secondary Measures

  • Number of Participants With Illicit Opioid Use
    • Time Frame: 1 week
    • 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.
  • Number of Participants With Illicit Opioid Use
    • Time Frame: 3 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.
  • Number of Participants With Illicit Opioid Use
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Vermont
  • Collaborator
    • Substance Abuse and Mental Health Services Administration (SAMHSA)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Scott Mackey, Assistant Professor – University of Vermont

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.