Start Treatment and Recovery for Opioid Use Disorder

Opioid-use Disorder Clinical Trial

— STAR  

Official title:

Effectiveness of Bridge Clinic Following Emergency Department-Initiated Intervention for Opioid Use Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04505540
• Other study ID #: CHRMS: 18-0695
• Secondary ID: 1R21DA049859-01
• Status: Completed
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: October 31, 2022

Study information

• Verified date: December 2023
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorder
• Mental Disorders
• Opioid Medication Assisted Treatment
• Opioid-Related Disorders
• Opioid-use Disorder
• Substance-Related Disorders

Intervention

Other:
• Bridge Clinic
Specialized addiction bridge clinic

Locations

Country	Name	City	State
United States	University of Vermont Medical Center	Burlington	Vermont

Sponsors (3)

Lead Sponsor	Collaborator
University of Vermont	National Institute on Drug Abuse (NIDA), Substance Abuse and Mental Health Services Administration (SAMHSA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Self-reported Treatment Retention	Self-reported enrollment in treatment for opioid use disorder after 1 week	1 week
Primary	Number of Participants With Self-reported Treatment Retention	Self-reported enrollment in treatment for opioid use disorder after 3 months	3 months
Primary	Number of Participants With Self-reported Treatment Retention	Self-reported enrollment in treatment for opioid use disorder after 6 months	6 months
Secondary	Number of Participants With Illicit Opioid Use	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.	1 week
Secondary	Number of Participants With Illicit Opioid Use	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.	3 months
Secondary	Number of Participants With Illicit Opioid Use	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.	6 months