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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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