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Completed

NCT Number: NCT04505540

Start Treatment and Recovery for Opioid Use Disorder

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.

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Key information

Conditions

Opioid-use Disorder Chemically-Induced Disorders Mental Disorder Mental Disorders Narcotic-Related Disorders Opioid Medication Assisted Treatment Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bridge Clinic

Other

Specialized addiction bridge clinic

Primary outcomes

  1. Number of Participants With Self-reported Treatment Retention

    Time frame: 1 week

    Self-reported enrollment in treatment for opioid use disorder after 1 week

  2. Number of Participants With Self-reported Treatment Retention

    Time frame: 3 months

    Self-reported enrollment in treatment for opioid use disorder after 3 months

  3. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • Substance Abuse and Mental Health Services Administration (SAMHSA)

Registry information

Official study title

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

Acronym: STAR

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 10, 2020
Registry last updated
Dec 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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