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Start Treatment and Recovery for Opioid Use Disorder (STAR)

Primary Purpose

Opioid-use Disorder, Mental Disorder, Opioid Medication Assisted Treatment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bridge Clinic
Local Waivered Physician
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Opioid-use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Champlain Valley Physician's Hospital
  • University of Vermont Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bridge Clinic

Local Waivered Physcian

Arm Description

Medication assisted treatment supervised by addiction bridge clinic until stabilized in treatment.

Medication assisted treatment supervised by local waivered physician.

Outcomes

Primary Outcome Measures

Self-report treatment retention
Enrollment in treatment for opioid use disorder after 1 week
Self-report treatment retention
Enrollment in treatment for opioid use disorder after 3 months
Self report treatment retention
Enrollment in treatment for opioid use disorder after 6 months

Secondary Outcome Measures

Urinalysis for 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.
Urinalysis for 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.
Urinalysis for 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.

Full Information

First Posted
June 11, 2020
Last Updated
January 3, 2023
Sponsor
University of Vermont
Collaborators
Substance Abuse and Mental Health Services Administration (SAMHSA), National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04505540
Brief Title
Start Treatment and Recovery for Opioid Use Disorder
Acronym
STAR
Official Title
Effectiveness of Bridge Clinic Following Emergency Department-Initiated Intervention for Opioid Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
Collaborators
Substance Abuse and Mental Health Services Administration (SAMHSA), National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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, and 2) to determine whether emergency department referrals to a bridge clinic improve outcomes relative to direct referrals to a local waivered physician.
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. Differences in outcomes related to whether the patient is referred to a bridge clinic or local provider will be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder, Mental Disorder, Opioid Medication Assisted Treatment

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bridge Clinic
Arm Type
Active Comparator
Arm Description
Medication assisted treatment supervised by addiction bridge clinic until stabilized in treatment.
Arm Title
Local Waivered Physcian
Arm Type
Active Comparator
Arm Description
Medication assisted treatment supervised by local waivered physician.
Intervention Type
Other
Intervention Name(s)
Bridge Clinic
Intervention Description
Specialized addiction bridge clinic
Intervention Type
Other
Intervention Name(s)
Local Waivered Physician
Intervention Description
Direct referral to local waivered physician
Primary Outcome Measure Information:
Title
Self-report treatment retention
Description
Enrollment in treatment for opioid use disorder after 1 week
Time Frame
1 week
Title
Self-report treatment retention
Description
Enrollment in treatment for opioid use disorder after 3 months
Time Frame
3 momths
Title
Self report treatment retention
Description
Enrollment in treatment for opioid use disorder after 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Urinalysis for illicit opioid use
Description
Urine analyzed for opioids (buprenorphine, methadone, oxycodone, hydrocodone, hydromorphone, heroin, fentanyl) and other drugs (cocaine, amphetamines, benzodiazepines, cannabinoids) via enzyme multiplied immunoassay.
Time Frame
1 week
Title
Urinalysis for illicit opioid use
Description
Urine analyzed for opioids (buprenorphine, methadone, oxycodone, hydrocodone, hydromorphone, heroin, fentanyl) and other drugs (cocaine, amphetamines, benzodiazepines, cannabinoids) via enzyme multiplied immunoassay.
Time Frame
3 months
Title
Urinalysis for illicit opioid use
Description
Urine analyzed for opioids (buprenorphine, methadone, oxycodone, hydrocodone, hydromorphone, heroin, fentanyl) and other drugs (cocaine, amphetamines, benzodiazepines, cannabinoids) via enzyme multiplied immunoassay.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Champlain Valley Physician's Hospital
City
Plattsburgh
State/Province
New York
ZIP/Postal Code
12901
Country
United States
Facility Name
University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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