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Start Treatment and Recovery for Opioid Use Disorder (STAR)

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ClinicalTrials.gov Identifier: NCT04505540
Recruitment Status : Recruiting
First Posted : August 10, 2020
Last Update Posted : August 10, 2020
Sponsor:
Collaborators:
Substance Abuse and Mental Health Services Administration (SAMHSA)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Scott Mackey, University of Vermont

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.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Mental Disorder Opioid Medication Assisted Treatment Other: Bridge Clinic Other: Local Waivered Physician Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effectiveness of Bridge Clinic Following Emergency Department-Initiated Intervention for Opioid Use Disorder
Actual Study Start Date : September 30, 2019
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Arm Intervention/treatment
Active Comparator: Bridge Clinic
Medication assisted treatment supervised by addiction bridge clinic until stabilized in treatment.
Other: Bridge Clinic
Specialized addiction bridge clinic

Active Comparator: Local Waivered Physcian
Medication assisted treatment supervised by local waivered physician.
Other: Local Waivered Physician
Direct referral to local waivered physician




Primary Outcome Measures :
  1. Self-report treatment retention [ Time Frame: 1 week ]
    Enrollment in treatment for opioid use disorder after 1 week

  2. Self-report treatment retention [ Time Frame: 3 momths ]
    Enrollment in treatment for opioid use disorder after 3 months

  3. Self report treatment retention [ Time Frame: 6 months ]
    Enrollment in treatment for opioid use disorder after 6 months


Secondary Outcome Measures :
  1. Urinalysis for 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.

  2. Urinalysis for 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.

  3. Urinalysis for 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04505540


Contacts
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Contact: Michael S Mackey, PhD (802) 847-8767 msmackey@uvm.edu
Contact: Roz Bidad, RN (802) 847-8174 Roz.Bidad@uvmhealth.org

Locations
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United States, New York
Champlain Valley Physician's Hospital Not yet recruiting
Plattsburgh, New York, United States, 12901
Contact: Roz Bidad, RN    802-847-8174    Roz.Bidad@uvmhealth.org   
United States, Vermont
University of Vermont Medical Center Recruiting
Burlington, Vermont, United States, 05401
Contact: Roz Bidad, RN    802-847-8174    Roz.Bidad@uvmhealth.org   
Porter Medical Center Not yet recruiting
Middlebury, Vermont, United States, 05753
Contact: Roz Bidad, RN    802-847-8174    Roz.Bidad@uvmhealth.org   
Sponsors and Collaborators
University of Vermont
Substance Abuse and Mental Health Services Administration (SAMHSA)
National Institute on Drug Abuse (NIDA)
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Responsible Party: Scott Mackey, Assistant Professor, University of Vermont
ClinicalTrials.gov Identifier: NCT04505540    
Other Study ID Numbers: CHRMS: 18-0695
1R21DA049859-01 ( U.S. NIH Grant/Contract )
First Posted: August 10, 2020    Key Record Dates
Last Update Posted: August 10, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Substance-Related Disorders
Mental Disorders
Pathologic Processes
Chemically-Induced Disorders