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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

Tracking Information
First Submitted Date  ICMJE June 11, 2020
First Posted Date  ICMJE August 10, 2020
Last Update Posted Date August 10, 2020
Actual Study Start Date  ICMJE September 30, 2019
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2020)
  • Self-report treatment retention [ Time Frame: 1 week ]
    Enrollment in treatment for opioid use disorder after 1 week
  • Self-report treatment retention [ Time Frame: 3 momths ]
    Enrollment in treatment for opioid use disorder after 3 months
  • Self report treatment retention [ Time Frame: 6 months ]
    Enrollment in treatment for opioid use disorder after 6 months
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2020)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Start Treatment and Recovery for Opioid Use Disorder
Official Title  ICMJE Effectiveness of Bridge Clinic Following Emergency Department-Initiated Intervention for Opioid Use Disorder
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Opioid-use Disorder
  • Mental Disorder
  • Opioid Medication Assisted Treatment
Intervention  ICMJE
  • Other: Bridge Clinic
    Specialized addiction bridge clinic
  • Other: Local Waivered Physician
    Direct referral to local waivered physician
Study Arms  ICMJE
  • Active Comparator: Bridge Clinic
    Medication assisted treatment supervised by addiction bridge clinic until stabilized in treatment.
    Intervention: Other: Bridge Clinic
  • Active Comparator: Local Waivered Physcian
    Medication assisted treatment supervised by local waivered physician.
    Intervention: Other: Local Waivered Physician
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 5, 2020)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2021
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michael S Mackey, PhD (802) 847-8767 msmackey@uvm.edu
Contact: Roz Bidad, RN (802) 847-8174 Roz.Bidad@uvmhealth.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04505540
Other Study ID Numbers  ICMJE CHRMS: 18-0695
1R21DA049859-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Scott Mackey, University of Vermont
Study Sponsor  ICMJE University of Vermont
Collaborators  ICMJE
  • Substance Abuse and Mental Health Services Administration (SAMHSA)
  • National Institute on Drug Abuse (NIDA)
Investigators  ICMJE Not Provided
PRS Account University of Vermont
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP