STAR: Start Treatment and Recovery for Opioid Use Disorder

Sponsor

University of Vermont (Other)

Overall Status

Recruiting

CT.gov ID

NCT04505540

Collaborator

Substance Abuse and Mental Health Services Administration (SAMHSA) (U.S. Fed), National Institute on Drug Abuse (NIDA) (NIH)

200

Enrollment

Locations

Arms

Anticipated Duration (Months)

66.7

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid-use Disorder Mental Disorder Opioid Medication Assisted Treatment	Other: Bridge Clinic Other: Local Waivered Physician	N/A

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 Design

Study Type:

Interventional

Anticipated 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 :

Sep 30, 2019

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Aug 31, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Urinalysis for illicit opioid use [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 [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 [6 months]
Urine analyzed for opioids (buprenorphine, methadone, oxycodone, hydrocodone, hydromorphone, heroin, fentanyl) and other drugs (cocaine, amphetamines, benzodiazepines, cannabinoids) via enzyme multiplied immunoassay.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Champlain Valley Physician's Hospital	Plattsburgh	New York	United States	12901
2	University of Vermont Medical Center	Burlington	Vermont	United States	05401
3	Porter Medical Center	Middlebury	Vermont	United States	05753

Sponsors and Collaborators

University of Vermont
Substance Abuse and Mental Health Services Administration (SAMHSA)
National Institute on Drug Abuse (NIDA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Scott Mackey, Assistant Professor, University of Vermont

ClinicalTrials.gov Identifier:

NCT04505540

Other Study ID Numbers:

CHRMS: 18-0695
1R21DA049859-01

First Posted:

Aug 10, 2020

Last Update Posted:

Jan 14, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Disease

Opioid-Related Disorders

Substance-Related Disorders

Mental Disorders

Study Results

No Results Posted as of Jan 14, 2022