Start Treatment and Recovery for Opioid Use Disorder
STAR
Effectiveness of Bridge Clinic Following Emergency Department-Initiated Intervention for Opioid Use Disorder
2 other identifiers
interventional
104
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 30, 2019
CompletedFirst Submitted
Initial submission to the registry
June 11, 2020
CompletedFirst Posted
Study publicly available on registry
August 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2022
CompletedResults Posted
Study results publicly available
December 11, 2023
CompletedDecember 11, 2023
December 1, 2023
3.1 years
June 11, 2020
November 1, 2023
December 8, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Number of Participants With Self-reported Treatment Retention
Self-reported enrollment in treatment for opioid use disorder after 1 week
1 week
Number of Participants With Self-reported Treatment Retention
Self-reported enrollment in treatment for opioid use disorder after 3 months
3 months
Number of Participants With Self-reported Treatment Retention
Self-reported enrollment in treatment for opioid use disorder after 6 months
6 months
Secondary Outcomes (3)
Number of Participants With Illicit Opioid Use
1 week
Number of Participants With Illicit Opioid Use
3 months
Number of Participants With Illicit Opioid Use
6 months
Study Arms (1)
Bridge Clinic
EXPERIMENTALMedication assisted treatment supervised by addiction bridge clinic until stabilized in treatment.
Interventions
Eligibility Criteria
You may qualify if:
- Patient at Emergency Department
- Diagnosis opioid use disorder according to criteria Diagnostic and Statistical Manual (DSM) 5
You may not qualify if:
- Participating in alternate treatment program for opioid use disorder
- Prisoner
- Inability to communicate
- Psychosis
- Suicidality
- History of Buprenorphine injection
- Critical Illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Urinalysis was disrupted by the COVID-19 epidemic. Consequently, urinalysis at 1 week, 3 months, and 6 months (although reported) should be regarded with caution.
Results Point of Contact
- Title
- Dr. Scott Mackey, PhD
- Organization
- University of Vermont
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 11, 2020
First Posted
August 10, 2020
Study Start
September 30, 2019
Primary Completion
October 31, 2022
Study Completion
October 31, 2022
Last Updated
December 11, 2023
Results First Posted
December 11, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share