Buprenorphine in the Emergency Department
BED
1 other identifier
interventional
26
0 countries
N/A
Brief Summary
This is a pilot randomized control trial randomizing patients presenting in opioid withdrawal to the emergency department to receive either one of clonidine (usual standard of care) or buprenorphine for their opioid withdrawal. Primary treatment outcome is attendance at a rapid access addiction medicine clinic within a few days of emergency room presentation. Secondary treatment outcome is treatment status with respect to opioid agonist treatment at one month post emergency room visit.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Mar 2013
Longer than P75 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 24, 2017
CompletedFirst Posted
Study publicly available on registry
June 2, 2017
CompletedJune 2, 2017
May 1, 2017
3.1 years
May 24, 2017
May 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants attending the rapid access clinic
The number of participants who attend a rapid access clinic assessment after initial enrollment
2-5 days
Secondary Outcomes (1)
Number of participants who are on opioid agonist treatment
30 days
Study Arms (2)
Buprenorphine
EXPERIMENTALPatient receives buprenorphine in the emergency room based on a clinical trial protocol as well as a take home prescription for buprenorphine
Clonidine
ACTIVE COMPARATORPatient receives clonidine in the emergency room based on a clinical trial protocol and also receives a take home prescription for clonidine
Interventions
Eligibility Criteria
You may qualify if:
- Presenting to the ED in opioid withdrawal or soon to be in withdrawal
- Minimum age 16
- English speaking
- Active phone number
- Ontario Health Insurance Program card
You may not qualify if:
- Pregnant
- Currently enrolled in a methadone or buprenorphine maintenance
- Benzodiazepine addiction (or taking \>50mg of valium equivalent/day)
- Acute hepatitis or liver failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Srivastava A, Kahan M, Njoroge I, Sommer LZ. Buprenorphine in the emergency department: Randomized clinical controlled trial of clonidine versus buprenorphine for the treatment of opioid withdrawal. Can Fam Physician. 2019 May;65(5):e214-e220.
PMID: 31088887DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anita Srivastava, MD
University of Toronto
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff Physician and Associate Professor
Study Record Dates
First Submitted
May 24, 2017
First Posted
June 2, 2017
Study Start
March 1, 2013
Primary Completion
April 1, 2016
Study Completion
November 1, 2016
Last Updated
June 2, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share