Back to resultsBuprenorphine in the Emergency Department (BED)
Primary Purpose
Opioid Withdrawal, Opioid-use Disorder
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Buprenorphine
Clonidine
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Withdrawal focused on measuring buprenorphine, emergency department
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pregnant
- Currently enrolled in a methadone or buprenorphine maintenance
- Benzodiazepine addiction (or taking >50mg of valium equivalent/day)
- Acute hepatitis or liver failure
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Buprenorphine
Clonidine
Arm Description
Patient receives buprenorphine in the emergency room based on a clinical trial protocol as well as a take home prescription for buprenorphine
Patient receives clonidine in the emergency room based on a clinical trial protocol and also receives a take home prescription for clonidine
Outcomes
Primary Outcome Measures
Number of participants attending the rapid access clinic
The number of participants who attend a rapid access clinic assessment after initial enrollment
Secondary Outcome Measures
Number of participants who are on opioid agonist treatment
The number of participants who are maintained on some form of opioid agonist treatment at the one-month mark
Full Information
NCT ID
NCT03174067
First Posted
May 24, 2017
Last Updated
May 30, 2017
Sponsor
St. Joseph's Health Centre Toronto
1. Study Identification
Unique Protocol Identification Number
NCT03174067
Brief Title
Buprenorphine in the Emergency Department
Acronym
BED
Official Title
Buprenorphine in the Emergency Department: Buprenorphine Versus Clonidine for Opioid Withdrawal
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Health Centre Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Withdrawal, Opioid-use Disorder
Keywords
buprenorphine, emergency department
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Buprenorphine
Arm Type
Experimental
Arm Description
Patient receives buprenorphine in the emergency room based on a clinical trial protocol as well as a take home prescription for buprenorphine
Arm Title
Clonidine
Arm Type
Active Comparator
Arm Description
Patient receives clonidine in the emergency room based on a clinical trial protocol and also receives a take home prescription for clonidine
Intervention Type
Drug
Intervention Name(s)
Buprenorphine
Intervention Description
The participant receives buprenorphine
Intervention Type
Drug
Intervention Name(s)
Clonidine
Intervention Description
The participant receives clonidine
Primary Outcome Measure Information:
Title
Number of participants attending the rapid access clinic
Description
The number of participants who attend a rapid access clinic assessment after initial enrollment
Time Frame
2-5 days
Secondary Outcome Measure Information:
Title
Number of participants who are on opioid agonist treatment
Description
The number of participants who are maintained on some form of opioid agonist treatment at the one-month mark
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Pregnant
Currently enrolled in a methadone or buprenorphine maintenance
Benzodiazepine addiction (or taking >50mg of valium equivalent/day)
Acute hepatitis or liver failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anita Srivastava, MD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31088887
Citation
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.
Results Reference
derived
Learn more about this trial
Buprenorphine in the Emergency Department
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