Buprenorphine in the Emergency Department

Phase 4

Completed

• Conditions: Opioid-use Disorder; Opioid Withdrawal
• Interventions: Drug: Buprenorphine; Drug: Clonidine

• Registration Number: NCT03174067
• Lead Sponsor: St. Joseph's Health Centre Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2016-04
• Study Completion: 2016-11
• Status Verified: 2017-05
• Study First Submitted: 2017-05-24
• Study First Submitted QC: 2017-05-30
• Last Update Submitted: 2017-05-30
• Study First Posted: 2017-06-02
• Last Update Posted: 2017-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1. Presenting to the ED in opioid withdrawal or soon to be in withdrawal
2. Minimum age 16
3. English speaking
4. Active phone number
5. Ontario Health Insurance Program card

Exclusion Criteria

1. Pregnant
2. Currently enrolled in a methadone or buprenorphine maintenance
3. Benzodiazepine addiction (or taking >50mg of valium equivalent/day)
4. Acute hepatitis or liver failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Buprenorphine	Buprenorphine	Patient receives buprenorphine in the emergency room based on a clinical trial protocol as well as a take home prescription for buprenorphine
Clonidine	Clonidine	Patient receives clonidine in the emergency room based on a clinical trial protocol and also receives a take home prescription for clonidine

Primary Outcome Measures

Name	Time	Method
Number of participants attending the rapid access clinic	2-5 days	The number of participants who attend a rapid access clinic assessment after initial enrollment

Secondary Outcome Measures

Name	Time	Method
Number of participants who are on opioid agonist treatment	30 days	The number of participants who are maintained on some form of opioid agonist treatment at the one-month mark