Buprenorphine in the Emergency Department

Opioid-use Disorder Clinical Trial

— BED  

Official title:

Buprenorphine in the Emergency Department: Buprenorphine Versus Clonidine for Opioid Withdrawal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03174067
• Other study ID #: BED2013
• Status: Completed
• Phase: Phase 4
• First received: May 24, 2017
• Last updated: May 30, 2017
• Start date: March 2013
• Est. completion date: November 2016

Study information

• Verified date: May 2017
• Source: St. Joseph's Health Centre Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Opioid Withdrawal
• Opioid-use Disorder
• Substance Withdrawal Syndrome

Intervention

Drug:
• Buprenorphine
The participant receives buprenorphine
• Clonidine
The participant receives clonidine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Health Centre Toronto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	30 days