Buprenorphine in the Emergency Department (BED)

May 30, 2017 updated by: Anita Srivastava, St. Joseph's Health Centre Toronto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Buprenorphine
Patient receives buprenorphine in the emergency room based on a clinical trial protocol as well as a take home prescription for buprenorphine
Drug: Buprenorphine
The participant receives buprenorphine
ACTIVE_COMPARATOR: Clonidine
Patient receives clonidine in the emergency room based on a clinical trial protocol and also receives a take home prescription for clonidine
Drug: Clonidine
The participant receives clonidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants attending the rapid access clinic
Time Frame: 2-5 days
The number of participants who attend a rapid access clinic assessment after initial enrollment
2-5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who are on opioid agonist treatment
Time Frame: 30 days
The number of participants who are maintained on some form of opioid agonist treatment at the one-month mark
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Joseph's Health Centre Toronto

Investigators

  • Principal Investigator: Anita Srivastava, MD, University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2013

Primary Completion (ACTUAL)

April 1, 2016

Study Completion (ACTUAL)

November 1, 2016

Study Registration Dates

First Submitted

May 24, 2017

First Submitted That Met QC Criteria

May 30, 2017

First Posted (ACTUAL)

June 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 2, 2017

Last Update Submitted That Met QC Criteria

May 30, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BED2013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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