Buprenorphine in the Emergency Department

NCT ID: NCT03174067

Last Updated: 2017-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2016-11-30

Brief Summary

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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

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Conditions

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Opioid Withdrawal Opioid-use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Buprenorphine

Patient receives buprenorphine in the emergency room based on a clinical trial protocol as well as a take home prescription for buprenorphine

Group Type EXPERIMENTAL

Buprenorphine

Intervention Type DRUG

The participant receives buprenorphine

Clonidine

Patient receives clonidine in the emergency room based on a clinical trial protocol and also receives a take home prescription for clonidine

Group Type ACTIVE_COMPARATOR

Clonidine

Intervention Type DRUG

The participant receives clonidine

Interventions

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Buprenorphine

The participant receives buprenorphine

Intervention Type DRUG

Clonidine

The participant receives clonidine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Joseph's Health Centre Toronto

OTHER

Sponsor Role lead

Responsible Party

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Anita Srivastava

Staff Physician and Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anita Srivastava, MD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

References

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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.

Reference Type DERIVED
PMID: 31088887 (View on PubMed)

Other Identifiers

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BED2013

Identifier Type: -

Identifier Source: org_study_id

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