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Trial record 96 of 326 for:    clonidine

Buprenorphine in the Emergency Department (BED)

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ClinicalTrials.gov Identifier: NCT03174067
Recruitment Status : Completed
First Posted : June 2, 2017
Last Update Posted : June 2, 2017
Sponsor:
Information provided by (Responsible Party):
Anita Srivastava, 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.

Condition or disease Intervention/treatment Phase
Opioid Withdrawal Opioid-use Disorder Drug: Buprenorphine Drug: Clonidine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Buprenorphine in the Emergency Department: Buprenorphine Versus Clonidine for Opioid Withdrawal
Actual Study Start Date : March 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03174067


Sponsors and Collaborators
St. Joseph's Health Centre Toronto
Investigators
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Principal Investigator: Anita Srivastava, MD University of Toronto

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anita Srivastava, Staff Physician and Associate Professor, St. Joseph's Health Centre Toronto
ClinicalTrials.gov Identifier: NCT03174067     History of Changes
Other Study ID Numbers: BED2013
First Posted: June 2, 2017    Key Record Dates
Last Update Posted: June 2, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Anita Srivastava, St. Joseph's Health Centre Toronto:
buprenorphine
emergency department
Additional relevant MeSH terms:
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Clonidine
Emergencies
Disease Attributes
Pathologic Processes
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action