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Feasibility of the Utilization of Buprenorphine in the Emergency Room to Treat Clinical Opioid Withdrawal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03489161
Recruitment Status : Completed
First Posted : April 5, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
The investigators are trying to determine whether they can effectively treat patients suffering from acute opioid withdrawal in the Emergency Department at Virginia Commonwealth University Health System (VCUHS) and subsequently transfer them to an outpatient addiction clinic within the existing infrastructure. This will be a descriptive investigation of the process to reveal areas of success and opportunities for improvement in order to determine feasibility of the study procedures in preparation for a larger clinical investigation.

Condition or disease Intervention/treatment Phase
Drug Overdose Opioid Withdrawal Opioid-use Disorder Drug: Buprenorphine Early Phase 1

Detailed Description:

Currently, patients in the Emergency Department at VCUHS experiencing opioid withdrawal, after reversal of opioid intoxication by naloxone, do not receive any direct treatment to stop the symptoms. They do receive indirect treatment aimed at each specific symptom, such as an anti-emetic to stop vomiting. The investigators propose directly treating all of the symptoms with the medication Suboxone, (buprenorphine/naloxone). Buprenorphine is a partial agonist on the Mu-receptor, which means it will provide less opioid effect than morphine, but should provide enough to make opioid withdrawal more tolerable. This is very important because stopping the withdrawal symptoms early will prevent the patient from quickly leaving and using opioids again, continuing their addiction cycle. The naloxone is included with buprenorphine as a deterrent to prevent intravenous injection of the drug for abuse. The investigators believe that if the patient is treated with Suboxone for withdrawal in the emergency department, and transported to the outpatient addiction treatment center at VCU, called the MOTIVATE clinic, the investigators can potentially break that cycle and help the patient work toward recovering. If successful, the investigators hope to improve the quality of life, prevent further overdose and death in those suffering from this deadly addiction.

Buprenorphine effectively treats the opioid withdrawal state. This has been demonstrated in many studies during the initial induction period with buprenorphine. Many of these patients are experiencing opioid withdrawal during this time. The sublingual dose can effectively be increased to resolve symptoms. According to many protocols and guidelines, acute opioid withdrawal is the preferred state of the patient when buprenorphine should be started.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Utilization of Buprenorphine in the Emergency Room to Treat Clinical Opioid Withdrawal
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : August 28, 2018
Actual Study Completion Date : August 28, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Buprenorphine
Buprenorphine administered in the emergency room after patients presenting to the emergency department (ED) due to opioid OD who have been treated with opioid antagonist (naloxone) and are stable and alert.
Drug: Buprenorphine
buprenorphine/naloxone 4mg/1 mg for Clinical Opioid Withdrawal Scale (COWS) scores between 8 and 12, or 8mg/2mg S/L ≥ 12 by the sublingual route




Primary Outcome Measures :
  1. Recruitment rates [ Time Frame: Baseline ]
    Percentage of eligible potential participants who enroll in study

  2. Acceptability of transferral to outpatient clinic (MOTIVATE) [ Time Frame: 48 hours ]
    Percentage of eligible participants who complete additional screenings at MOTIVATE


Secondary Outcome Measures :
  1. Feasibility of 5-Trial Delay Discounting [ Time Frame: Prior to drug administration (within 2 hours after participant is stabilized and consented) ]
    Percentage of consented participants who complete this task, a brief (less than 1 minute) computer based task used to measure an individual's discounting rate when they are presented with the possibility of receiving a real reward



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Opioid overdose only, of any formulation or route, with complete reversal of toxicity after naloxone by any route.
  • RR ≥ 12
  • Pulse oximetry > 95%
  • GCS 15
  • Clinical Opioid Withdrawal Scale (COWS) score ≥ 8

Exclusion Criteria:

  • Pregnancy
  • Prisoner
  • Incomplete reversal of toxicity related to metrics above
  • Police custody
  • Known allergy to buprenorphine
  • Emergent psychiatric condition including active suicidality that requires admission
  • Emergent medical condition that requires admission

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): NCT03489161


Locations
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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Frederick G Moeller, MD Virginia Commonwealth University
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03489161    
Other Study ID Numbers: HM20012543
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018

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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
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Drug Overdose
Substance Withdrawal Syndrome
Pathologic Processes
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists