Feasibility of the Utilization of Buprenorphine in the Emergency Room to Treat Clinical Opioid Withdrawal
Primary Purpose
Drug Overdose, Opioid Withdrawal, Opioid-use Disorder
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine
Sponsored by
About this trial
This is an interventional treatment trial for Drug Overdose
Eligibility 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
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Buprenorphine
Arm Description
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.
Outcomes
Primary Outcome Measures
Recruitment rates
Percentage of eligible potential participants who enroll in study
Acceptability of transferral to outpatient clinic (MOTIVATE)
Percentage of eligible participants who complete additional screenings at MOTIVATE
Secondary Outcome Measures
Feasibility of 5-Trial Delay Discounting
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
Full Information
NCT ID
NCT03489161
First Posted
March 28, 2018
Last Updated
December 12, 2018
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT03489161
Brief Title
Feasibility of the Utilization of Buprenorphine in the Emergency Room to Treat Clinical Opioid Withdrawal
Official Title
The Utilization of Buprenorphine in the Emergency Room to Treat Clinical Opioid Withdrawal
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
August 28, 2018 (Actual)
Study Completion Date
August 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
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
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Overdose, Opioid Withdrawal, Opioid-use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Buprenorphine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Buprenorphine
Intervention Description
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 Measure Information:
Title
Recruitment rates
Description
Percentage of eligible potential participants who enroll in study
Time Frame
Baseline
Title
Acceptability of transferral to outpatient clinic (MOTIVATE)
Description
Percentage of eligible participants who complete additional screenings at MOTIVATE
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Feasibility of 5-Trial Delay Discounting
Description
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
Time Frame
Prior to drug administration (within 2 hours after participant is stabilized and consented)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick G Moeller, MD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Feasibility of the Utilization of Buprenorphine in the Emergency Room to Treat Clinical Opioid Withdrawal
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