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

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

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.

Study Overview

• Status: Completed
• Conditions: Drug Overdose; Opioid-use Disorder; Opioid Withdrawal
• Intervention / Treatment: Drug: Buprenorphine

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rates	Percentage of eligible potential participants who enroll in study	Baseline
Acceptability of transferral to outpatient clinic (MOTIVATE)	Percentage of eligible participants who complete additional screenings at MOTIVATE	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Prior to drug administration (within 2 hours after participant is stabilized and consented)

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2018
• Primary Completion (ACTUAL): August 28, 2018
• Study Completion (ACTUAL): August 28, 2018

Study Registration Dates

• First Submitted: March 28, 2018
• First Submitted That Met QC Criteria: March 28, 2018
• First Posted (ACTUAL): April 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 13, 2018
• Last Update Submitted That Met QC Criteria: December 12, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Substance-Related Disorders; Disease Attributes; Narcotic-Related Disorders; Emergencies; Opioid-Related Disorders; Substance Withdrawal Syndrome; Drug Overdose; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine
• Other Study ID Numbers: HM20012543

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