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

Opioid-use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03489161
• Other study ID #: HM20012543
• Status: Completed
• Phase: Early Phase 1
• Start date: August 1, 2018
• Est. completion date: August 28, 2018

Study information

• Verified date: December 2018
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: August 28, 2018
• Est. primary completion date: August 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Overdose
• Emergencies
• Opioid Withdrawal
• Opioid-use Disorder
• Substance Withdrawal Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rates	Percentage of eligible potential participants who enroll in study	Baseline
Primary	Acceptability of transferral to outpatient clinic (MOTIVATE)	Percentage of eligible participants who complete additional screenings at MOTIVATE	48 hours
Secondary	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)