Clinical trial NCT03489161: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Drug Overdose
Opioid Withdrawal
Opioid-use Disorder
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2018-04-05
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Recruitment rates
timeFrame: Baseline
measure: Acceptability of transferral to outpatient clinic (MOTIVATE)
timeFrame: 48 hours
Secondary outcomes:
measure: Feasibility of 5-Trial Delay Discounting
timeFrame: Prior to drug administration (within 2 hours after participant is stabilized and consented)
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Frederick G Moeller, MD
role: PRINCIPAL_INVESTIGATOR
References: