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

NCT03489161 | Completed Early Phase 1 FDA Drug

• 1 other identifier: HM20012543
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Overdose; Opioid Withdrawal; Opioid-use Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Feasibility of 5-Trial Delay Discounting

  Prior to drug administration (within 2 hours after participant is stabilized and consented)

Study Arms (1)

Buprenorphine

EXPERIMENTAL

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

Interventions

Buprenorphine DRUG

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

Buprenorphine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Drug Overdose; Opioid-Related Disorders

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Frederick G Moeller, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: April 5, 2018
• Study Start: August 1, 2018
• Primary Completion: August 28, 2018
• Study Completion: August 28, 2018
• Last Updated: December 13, 2018

Record last verified: 2018-12

Locations

US (1)