Feasibility of the Utilization of Buprenorphine in the Emergency Room to Treat Clinical Opioid Withdrawal
Condition: Drug Overdose; Opioid Withdrawal; Opioid-use Disorder
MeSH terms: Emergencies; Opioid-Related Disorders; Drug Overdose; Substance Withdrawal Syndrome
Study type: Interventional
Phase: Early Phase 1

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.
    

Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention description(s): 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
Intervention MeSH terms: Buprenorphine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment