Virginia Opioid Overdose Treatment InitiatVE
Condition: Opioid Use Disorder
MeSH terms: Opioid-Related Disorders; Opiate Overdose
Intervention: SUBLOCADE
Intervention description: SUBLOCADE (buprenorphine extended-release) injection is a colorless to amber sterile solution for SC injection designed to deliver buprenorphine at doses of 100 mg or 300 mg at a controlled rate over a one-month period.
Intervention MeSH terms: Buprenorphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: The study is designed to determine effect of SUBLOCADE on repeat overdose and death compared to historical control data.
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 3b, open-label study in patients that present to the ED for an opioid OD and
      receive treatment with an opioid antagonist. The study is designed to determine effect of
      SUBLOCADE on repeat overdose and death compared to historical control data.

      The study will assess subjects that receive acute administration of SUBOXONE sublingual film
      in the Emergency Department (ED) followed by SUBLOCADE administration in the ED and referral
      to an affiliated outpatient treatment clinic, compared to historical control data from
      electronic health records.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed the informed consent form (ICF) and have the ability to comply with the
             requirements and restrictions listed therein.

          -  Age: ≥ 18 years at time of executing the ICF.

          -  Currently meets DSM-5 criteria for moderate to severe opioid use disorder.

          -  Must have Clinical Opioid Withdrawal Scale (COWS) score of >8 to be eligible for
             SUBOXONE dose.

          -  Is clinically stable (respiratory rate [RR] ≥ 12, pulse oximetry > 95%, Glasgow Coma
             Scale [GCS] score of 15) and suitable for the trial in investigator or designee's
             judgement.

          -  Agrees not to take any buprenorphine products other than those administered during the
             current study throughout participation in the study.

          -  Negative urine pregnancy test for females.

          -  Vital signs (blood pressure, heart rate, temperature) considered within normal limits
             or non-clinically significant elevation, as assessed by treating physician.

        Exclusion Criteria:

          -  Current diagnosis, other than opioid use disorder, requiring chronic opioid treatment.

          -  Active suicidal ideation in opinion of investigator or designee.

          -  Female subject that is lactating, pregnant or planning to become pregnant during their
             participation in the study.

          -  Uncontrolled intercurrent illness including, but not limited to, psychiatric
             illness/social situations that would limit compliance with study requirements or
             compromise the ability of the subject to provide written informed consent, signs of
             opioid toxicity more than 2 hours from naloxone administration or subjects with
             evidence of pulmonary edema.

          -  Known allergy or hypersensitivity to SUBOXONE.

          -  Any condition that, in the opinion of the investigator would interfere with
             interpretation of subject safety or study results.

          -  Currently receiving medication assisted treatment (MAT) for opioid use disorder (OUD)
             (e.g. methadone, buprenorphine) or received MAT as a treatment for OUD within 30 days
             prior to consent.

          -  Concurrent treatment with another investigational agent.

          -  Concurrent enrolment in another clinical study, or observational study that includes
             MAT.

          -  Treatment for opioid use disorder required by court order.

          -  Current or pending incarceration/ legal action that could affect participation or
             compliance in the study.

          -  Subjects who are unable, in the opinion of the investigator, to comply fully with the
             study requirements.

          -  Less than 48-72 hours since last use of long acting opioids (e.g., methadone), by
             self-report.

          -  Current intoxication with benzodiazepines or alcohol.

          -  Meet current DSM-5 diagnosis for severe Benzodiazepine or Alcohol Use Disorder, or
             endorse benzodiazepine or alcohol withdrawal symptoms.

          -  Current illicit opioid users who endorse regular use of long acting opioids (e.g.
             methadone).

          -  Total bilirubin ≥ 1.5x the upper limit of normal (ULN), alanine aminotransferase (ALT)
             ≥3xULN, aspartate aminotransferase (AST) ≥ 3xULN, serum creatinine > 2xULN,
             international normalized ratio (INR) >1.5xULN

          -  Patients with a history of Long QT Syndrome or an immediate family member with this
             condition or those taking Class lA antiarrhythmic medications (e.g., quinidine,
             procainamide, disopyramide) or Class Ill antiarrhythmic medications (e.g., sotalol,
             amiodarone, or other mediations that prolong the QT interval.