Virginia Opioid Treatment-Emergency Department

Study Overview
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Brief Summary
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The current study seeks to test the feasibility of an alternative treatment for patients with opioid use disorder who present to the emergency department seeking treatment or with opioid withdrawal, which includes FDA approved long-acting medication for opioid misuse (SUBLOCADE) and rapid transfer of care to outpatient substance abuse treatment.

Detailed Description
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This proof of concept study will provide feasibility data on whether rapid initiation of SUBLOCADE® (buprenorphine extended-release) injection for subcutaneous use CIII in the ED, Clinical Decision Unit, or inpatient unit and after administration of a test dose of SUBOXONE® (buprenorphine and naloxone) sublingual film, for sublingual or buccal use CIII among treatment-seeking adults with moderate or severe OUD increases subsequent outpatient treatment engagement as compared to a historical control cohort and concurrent controls who decline treatment participation. The study will also assess whether rapid initiation of SUBLOCADE® reduces subsequent ED visits for any reason. As a exploratory aim we will examine whether rapid initiation of Sublocade in this patient group reduces opioid overdose events compared to historical controls and patients who decline Sublocade.

Official Title
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Virginia Opioid Treatment-Emergency Department

Conditions
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Opioid Use Disorder

Intervention / Treatment
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* Drug: SUBLOCADE


Participation Criteria
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Eligibility Criteria
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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 OUD. Is clinically stable (respiratory rate [RR] ≥ 12, pulse oximetry > 95%, Glasgow Coma Scale [GCS] score of 15) and suitable for the trial in investigator's 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 (BP, HR, temperature) considered within normal limits or non-clinically significant elevation, as assessed by treating physician. Provide a urine drug screen positive for illicit opioids, excluding methadone. Have a COWS score ≥ 8. Is seeking medication-assisted treatment for OUD. Exclusion Criteria: Current diagnosis, other than OUD, requiring chronic opioid treatment. Active suicidal ideation in opinion of the 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 that would limit compliance with study requirements or compromise the ability of the subject to provide written informed consent. Known allergy or hypersensitivity to SUBOXONE or SUBLOCADE. Any condition that, in the opinion of the Investigator would interfere with interpretation of subject safety or study results. Currently receiving methadone, depot naltrexone, or Probuphine for OUD or received those treatments for OUD within 30 days prior to consent. Current or concurrent treatment with an investigational agent. Current or concurrent enrollment in another clinical study, or observational study that includes MAT. Treatment for OUD 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 (i.e., 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 (i.e., 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. If these results are unable to be obtained prior to enrolling the subject, the investigator can make an initial determination about eligibility based on LFTs collected in the past 6 months from the subject's medical record. 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 medications that prolong the QT interval.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The study is designed to examine feasibility of SUBLOCADE on outpatient treatment engagement compared to historical and concurrent control groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Opioid withdrawal patients<br>Subjects with opioid use disorder seeking treatment and/or experiencing symptoms of opioid withdrawal receive acute administration of SUBOXONE sublingual film followed by SUBLOCADE administration in the 1) ED, 2) Clinical Decision Unit or 3) Inpatient unit combined with 6 months of treatment with SUBLOCADE in the outpatient treatment clinic. | Drug: SUBLOCADE<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment engagement - 1 month | Treatment engagement as measured by percentage of participants who attend an outpatient clinic visit within 1 month of first injection. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment engagement - 3 and 6 months | Treatment engagement as measured by percentage of participants who continue to attend outpatient clinic visits with SUBLOCADE injections (buprenorphine treatment) at 3 and 6 months. | 3 and 6 months | 
| Number of repeat ED visits | Number of repeat ED visits for any reason will be measured from electronic medical records and self-reported data. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid use disorder, Opioid withdrawal, Emergency department, Treatment-seeking, Opioid agonist treatment, Sublocade