Virginia Opioid Treatment-Emergency Department

NCT04523792 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: HM20020289
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Opioid Use Disorder

Keywords

Opioid use disorder; Opioid withdrawal; Emergency department; Treatment-seeking; Opioid agonist treatment; Sublocade

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Treatment engagement - 3 and 6 months

  3 and 6 months

• Number of repeat ED visits

  6 months

Other Outcomes (9)

• Healthcare resource utilization

  6 months

• Opioid craving

  6 months

• Number of participants with a urine drug screen negative for illicit opioids.

  6 months

Study Arms (1)

Opioid withdrawal patients

EXPERIMENTAL

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

Interventions

SUBLOCADE DRUG

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.

Opioid withdrawal patients

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Indivior, PLC.: collaborator

MeSH Terms

Conditions

Opioid-Related Disorders; Emergencies

Interventions

Sublocade

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Frederick G Moeller, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is designed to examine feasibility of SUBLOCADE on outpatient treatment engagement compared to historical and concurrent control groups.

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 24, 2020
• Study Start: January 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 12, 2021

Record last verified: 2021-02