Virginia Opioid Overdose Treatment InitiatVE

NCT03818399 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: HM20015109
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (1)

• Number of Repeat OD or Opioid-related Death

  Repeat OD or opioid-related death will be measured from electronic medical records and state death registries

  6 months

Secondary Outcomes (1)

• Treatment Engagement

  3 and 6 months

Other Outcomes (7)

• Opioid Craving

  6 months

• Illicit Opioid Use

  6 months

• Genetic Predictors of Treatment Response

  6 months

Study Arms (1)

overdose patients

EXPERIMENTAL

subjects that receive acute administration of SUBOXONE sublingual film in the ED followed by SUBLOCADE administration in the ED and referral to an affiliated outpatient treatment clinic, and receive monthly SUBLOCADE injections for 6 months in the context of outpatient treatment.

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.

overdose 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Sublocade

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Roy Sabo, PhD
• Organization: Virginia Commonwealth University

roy.sabo@vcuhealth.org

804-828-3047

Study Officials

• Frederick G Moeller, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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 determine effect of SUBLOCADE on repeat overdose and death compared to historical control data.

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: January 28, 2019
• Study Start: January 4, 2019
• Primary Completion: February 24, 2021
• Study Completion: February 24, 2021
• Last Updated: May 5, 2022
• Results First Posted: May 5, 2022

Record last verified: 2022-04

Locations

US (1)