Opioid Use DisorderPhase 3VOT-EDNCT04523792
Virginia Opioid Treatment-Emergency Department
A Phase 3 study testing SUBLOCADE in people with Opioid Use Disorder, run by Virginia Commonwealth University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- SUBLOCADE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 31 Dec 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
About this study
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.
Read the detailed description
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.
- Conditions
- Opioid Use Disorder
- Being tested
- SUBLOCADE
- Keywords
- Opioid use disorder, Opioid withdrawal, Emergency department, Treatment-seeking, Opioid agonist treatment, Sublocade
- Medical subject headings
- Opioid-Related Disorders, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUBLOCADEDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: SUBLOCADE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment engagement - 1 month
Treatment engagement as measured by percentage of participants who attend an outpatient clinic visit within 1 month of first injection.
Measured: 1 month
Secondary outcomes (2)
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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start1 Jan 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Why it stopped: Funder has not approved protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Indivior, PLC.
- Responsible party
- Sponsor
- Investigators
- Frederick G Moeller, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523792
- Sponsor's protocol ID
- HM20020289
- Acronym
- VOT-ED
- Status last verified
- Feb 2021
- First submitted
- 19 Aug 2020
- Last updated
- 12 Feb 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virginia Opioid Treatment-Emergency Department
- ClinicalTrials.gov ID
- NCT04523792
- Acronym / sponsor ID
- VOT-ED / HM20020289
- Conditions
- Opioid Use Disorder
- Keywords
- Opioid use disorder, Opioid withdrawal, Emergency department, Treatment-seeking, Opioid agonist treatment, Sublocade
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funder has not approved protocol
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Indivior, PLC.
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 24 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is designed to examine feasibility of SUBLOCADE on outpatient treatment engagement compared to historical and concurrent control groups.
| Arm | Type | Receives |
|---|---|---|
| Opioid withdrawal patients | Experimental | Drug: SUBLOCADESubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SUBLOCADESUBLOCADE (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. | Drug | Opioid withdrawal patients |
Primary outcome
Treatment engagement - 1 month
Time frame: 1 month
Treatment engagement as measured by percentage of participants who attend an outpatient clinic visit within 1 month of first injection.
2 secondary outcomes
Treatment engagement - 3 and 6 months
Time frame: 3 and 6 months
Number of repeat ED visits
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick G Moeller, MD principal investigator
Virginia Commonwealth University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SUBLOCADE in people with Opioid Use Disorder, run by Virginia Commonwealth University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment engagement - 1 month (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021.