Clinical trial NCT03818399: Virginia Opioid Overdose Treatment InitiatVE
Official title: Virginia Opioid Overdose Treatment InitiatVE
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Opioid Use Disorder
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Indivior, PLC.
First posted: 2019-01-28
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study is designed to determine effect of SUBLOCADE on repeat overdose and death compared to historical control data.
Primary purpose: TREATMENT

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.

Detailed description: 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 VCU electronic health records. The affiliated clinic will agree to see the subject on arrival at the clinic during normal clinic hours.

Patients presenting to the ED for an opioid overdose (OD) who received treatment with an opioid antagonist and are considered clinically stable and alert will be approached regarding interest in study participation. Written informed consent will only be obtained if the patient's judgement is intact as determined clinically by the investigator or a medically qualified sub-investigator or research nurse. This OD will be considered the index OD.

Subjects will be given the opportunity to participate in an optional pharmacogenetics (PGx) sub-study.

The subject will receive referral to an outpatient treatment clinic affiliated with the hospital system in which the ED resides.

Once subjects arrive at the treatment clinic, they will continue to receive SUBLOCADE for 6 months. All subjects will receive site standard psychosocial therapy at least weekly during the first 3 months of treatment, and twice monthly thereafter if clinically stable.

All subjects will complete an End of Treatment (EOT) / Early Termination (ET) visit 28 days after their last injection of SUBLOCADE. Within 3 months prior to or at the EOT visit, the investigator or a medically qualified sub-investigator will discuss the subject's available treatment options and arrange referral. All subjects will receive a safety follow-up telephone call, 30 days after their EOT/ET visit to assess AEs, SAEs, pregnancy status (if applicable) and concomitant medications. Subjects who decline to continue in medication assisted treatment (MAT) will receive monthly safety follow-up phone calls for an additional 5 months (6 months total) to assess SAEs, pregnancy status (if applicable) and concomitant medications.

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.

Primary outcomes:
measure: Number of Repeat OD or Opioid-related Death
timeFrame: 6 months
Secondary outcomes:
measure: Treatment Engagement
timeFrame: 3 and 6 months
Other outcomes:
measure: Opioid Craving
timeFrame: 6 months
measure: Illicit Opioid Use
timeFrame: 6 months
measure: Genetic Predictors of Treatment Response
timeFrame: 6 months
measure: Healthcare Resource Utilization
timeFrame: 6 months
measure: Treatment Effectiveness and Employment
timeFrame: 6 months
measure: Medication Satisfaction
timeFrame: 6 months
measure: Employment, Presentism and Absenteeism
timeFrame: 6 months
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Frederick G Moeller, MD
role: PRINCIPAL_INVESTIGATOR
References: