Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Virginia Opioid Overdose Treatment InitiatVE (VOTIVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03818399
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : January 28, 2019
Sponsor:
Collaborator:
Indivior Inc.
Information provided by (Responsible Party):
Virginia Commonwealth University

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.


Condition or disease Intervention/treatment Phase
Opioid Use Disorder Drug: SUBLOCADE Phase 3

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Intervention Model Description: The study is designed to determine effect of SUBLOCADE on repeat overdose and death compared to historical control data.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Virginia Opioid Overdose Treatment InitiatVE
Actual Study Start Date : January 4, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: overdose patients
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
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.




Primary Outcome Measures :
  1. Time to repeat OD or opioid-related death [ Time Frame: 6 months ]
    Repeat OD or opioid-related death will be measured from electronic medical records and state death registries


Secondary Outcome Measures :
  1. Treatment engagement [ Time Frame: 3 and 6 months ]
    Treatment engagement as measured by number of outpatient clinic visits (attendance), receipt of SUBLOCADE injections (buprenorphine treatment) at 3 and 6 months.


Other Outcome Measures:
  1. Opioid craving [ Time Frame: 6 months ]
    Opioid craving in subjects as measured by Craving Visual Analog Scale (VAS), a 3-item scale in which individuals rate their cravings for opioids on a scale from 0 (NOT AT ALL) to 10 (EXTREMELY)

  2. Illicit opioid use [ Time Frame: 6 months ]
    Illicit opioid use as measured by urine drug screen (UDS) results.

  3. Genetic predictors of treatment response [ Time Frame: 6 months ]
    Number of participants with mu opioid receptor polymorphisms associated with repeat overdose and death history of OD in subjects

  4. Healthcare resource utilization [ Time Frame: 6 months ]
    Healthcare resource utilization (measured by number of outpatient clinic and emergency department visits, and number of inpatient admissions) as compared to the historical controls

  5. Treatment effectiveness and employment [ Time Frame: 6 months ]
    Treatment effectiveness as measured by Treatment Effectiveness Assessment (TEA)

  6. Medication satisfaction [ Time Frame: 6 months ]
    measured by the Medication Satisfaction Questionnaire (MSQ)

  7. Employment, presentism and absenteeism [ Time Frame: 6 months ]
    assessed by the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03818399


Contacts
Layout table for location contacts
Contact: Lori Keyser-Marcus, PhD 804-828-4164 lori.keysermarcus@vcuhealth.org
Contact: Mary Bowman, NP 804-828-3686 mary.bowman@vcuhealth.org

Locations
Layout table for location information
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Indivior Inc.
Investigators
Layout table for investigator information
Principal Investigator: Frederick G Moeller, MD Virginia Commonwealth University

Layout table for additonal information
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03818399     History of Changes
Other Study ID Numbers: HM20014602
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists