Virginia Opioid Overdose Treatment InitiatVE (VOTIVE)
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|ClinicalTrials.gov Identifier: NCT03818399|
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : January 28, 2019
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|
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.
|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)|
|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|
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.
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.
- 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
- 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.
- 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)
- Illicit opioid use [ Time Frame: 6 months ]Illicit opioid use as measured by urine drug screen (UDS) results.
- 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
- 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
- Treatment effectiveness and employment [ Time Frame: 6 months ]Treatment effectiveness as measured by Treatment Effectiveness Assessment (TEA)
- Medication satisfaction [ Time Frame: 6 months ]measured by the Medication Satisfaction Questionnaire (MSQ)
- Employment, presentism and absenteeism [ Time Frame: 6 months ]assessed by the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP)
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
|Contact: Lori Keyser-Marcus, PhDfirstname.lastname@example.org|
|Contact: Mary Bowman, NPemail@example.com|
|United States, Virginia|
|Virginia Commonwealth University||Recruiting|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Frederick G Moeller, MD||Virginia Commonwealth University|