Trial Outcomes & Findings for Virginia Opioid Overdose Treatment InitiatVE (NCT NCT03818399)

NCT ID: NCT03818399

Last Updated: 2022-05-05

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 19 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2022-05-05

Participant Flow

Participant milestones

Measure	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: 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.
Overall Study STARTED	19
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Measure	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: 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.
Overall Study Lost to Follow-up	11
Overall Study Withdrawal by Subject	1
Overall Study Protocol Violation	2

Baseline Characteristics

Virginia Opioid Overdose Treatment InitiatVE

Baseline characteristics by cohort

Measure	Overdose Patients n=19 Participants 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: 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.
Age, Continuous	46.4 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Because repeat OD or opioid-related death is measured from electronic medical records and state death registries, data was collected on all participants even if they did not complete the study

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

Outcome measures

Measure	Overdose Patients n=19 Participants 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: 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.
Number of Repeat OD or Opioid-related Death Prevalence of repeat opioid-related overdose	0 Participants
Number of Repeat OD or Opioid-related Death Prevalence opioid-related death	0 Participants

SECONDARY outcome

Timeframe: 3 and 6 months

Population: An intent to treat model was used so data from all participants, even those who did not complete, was analyzed

Treatment engagement as measured by number of outpatient clinic visits (attendance), receipt of SUBLOCADE injections (buprenorphine treatment) at 3 and 6 months.

Outcome measures

Measure	Overdose Patients n=19 Participants 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: 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.
Treatment Engagement 3 months	8.1 visits Standard Deviation 7.72
Treatment Engagement 6 months	13.3 visits Standard Deviation 9.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 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)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Illicit opioid use as measured by urine drug screen (UDS) results.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Number of participants with mu opioid receptor polymorphisms associated with repeat overdose and death history of OD in subjects

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Treatment effectiveness as measured by Treatment Effectiveness Assessment (TEA)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

measured by the Medication Satisfaction Questionnaire (MSQ)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

assessed by the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP)

Outcome measures

Outcome data not reported

Adverse Events

Overdose Patients

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	Overdose Patients n=19 participants at risk 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: 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.
Psychiatric disorders Inpatient psychiatric treatment for schizoaffective disorder	5.3% 1/19 • Number of events 1 • 6 months
Infections and infestations Osteomyelitis	5.3% 1/19 • Number of events 1 • 6 months

Other adverse events

Measure	Overdose Patients n=19 participants at risk 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: 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.
Cardiac disorders Heart flutter	5.3% 1/19 • Number of events 1 • 6 months
Cardiac disorders Lower extremity edema	5.3% 1/19 • Number of events 1 • 6 months
General disorders Reduced appetite	5.3% 1/19 • Number of events 1 • 6 months
Nervous system disorders Drowsiness	5.3% 1/19 • Number of events 1 • 6 months
Skin and subcutaneous tissue disorders Inflammation at injection site	5.3% 1/19 • Number of events 1 • 6 months
Skin and subcutaneous tissue disorders Lip abscess	5.3% 1/19 • Number of events 1 • 6 months
Skin and subcutaneous tissue disorders Maculopapular rash	5.3% 1/19 • Number of events 1 • 6 months
Gastrointestinal disorders Constipation	21.1% 4/19 • Number of events 6 • 6 months
Gastrointestinal disorders Nausea	5.3% 1/19 • Number of events 1 • 6 months
Musculoskeletal and connective tissue disorders Leg muscle cramps after fall	5.3% 1/19 • Number of events 1 • 6 months
Musculoskeletal and connective tissue disorders Acute neck strain	5.3% 1/19 • Number of events 1 • 6 months
Eye disorders Eye pain	5.3% 1/19 • Number of events 1 • 6 months
Nervous system disorders Injection site pain	15.8% 3/19 • Number of events 5 • 6 months
Nervous system disorders Acute back pain from moving	5.3% 1/19 • Number of events 1 • 6 months
Nervous system disorders Chronic back pain	5.3% 1/19 • Number of events 1 • 6 months
Nervous system disorders Chronic neck pain associated with arthritis	5.3% 1/19 • Number of events 1 • 6 months
Nervous system disorders Acute left knee pain with comorbid arthritis	5.3% 1/19 • Number of events 1 • 6 months
General disorders Sedation	5.3% 1/19 • Number of events 1 • 6 months
General disorders Withdrawal symptoms	5.3% 1/19 • Number of events 1 • 6 months

Additional Information

Roy Sabo, PhD

Virginia Commonwealth University

Phone: 804-828-3047

Email: roy.sabo@vcuhealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place