Clinical trial NCT03861338
Conditions: Opioid-use Disorder
Keywords: opioid use disorder, sublocade, buprenorphine
Sponsor: New York State Psychiatric Institute
Start date: 2019-03-01; Completion date: 2020-02-28
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The proposed study is a 12-week, open-label pilot study of sublocade (extended-release burprenorphine, BXR) as treatment for opiate use disorder (OUD) testing positive for Highly Potent Synthetic Opioids (HPSO). The investigators plan to enroll 10 participants into the study.

Detailed description:
This is an open-label, uncontrolled pilot study. Outpatients seeking treatment for Opiate Use Disorder (OUD) will be screened, and those eligible who are positive for fentanyl analogues at screening will be consented and inducted onto sublingual buprenorphine (target dose 16mg to 24mg). On the fourth day after starting the buprenorphine induction, participants will receive sublocade (BXR) 300mg by subcutaneious injection. Participants will be seen twice per week for urine collection for toxicology and research assessments and will have Medication Management counseling weekly during one of these visits. BXR will be administered monthly and dosing will be according to the FDA prescribing instructions of 300mg for the second dose and 100mg for the third.

Arms: arm 1: Sublocade buprenorphine extended-release (BXR) injection, 300 mg and 100 mg
Interventions: intervention 1: Sublocade
Intervention descriptions: intervention 1: The monthly Sublocade buprenorphine extended-release (BXR) injection will be administered in two doses (100 mg and 300 mg). Following a 4 day induction onto oral buprenorphine, the first 300 mg injection of Sublocade will be administered. A second 300 mg Sublocade injection will be administered 1 month later and the third and final monthly injection of 100 mg of Sublocade will be administered 2 months post the successful buprenorphine induction.

Protocol documents:
Prot_000.pdf: 
 
 
 
 
 
 
Study: # 7764 entitled An Open-Label Pilot Study of Sublocade as Treatment for Opiate Use 
Disorder 
 
PI: John Mariani, MD 
NCT# NCT03861338 
Protocol approved: 2-27-2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 











































SAP_001.pdf: 
 
 
 
 
 
 
Study: # 7764 entitled An Open-Label Pilot Study of Sublocade as Treatment for Opiate Use 
Disorder 
 
PI: John Mariani, MD 
NCT# NCT03861338 
Data Analysis Plan created 2-25-2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
2 
C. DATA MANAGEMENT AND ANALYSIS 
C1. Data Acquisition and Transmission 
All data will be obtained specifically for research purposes. Data will be entered into an Excel spreadsheet 
coded with a unique identifier assigned to each participant. Departmental, HIPAA-compliant Research 
Subject Registration System, will however contain participants’ names.  
C2. Data Entry Methods  
As noted above, data will be entered into an Excel spreadsheet. Data management will include: 1) protocol 
management; 2) patient scheduling; 3) regulatory reporting and 4) management of research organizations, 
personnel, and collaborators. The research staff will collect and input data on a daily, basis to reduce the 
likelihood of errors. Information collection and analysis and study-specific data collection will be easily 
retrievable, organized, and reviewed on an ongoing basis as well. 
C3. Data Analysis Plan 
Overview of Data Analytic Plan 
Sample size: A total of 10 participants will be recruited. 
A total of 10 patients will be recruited over a 6-month period. The main analyses in this study will be on the 
intent-to-treat (ITT) sample, i.e. on all enrolled patients who receive study medication, and all tests will be 
two-sided, performed at significance α=0.05, except where noted. Before specific statistical techniques are 
applied in order to test the hypotheses of interest, we will examine all variables at all time points for outliers. 
The distributions of all continuous variables will be checked for normality, and transformations will be 
employed, if necessary, before applying specific parametric techniques. 
 
Hypotheses testing: 
Primary Outcome: The proportion of participants successfully inducted onto BXR. 
Secondary Outcomes: BXR treatment will be associated with decreased opioid use for OUD patients positive 
for HPSO. The primary outcome measure will be opioid use during the last two weeks of the study compared 
to baseline as measured by a combination of urine toxicology and self-report. BXR injection will be 
associated with reduce symptoms of craving and symptoms of withdrawal as compared to baseline.