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An Open-Label Pilot Study of Sublocade as Treatment for Opiate Use Disorder

Opioid-use Disorder Clinical Trial

Official title:
An Open-Label Pilot Study of Sublocade as Treatment for Opiate Use Disorder

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03861338
Study type Interventional
Source New York State Psychiatric Institute
Contact
Status Completed
Phase Phase 1/Phase 2
Start date March 1, 2019
Completion date February 28, 2020
View Details
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