NCT03861338

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid-use Disorder

Interventions

Type	Name	Description
DRUG	Sublocade	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.

Timeline

• Start date: 2019-03-01
• Primary completion: 2020-02-28
• Completion: 2020-02-28
• First posted: 2019-03-04
• Last updated: 2021-03-09
• Results posted: 2021-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study