CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 11 enrolled
Drug / intervention
Sublocadedrug
Likely dose
Sublocade 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03861338
NCT03861338Phase 2Completed
CompareCT.gov

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

New York State Psychiatric Institute·interventional·Posted Mar 4, 2019·Updated Mar 9, 2021

In Brief

A Phase 2 clinical trial evaluating Sublocade for Opioid-use Disorder. Completed, enrolled 11 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid-use Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMar 4, 2019
Enrollment StartMar 1, 2019
Primary CompletionFeb 28, 2020
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 7.3 years ago

Interventions

Sublocadedrug

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.