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

NCT03861338 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2021-03-09

Study results available
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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.

Conditions

  • Opioid-use Disorder

Interventions

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.

Sponsors & Collaborators

  • New York State Psychiatric Institute

    lead OTHER

Principal Investigators

  • John Mariani, MD · New York Psychiatric Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2020-02-28
Completion
2020-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03861338 on ClinicalTrials.gov