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NCT03861338 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by New York State Psychiatric Institute.

Completed
Registry status
Phase 1
Development phase
11
Enrollment target

NCT03861338: Completed Phase 1 study, sponsored by New York State Psychiatric Institute.

NCT03861338 is a Phase 1 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03861338, a Phase 1 study, has completed, sponsored by New York State Psychiatric Institute.

COMPLETED
Registry status
Phase 1
Development phase
11 participants
Enrollment target

Study 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.

Primary Outcome

Number of participants successfully inducted onto Sublocade (BXR)

Interventions

  • DRUG Sublocade

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2019-03-01
Est. Completion 2020-02-28
Phase Phase 1

What the finished NCT03861338 record still lists

NCT03861338 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).

The record links to 0 conditions, and to 1 intervention - of which Sublocade is the first listed.

NCT03861338 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03861338 about?

NCT03861338 is a clinical study titled "An Open-Label Pilot Study of Sublocade as Treatment for Opiate Use Disorder". 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.

What is the current status of trial NCT03861338?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2019-03-01. Estimated completion is 2020-02-28.

What interventions are being tested in trial NCT03861338?

The interventions under investigation include: Sublocade (DRUG).

Who is sponsoring clinical trial NCT03861338?

This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03861338's enrollment target sits among peer trials

11 1911th of 2000 higher than 88 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03861338, the US trial registry maintained by the National Library of Medicine. NCT03861338 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.