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NCT03604159 · ClinicalTrials.gov registry record · Phase 4

XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept

A Phase 4 study, sponsored by NYU Langone Health.

Completed
Registry status
Phase 4
Development phase
52
Enrollment target

NCT03604159: Completed Phase 4 study, sponsored by NYU Langone Health.

NCT03604159 is a Phase 4 study that has completed, run by NYU Langone Health. The registered enrollment target is 52 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03604159, a Phase 4 study, has completed, sponsored by NYU Langone Health.

COMPLETED
Registry status
Phase 4
Development phase
52 participants
Enrollment target

Study Summary

This is a pilot proof-of-concept randomized controlled trial, open-label and unblinded, examining the feasibility and acceptability of Buprenorphine extended-release vs. daily sublingual buprenorphine-naloxone for the treatment of opioid use disorder in jail and at community re-entry.

Primary Outcome

Retained on any form of community buprenorphine treatment at Week 8

Interventions

  • DRUG Buprenorphine Extended Release
  • DRUG Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2019-06-24
Est. Completion 2020-05-04
Phase Phase 4
NYU Langone Health

1,164 total trials

What the finished NCT03604159 record still lists

NCT03604159 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 2 interventions - of which Buprenorphine Extended Release is the first listed.

NCT03604159 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03604159 about?

NCT03604159 is a clinical study titled "XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept". This is a pilot proof-of-concept randomized controlled trial, open-label and unblinded, examining the feasibility and acceptability of Buprenorphine extended-release vs. daily sublingual buprenorphine-naloxone for the treatment of opioid use disorder in jail and at community re-entry.

What is the current status of trial NCT03604159?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 52 participants. The study started on 2019-06-24. Estimated completion is 2020-05-04.

What interventions are being tested in trial NCT03604159?

The interventions under investigation include: Buprenorphine Extended Release (DRUG), Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets) (DRUG).

Who is sponsoring clinical trial NCT03604159?

This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03604159's enrollment target sits among peer trials

52 1233rd of 2000 higher than 752 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT03604159, the US trial registry maintained by the National Library of Medicine. NCT03604159 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.