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NCT03113409 · ClinicalTrials.gov registry record · Phase 2

Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol

A Phase 2 study, sponsored by New York State Psychiatric Institute.

Terminated
Registry status
Phase 2
Development phase
10
Enrollment target

NCT03113409: Clinical Trial Phase 2 study, sponsored by New York State Psychiatric Institute.

NCT03113409 is a Phase 2 study that was terminated before completion, run by New York State Psychiatric Institute. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03113409, a Phase 2 study, was terminated before completion, sponsored by New York State Psychiatric Institute.

TERMINATED
Registry status
Phase 2
Development phase
10 participants
Enrollment target

Study Summary

The study will enroll 30 opioid-dependent participants into an open-label pilot outpatient study of methods to facilitate induction and stabilization onto XR-NTX. There will be three different methods of XR-NTX induction using increasing doses of oral naltrexone and buprenophine.

Primary Outcome

Percentage of patient who initiated Procedure 1 and completed the study receiving the 2nd injection of XR-NTX

Interventions

  • DRUG Buprenorphine
  • DRUG Naltrexone
  • DRUG Vivitrol

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2017-06-01
Est. Completion 2020-12-01
Phase Phase 2

Why NCT03113409 stopped before completion

NCT03113409 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 3 interventions - of which Buprenorphine is the first listed.

NCT03113409 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03113409 about?

NCT03113409 is a clinical study titled "Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol". The study will enroll 30 opioid-dependent participants into an open-label pilot outpatient study of methods to facilitate induction and stabilization onto XR-NTX. There will be three different methods of XR-NTX induction using increasing doses of oral naltrexone and buprenophine.

What is the current status of trial NCT03113409?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2017-06-01. Estimated completion is 2020-12-01.

What interventions are being tested in trial NCT03113409?

The interventions under investigation include: Buprenorphine (DRUG), Naltrexone (DRUG), Vivitrol (DRUG).

Who is sponsoring clinical trial NCT03113409?

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 NCT03113409's enrollment target sits among peer trials

10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT03113409, the US trial registry maintained by the National Library of Medicine. NCT03113409 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.