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NCT01180647 · ClinicalTrials.gov registry record · Phase 3

Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail

A Phase 3 study, sponsored by NYU Langone Health.

Completed
Registry status
Phase 3
Development phase
48
Enrollment target

NCT01180647: Completed Phase 3 study, sponsored by NYU Langone Health.

NCT01180647 is a Phase 3 study that has completed, run by NYU Langone Health. The registered enrollment target is 48 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01180647, a Phase 3 study, has completed, sponsored by NYU Langone Health.

COMPLETED
Registry status
Phase 3
Development phase
48 participants
Enrollment target

Study Summary

This pilot study's primary aim is to compare rates of sustained opioid relapse, defined as self-reported opioid use \>50% (\>15 of 30) of days during the first 30 days following release from jail, among persons treated with XR-NTX pre-release vs. controls not receiving XR-NTX.

Primary Outcome

Post-release opioid relapse at week 4, measured by self-report (Time Line Follow Back) and urine toxicologies, and defined as ≥10 of 28 days of self-reported opioid misuse following jail release or two or three positive of the three urine samples during weeks 2, 3 and 4. A single positive or missing urine result counted as 7 opioid misuse days.

Interventions

  • DRUG Extended-Release Naltrexone
  • BEHAVIORAL Motivational Enhancement Counseling

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2010-05
Est. Completion 2013-07
Phase Phase 3
NYU Langone Health

1,164 total trials

What the finished NCT01180647 record still lists

NCT01180647 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).

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

NCT01180647 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01180647 about?

NCT01180647 is a clinical study titled "Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail". This pilot study's primary aim is to compare rates of sustained opioid relapse, defined as self-reported opioid use \>50% (\>15 of 30) of days during the first 30 days following release from jail, among persons treated with XR-NTX pre-release vs. controls not receiving XR-NTX.

What is the current status of trial NCT01180647?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 48 participants. The study started on 2010-05. Estimated completion is 2013-07.

What interventions are being tested in trial NCT01180647?

The interventions under investigation include: Extended-Release Naltrexone (DRUG), Motivational Enhancement Counseling (BEHAVIORAL).

Who is sponsoring clinical trial NCT01180647?

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 NCT01180647's enrollment target sits among peer trials

48 1862nd of 2000 higher than 134 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT01180647, the US trial registry maintained by the National Library of Medicine. NCT01180647 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.