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COMPLETED Phase 4

Feasibility Study of Extended-release Naltrexone (Vivitrol) in Drug Court Settings

NCT02978417 · View on ClinicalTrials.gov ↗

Study Summary

In preparation for a large-scale randomized controlled trial (RCT) of Vivitrol® effectiveness in drug courts, investigators propose a feasibility study in the Wake County, North Carolina drug court, where an estimated 50% of clients are opioid dependent. Aim 1: Pilot RCT. Pilot-test the delivery of Vivitrol® treatment for 10-20 interested and eligible clients of the Wake County Drug Court.

Conditions Studied

Interventions

  • DRUG Naltrexone for extended-release injectable suspension
  • DRUG Oral naltrexone

Study Locations (1)

North Carolina

  • Fellowship Health Resources (FHR) — Raleigh

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2017-09-21
Est. Completion 2019-06-30
Phase Phase 4

Sponsor

Duke University

1,129 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02978417

The ClinicalTrials.gov registry entry for NCT02978417 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,129 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Opioid-Related Disorders appearing as the primary indexed condition, and to 2 interventions — of which Naltrexone for extended-release injectable suspension is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02978417 reports 1 study location spanning 1 distinct geographic area — top geographies include North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02978417 about?

NCT02978417 is a clinical study titled "Feasibility Study of Extended-release Naltrexone (Vivitrol) in Drug Court Settings". In preparation for a large-scale randomized controlled trial (RCT) of Vivitrol® effectiveness in drug courts, investigators propose a feasibility study in the Wake County, North Carolina drug court, where an estimated 50% of clients are opioid dependent. Aim 1: Pilot RCT. Pilot-test the delivery of...

What is the current status of trial NCT02978417?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 14 participants. The study started on 2017-09-21. Estimated completion is 2019-06-30.

What conditions does trial NCT02978417 study?

This clinical trial studies the following conditions: Opioid-Related Disorders. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02978417?

The interventions under investigation include: Naltrexone for extended-release injectable suspension (DRUG), Oral naltrexone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02978417?

This trial is sponsored by Duke University, which has 1,129 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02978417 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial