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ACTIVE NOT RECRUITING Phase 2

Extended Release Naltrexone Versus Extended Release Buprenorphine With Individuals Leaving Jail

NCT04408313 · View on ClinicalTrials.gov ↗

Study Summary

The proposed study is a Type 1 hybrid effectiveness-implementation trial. Individuals with opioid use disorder in county jails throughout the state of Maryland will be randomly assigned within gender within jail to one of two groups: Arm 1. XR-B (n=120). XR-B in jail followed by 6 monthly injections post-release at a community treatment program. Arm 2. XR-NTX (n=120). One injection of XR-NTX in jail, followed by 6 monthly injections post-release at a community treatment program.

Conditions Studied

Interventions

  • DRUG XR-B
  • DRUG XR-NTX

Study Locations (1)

Maryland

  • Friends Research Institute — Baltimore

Trial Details

FieldValue
Enrollment Target 240 participants
Start Date 2020-10-28
Est. Completion 2026-05-31
Phase Phase 2

Sponsor

Friends Research Institute

19 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04408313

The ClinicalTrials.gov registry entry for NCT04408313 describes a study currently listed as active not recruiting. It is categorized as Phase 2, 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 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Friends Research Institute, which has 19 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-use Disorder appearing as the primary indexed condition, and to 2 interventions — of which XR-B 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: NCT04408313 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. 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 NCT04408313 about?

NCT04408313 is a clinical study titled "Extended Release Naltrexone Versus Extended Release Buprenorphine With Individuals Leaving Jail". The proposed study is a Type 1 hybrid effectiveness-implementation trial. Individuals with opioid use disorder in county jails throughout the state of Maryland will be randomly assigned within gender within jail to one of two groups: Arm 1. XR-B (n=120). XR-B in jail followed by 6 monthly injections...

What is the current status of trial NCT04408313?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 240 participants. The study started on 2020-10-28. Estimated completion is 2026-05-31.

What conditions does trial NCT04408313 study?

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

What interventions are being tested in trial NCT04408313?

The interventions under investigation include: XR-B (DRUG), XR-NTX (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04408313?

This trial is sponsored by Friends Research Institute, which has 19 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04408313 being conducted?

This trial has 1 study location across Maryland. 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