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Behavioral Naltrexone Therapy for Promoting Adherence to Oral Naltrexone vs Extended Release Injectable Depot Naltrexone
NCT00577408 · View on ClinicalTrials.gov ↗
Study Summary
In pilot study now proposed, we plan to randomly assign 60 opioid dependent patients to the new model, Depot-BNT, or to BNT plus oral naltrexone for a 6-month trial. This will provide initial clinical experience with the new Depot-BNT treatment model, while providing a rigorous test of whether Depot-BNT produces superior treatment outcome, compared to our best behavioral platform for oral naltrexone (BNT). The following aims will be addressed: Specific Aim #1: To test whether Depot-BNT increases retention in treatment and improves drug use outcome (urine-confirmed abstinent weeks) compared to our established model of BNT with oral naltrexone (BNT-Oral), and to explore whether Depot-BNT (vs BNT-Oral) improves key secondary outcomes including dysphoria, HIV risk behavior, and social functioning. Specific Aim #2: To explore predictors of outcome on Depot-BNT, and mechanisms of attrition, in order to optimize Depot-BNT prior to further testing.
Conditions Studied
Interventions
- DRUG depot naltrexone
- DRUG Oral Naltrexone
Study Locations (1)
New York
- New York State Psychiatric Institute — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2007-09 |
| Est. Completion | 2011-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00577408
The ClinicalTrials.gov registry entry for NCT00577408 describes a study currently listed as completed. It is categorized as Phase 3, 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 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 117 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Opiate Dependence appearing as the primary indexed condition, and to 2 interventions — of which depot naltrexone 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: NCT00577408 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. 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 NCT00577408 about?
NCT00577408 is a clinical study titled "Behavioral Naltrexone Therapy for Promoting Adherence to Oral Naltrexone vs Extended Release Injectable Depot Naltrexone". In pilot study now proposed, we plan to randomly assign 60 opioid dependent patients to the new model, Depot-BNT, or to BNT plus oral naltrexone for a 6-month trial. This will provide initial clinical experience with the new Depot-BNT treatment model, while providing a rigorous test of whether Depot...
What is the current status of trial NCT00577408?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 60 participants. The study started on 2007-09. Estimated completion is 2011-08.
What conditions does trial NCT00577408 study?
This clinical trial studies the following conditions: Opiate Dependence, Heroin Dependence. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00577408?
The interventions under investigation include: depot naltrexone (DRUG), Oral Naltrexone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00577408?
This trial is sponsored by New York State Psychiatric Institute, which has 117 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00577408 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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