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NCT00577408 · ClinicalTrials.gov registry record · Phase 3
Behavioral Naltrexone Therapy for Promoting Adherence to Oral Naltrexone vs Extended Release Injectable Depot Naltrexone
A Phase 3 study of Opiate Dependence and Heroin Dependence, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 3
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT00577408 is a Phase 3 study of Opiate Dependence and Heroin Dependence that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 60 participants, below the 603-participant average among 15 other Opiate Dependence trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00577408, a Phase 3 study of Opiate Dependence and Heroin Dependence, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
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, categorized as Phase 3. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 603-participant average among 15 other Opiate Dependence trials with a reported enrollment target (90% lower). The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.
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.
NCT00577408 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
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.
What interventions are being tested in trial NCT00577408?
The interventions under investigation include: depot naltrexone (DRUG), Oral Naltrexone (DRUG).
Who is sponsoring clinical trial NCT00577408?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
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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