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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: Completed Phase 3 study of Opiate Dependence and Heroin Dependence, sponsored by New York State Psychiatric Institute.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
compliance with being retained in treatment protocol
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 |
What the finished NCT00577408 record still lists
NCT00577408 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 603-participant average among 15 other Opiate Dependence trials with a reported enrollment target (90% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT00577408's enrollment target sits among peer trials
60 9th of 15 higher than 7 of 15 other Opiate Dependence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opiate Dependence 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.
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