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NCT00453609 · ClinicalTrials.gov registry record · Phase 4
Injectable Naltrexone Treatment of Alcohol Dependence in Serious Mental Illness (SMI)
A Phase 4 study, sponsored by State University of New York - Upstate Medical University.
- Completed
- Registry status
- Phase 4
- Development phase
- 15
- Enrollment target
NCT00453609: Completed Phase 4 study, sponsored by State University of New York - Upstate Medical University.
NCT00453609 is a Phase 4 study that has completed, run by State University of New York - Upstate Medical University. The registered enrollment target is 15 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00453609, a Phase 4 study, has completed, sponsored by State University of New York - Upstate Medical University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 15 participants
- Enrollment target
Study Summary
The overall goal of this project is to improve the treatment of alcohol dependence in patients with serious mental illness (SMI). SMI for this study is defined as any patient with any of the following diagnoses: schizophrenia, schizoaffective disorder, and bipolar type I or type II disorder. Alcohol and other substance use disorders (SUDs) are common among individuals with SMI. SUD comorbidity is associated with many adverse consequences. However, to date, few reports have addressed the efficacy of pharmacological treatments for SUDs in this population. Naltrexone pharmacotherapy is an effective treatment for alcohol dependence, but it has not been systematically applied to the care of patients with SMI. The primary aim of this study is to determine the feasibility of long-acting injectable naltrexone administration in a clinical trial in patients with SMI who also have a diagnosis of alcohol dependence. Secondary aims include providing a preliminary assessment of the tolerability and safety of long-acting injectable naltrexone in patients with SMI who also have a diagnosis of alcohol dependence. An additional aim is to provide a preliminary assessment of the efficacy of long-acting injectable naltrexone in reducing alcohol use from baseline levels.
Interventions
- DRUG long-lasting injectable naltrexone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2007-04 |
| Est. Completion | 2008-10 |
| Phase | Phase 4 |
What the finished NCT00453609 record still lists
NCT00453609 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which long-lasting injectable naltrexone is the first listed.
NCT00453609 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00453609 about?
NCT00453609 is a clinical study titled "Injectable Naltrexone Treatment of Alcohol Dependence in Serious Mental Illness (SMI)". The overall goal of this project is to improve the treatment of alcohol dependence in patients with serious mental illness (SMI). SMI for this study is defined as any patient with any of the following diagnoses: schizophrenia, schizoaffective disorder, and bipolar type I or type II disorder. Alcohol...
What is the current status of trial NCT00453609?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2007-04. Estimated completion is 2008-10.
What interventions are being tested in trial NCT00453609?
The interventions under investigation include: long-lasting injectable naltrexone (DRUG).
Who is sponsoring clinical trial NCT00453609?
This trial is sponsored by State University of New York - Upstate Medical University, which has 113 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00453609's enrollment target sits among peer trials
15 1880th of 2000 higher than 100 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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