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NCT00453804 · ClinicalTrials.gov registry record · Phase 4
Injectable Versus Oral 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
NCT00453804 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.
The verdict
NCT00453804, 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 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 as compared with oral 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 as compared with oral naltrexone in reducing alcohol use from baseline levels
Interventions
- DRUG oral naltrexone
- DRUG injectable naltrexone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2006-07 |
| Est. Completion | 2007-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00453804
The ClinicalTrials.gov registry entry for NCT00453804 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is State University of New York - Upstate Medical University, which has 113 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which oral naltrexone is the first listed.
NCT00453804 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00453804 about?
NCT00453804 is a clinical study titled "Injectable Versus Oral Naltrexone Treatment of Alcohol Dependence In Serious Mental Illness (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...
What is the current status of trial NCT00453804?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2006-07. Estimated completion is 2007-06.
What interventions are being tested in trial NCT00453804?
The interventions under investigation include: oral naltrexone (DRUG), injectable naltrexone (DRUG).
Who is sponsoring clinical trial NCT00453804?
This trial is sponsored by State University of New York - Upstate Medical University, which has 113 total clinical trials registered on ClinicalTrials.gov.
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