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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.

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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

FieldValue
Enrollment Target 15 participants
Start Date 2006-07
Est. Completion 2007-06
Phase Phase 4

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.