CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 90 enrolled
Drug / intervention
Naltrexone or Placebodrug
Likely dose
Naltrexone or Placebo 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00145847
NCT00145847Phase 4Completed

Naltrexone Treatment of Alcohol Abuse in Schizophrenia

State University of New York - Upstate Medical University·interventional·Posted Sep 5, 2005·Updated Jan 8, 2013

In Brief

A Phase 4 clinical trial evaluating Naltrexone or Placebo for Schizophrenia and 4 related conditions. Completed, enrolled 90 participants across 4 sites.

Detailed Summary

The primary purpose of this study is to determine whether naltrexone is effective in the treatment of alcohol dependence and abuse in patients with schizophrenia and schizoaffective disorder. Hypotheses are as follows: hypothesis 1: Naltrexone will be more effective than placebo in reducing alcohol use. hypothesis 2: Patients responding to naltrexone by reducing alcohol use will also show reductions in severity of psychiatric symptoms and utilization of inpatient and emergency psychiatric services. hypothesis 3: Severity of psychiatric symptoms and amount of service utilization will correlate positively with alcohol use.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 5, 2005
Enrollment StartApr 1, 2003
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 20.8 years ago

Interventions

Naltrexone or Placebodrug

Naltrexone or Placebo 50 mg per day