Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145847
Status:
COMPLETED
Last Update Posted:
2013-01-08
First Post:
2005-09-01
Brief Title:
Naltrexone Treatment of Alcohol Abuse in Schizophrenia
Sponsor:
State University of New York - Upstate Medical University
Organization:
State University of New York - Upstate Medical University
Study Overview
Official Title:
Naltrexone Treatment of Alcohol Abuse in Schizophrenia
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
The long-term goal of the proposed project is to improve the treatment of alcohol abuse and dependence in patients with schizophrenia and schizoaffective disorder Alcohol use disorders are common among patients with severe mental illness It is estimated that there may be as many as 750000 individuals in the United States with comorbid schizophrenia and alcohol disorders Alcohol disorder comorbidity requires treatment because it is associated with adverse consequences such as increased rates of hospitalization Yet to date there are no reports of controlled trials testing the efficacy of pharmacological treatments for alcohol abuse or dependence 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 schizophrenia The specific aims of this study are To test the efficacy of naltrexone in reducing alcohol use among individuals with schizophrenia and schizoaffective disorder who also have alcohol abuse or dependence We will test hypothesis 1 Naltrexone will be more effective than placebo in reducing alcohol use Our primary outcome measure will be the number of drinking days over the course of the treatment trial To test naltrexones efficacy in reducing psychiatric symptom severity and medical utilization by reducing alcohol use We will test 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 To determine the relationship between a changes in alcohol use and b psychiatric symptom severity and inpatient and emergency service utilization We will test hypothesis 3 Severity of psychiatric symptoms and amount of service utilization will correlate positively with alcohol use The proposed research will study a cohort of 150 subjects in a double-blind randomized placebo-controlled trial of naltrexone using three times per week directly observed administration of medication The study will be 6 months in duration consisting of a 12-week course of naltrexone or placebo plus 3 monthly follow-up interviews after discontinuation of medication Voucher incentives contingent on attendance will be provided to all subjects to ensure attendance for medication administration Weekly motivational enhancement counseling sessions will also be provided to all subjects Study outcomes will consist of self-report and biological measures of alcohol use as well as measures of psychiatric symptom severity and medical service utilization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01AA013655-01A1 | NIH | None | httpsreporternihgovquickSearch1R01AA013655-01A1 |