Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00463346
Status:
COMPLETED
Last Update Posted:
2020-03-31
First Post:
2007-04-18
Brief Title:
Treatment With Acamprosate in Patients With Schizophrenia and Comorbid Alcoholism
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Treatment With Acamprosate in Patients With Schizophrenia and Comorbid Alcoholism
Status:
COMPLETED
Status Verified Date:
2015-12
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 aim of this study is to evaluate the safety and efficacy of acamprosate for patients with alcohol dependence and comorbid schizophrenia spectrum disorders
1 Relative to placebo acamprosate will significantly increase cumulative days of abstinence in recently detoxified alcohol dependent schizophrenia patients measured by Timeline Follow-Back TLFB method
2 Acamprosate will have no significant effect on the psychotic symptoms in schizophrenia patients with alcohol dependence as measured by the Positive and Negative Syndrome Scale PANSS
1 Relative to placebo acamprosate will significantly increase cumulative days of abstinence in recently detoxified alcohol dependent schizophrenia patients measured by Timeline Follow-Back TLFB method
2 Acamprosate will have no significant effect on the psychotic symptoms in schizophrenia patients with alcohol dependence as measured by the Positive and Negative Syndrome Scale PANSS
Detailed Description:
Alcohol use disorders AUD are common comorbid conditions in patients with schizophrenia and they cause a negative impact on the expression and course of schizophrenia Improvements have been reported after attaining abstinence from alcohol suggesting that effective treatments for AUD lead to clinically meaningful results Acamprosate is a recently approved treatment for alcoholism and it may be advantageous over other treatments since is not metabolized in the liver and it has been used safely with other psychotropic medications Therefore acamprosate would be a promising treatment in schizophrenia patients However there are only few reports in the current literature evaluating the efficacy of medications available for the treatment of alcoholism in patients with schizophrenia and the efficacy and safety of acamprosate have never been studied in this vulnerable group of patients
Research Design
This is a 12-week randomized double blind placebo controlled trial of acamprosate 666 mg tid in addition to neuroleptics in 30 recently abstinent 5 days schizophrenia patients with comorbid alcohol dependence
Methods
The study will be conducted at the West Haven CT VA with support from Forest Laboratories Patients who are between 21 and 65 with a diagnosis of schizophrenia spectrum disorder on stable psychotropic treatment 2 weeks and with current alcohol dependence 1 recent episode of heavy drinking will be included Patients will be willing to undergo detoxification or self discontinuation 2weeks prior to the randomization Main outcome variables include the TLFB method to document the degree of daily alcohol consumption and PANSS to assess the psychotic symptoms
Research Design
This is a 12-week randomized double blind placebo controlled trial of acamprosate 666 mg tid in addition to neuroleptics in 30 recently abstinent 5 days schizophrenia patients with comorbid alcohol dependence
Methods
The study will be conducted at the West Haven CT VA with support from Forest Laboratories Patients who are between 21 and 65 with a diagnosis of schizophrenia spectrum disorder on stable psychotropic treatment 2 weeks and with current alcohol dependence 1 recent episode of heavy drinking will be included Patients will be willing to undergo detoxification or self discontinuation 2weeks prior to the randomization Main outcome variables include the TLFB method to document the degree of daily alcohol consumption and PANSS to assess the psychotic symptoms
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 |
|---|---|---|---|
| IP00027 | None | None | None |
| 0607001674 | None | None | None |