Treatment With Acamprosate in Patients With Schizophrenia and Comorbid Alcoholism - Full Text View

Sponsors and Collaborators:	Yale University Forest Laboratories
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00463346

Purpose

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).

Condition	Intervention	Phase
Alcohol Dependence Schizophrenia	Drug: acamprosate	Phase III

MedlinePlus related topics: Alcoholism Psychotic Disorders Schizophrenia

Drug Information available for: Acamprosate Acamprosate calcium Ethanol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Treatment With Acamprosate in Patients With Schizophrenia and Comorbid Alcoholism

Further study details as provided by Yale University:

Primary Outcome Measures:

drinking - measured using the TLFB [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
craving - measured using the OCDS [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
psychotic symptoms - measured using the PANSS [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

cognitive functioning [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
psychiatric distress [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	September 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Intervention Details:

acamprosate 1998mg/day

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.

Eligibility

Ages Eligible for Study:	21 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Men and women between 21 and 65 years of age.
Patients with a diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder NOS as determined by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID) [22].
Patients who are on stable treatment with psychotropic medication > 2 weeks prior to randomization.
Patients with current alcohol dependence, with at least one recent episode of heavy drinking (defined as 5 or more drinks per drinking episode) over the past 21 days, and willing to undergo detoxification or self discontinuation (for at least 5 days).
Patients, who are able to comprehend and satisfactorily comply with protocol requirements.
Patients who have capacity to provide informed consent prior to entering any study procedure.

Exclusion Criteria

Patients with dementia, amnestic and other cognitive disorders.
Patients who have unstable medical disease or a medical condition that, in the Investigator's opinion, would expose them to an increased risk of a significant adverse event or interfere with assessments of safety and efficacy during the course of the trial
Patients with a history of opioid dependence within the past month.
Patients with a history of intolerance or hypersensitivity to acamprosate.
Patients who are currently taking disulfiram or naltrexone.
Patients who based on history or mental status examination are at a significant risk for suicide.
Patients who are homicidal or violent and who are in the Investigator's opinion in significant imminent risk of hurting others.
Women who are pregnant or nursing, or women of childbearing potential who are sexually active and who do not use adequate contraception, or who are judged to be unreliable in their use of contraception.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463346

Contacts

Contact: Elizabeth Ralevski, Ph.D.

203-932-5711 ext 4282

elizabeth.ralevski@yale.edu

Locations

United States, Connecticut
VA Connecticut Healthcare System	Recruiting
WEst Haven, Connecticut, United States, 06516
Principal Investigator: Ismene L Petrakis, MD

Sponsors and Collaborators

Yale University

Forest Laboratories

Investigators

Principal Investigator:

Ismene L Petrakis, MD

Yale University

More Information

Responsible Party:	Yale University ( Ismene Petrakis )
Study ID Numbers:	CMP-MD-13, 0607001674, IP00027
Study First Received:	April 18, 2007
Last Updated:	August 28, 2008
ClinicalTrials.gov Identifier:	NCT00463346
Health Authority:	United States: Institutional Review Board

Keywords provided by Yale University:

Treatment
Alcohol Dependence
Schizophrenia

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Alcoholism
Substance-Related Disorders
Disorders of Environmental Origin

Psychotic Disorders
Alcohol-Related Disorders
Schizophrenia and Disorders with Psychotic Features
Acamprosate
Ethanol

Additional relevant MeSH terms:

Therapeutic Uses
Central Nervous System Agents
Pharmacologic Actions
Alcohol Deterrents

ClinicalTrials.gov processed this record on January 16, 2009