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Treatment With Acamprosate in Patients With Schizophrenia and Comorbid Alcoholism

Primary Purpose

Alcohol Dependence, Schizophrenia

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Acamprosate

Placebo

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring Treatment, Alcohol Dependence, Schizophrenia

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

VA Connecticut Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Acamprosate

placebo

Arm Description

Acamprosate

placebo

Outcomes

Primary Outcome Measures

Number of Drinking Days

Psychotic Symptoms - Measured Using the PANSS

The PANSS or the Positive and Negative Syndrome Scale is a medical scale used for measuring symptom severity of patients with schizophrenia. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. Of the 30 items included in the PANSS, 7 constitute a Positive Scale, 7 a Negative Scale, and the remaining 16 a General Psychopathology Scale.The scores for these scales are arrived at by summation of ratings across component items. Therefore, the potential ranges are 7 to 49 for the Positive and Negative Scales, and 16 to 112 for the General Psychopathology Scale. A higher score indicates more severe symptoms.

Secondary Outcome Measures

Full Information

NCT ID

NCT00463346

First Posted

April 18, 2007

Last Updated

March 27, 2020

Sponsor

Yale University

Collaborators

Forest Laboratories

1. Study Identification

Unique Protocol Identification Number

NCT00463346

Brief Title

Treatment With Acamprosate in Patients With Schizophrenia and Comorbid Alcoholism

Official Title

Treatment With Acamprosate in Patients With Schizophrenia and Comorbid Alcoholism

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

Forest Laboratories

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Dependence, Schizophrenia

Keywords

Treatment, Alcohol Dependence, Schizophrenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acamprosate

Arm Type

Experimental

Arm Description

Acamprosate

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

placebo

Intervention Type

Drug

Intervention Name(s)

Acamprosate

Other Intervention Name(s)

Campral

Intervention Description

Acamprosate 1998 mg tid

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Number of Drinking Days

Time Frame

12 weeks

Title

Psychotic Symptoms - Measured Using the PANSS

Description

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ismene L Petrakis, MD

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA Connecticut Healthcare System

City

West Haven

State/Province

Connecticut

ZIP/Postal Code

06516

Country

United States

12. IPD Sharing Statement

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Treatment With Acamprosate in Patients With Schizophrenia and Comorbid Alcoholism

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