Treatment With Acamprosate in Patients With Schizophrenia and Comorbid Alcoholism

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Elizabeth Ralevski, Yale University
ClinicalTrials.gov Identifier:
NCT00463346
First received: April 18, 2007
Last updated: June 13, 2014
Last verified: June 2014
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Treatment With Acamprosate in Patients With Schizophrenia and Comorbid Alcoholism

Resource links provided by NLM:


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 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: acamprosate
    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

  1. Men and women between 21 and 65 years of age.
  2. 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].
  3. Patients who are on stable treatment with psychotropic medication > 2 weeks prior to randomization.
  4. 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).
  5. Patients, who are able to comprehend and satisfactorily comply with protocol requirements.
  6. Patients who have capacity to provide informed consent prior to entering any study procedure.

Exclusion Criteria

  1. Patients with dementia, amnestic and other cognitive disorders.
  2. 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
  3. Patients with a history of opioid dependence within the past month.
  4. Patients with a history of intolerance or hypersensitivity to acamprosate.
  5. Patients who are currently taking disulfiram or naltrexone.
  6. Patients who based on history or mental status examination are at a significant risk for suicide.
  7. Patients who are homicidal or violent and who are in the Investigator's opinion in significant imminent risk of hurting others.
  8. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Connecticut
VA Connecticut Healthcare System
WEst Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Elizabeth Ralevski
Forest Laboratories
Investigators
Principal Investigator: Ismene L Petrakis, MD Yale University
  More Information

No publications provided

Responsible Party: Elizabeth Ralevski, Assistant Professor, Yale University
ClinicalTrials.gov Identifier: NCT00463346     History of Changes
Other Study ID Numbers: CMP-MD-13, 0607001674, IP00027
Study First Received: April 18, 2007
Last Updated: June 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Treatment
Alcohol Dependence
Schizophrenia

Additional relevant MeSH terms:
Alcoholism
Schizophrenia
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Acamprosate
Alcohol Deterrents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014