Treatment With Acamprosate in Patients With Schizophrenia and Comorbid Alcoholism
Condition: Alcohol Dependence; Schizophrenia
MeSH terms: Alcoholism; Schizophrenia
Intervention: Acamprosate; Placebo
Intervention description: Acamprosate 1998 mg tid; Placebo
Intervention MeSH terms: Acamprosate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 23.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Treatment; Alcohol Dependence; Schizophrenia

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).
    

Eligibility 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.