Treatment With Acamprosate in Patients With Schizophrenia and Comorbid Alcoholism

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: Forest Laboratories
• Treatments: Acamprosate

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.