Treatment With Acamprosate in Patients With Schizophrenia and Comorbid Alcoholism

What is the purpose of this trial?

Who can participate?

Ages Eligible: 21 Years - 65 Years
Gender Eligible: Both

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.

What is the purpose of this trial?

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Who can participate?

Ages Eligible: 21 Years - 65 Years
Gender Eligible: Both

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.

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Additional Location

Connecticut