Clinical trial NCT00463346: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alcohol Dependence
Schizophrenia
Keywords: Treatment
Alcohol Dependence
Schizophrenia
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2007-04-20
Enrollment: 23
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Drinking Days
timeFrame: 12 weeks
measure: Psychotic Symptoms - Measured Using the PANSS
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: Yale University
name: Ismene L Petrakis, MD
role: PRINCIPAL_INVESTIGATOR
References: