OBJECTIVE: Alcohol abuse in patients with schizophrenia is associated with psychiatric and social complications. While two medications have been approved by the Federal Drug Administration (FDA) for the treatment of alcoholism: disulfiram and naltrexone, no medications have been approved for individuals with alcohol dependence and comorbid schizophrenia. The purpose of this study was to evaluate the efficacy of naltrexone in alcohol-abusing schizophrenic patients. METHOD:Thirty-one patients with schizophrenia and comorbid alcohol abuse or dependence were treated for 12 weeks in an outpatient study usingnaltrexone or placebo in a randomized, double-blind fashion in addition to their neuroleptic medication. Patients also participated in a weekly therapy using cognitive-behavioral drug relapse prevention strategies combined with skills training. Outcomes included drinking measured by the time line follow-back method, craving using the Tiffany Craving Questionnaire, psychotic symptoms using the Positive and Negative Symptoms Scale (PANSS), side effects and a measures of abnormal involuntary movements. RESULTS: There were no significant differences in treatment exposure or medication compliance between groups. Naltrexone treated patients had significantly fewer drinking days, heavy drinking days (>5 drinks) and reported less craving compared to the placebo treated patients. Naltrexone did not affect symptoms of schizophrenia, such as psychosis. The medication was well tolerated and there were no group differences in side effects. CONCLUSIONS: These data suggest that naltrexone may be an effective medication for individuals with comorbid alcohol dependence and schizophrenia. Given the widespread problems associated with alcohol misuse in this population, and the lack of effective pharmacotherapies, these findings represent an exciting clinical development.
RCT Entities:
OBJECTIVE:Alcoholabuse in patients with schizophrenia is associated with psychiatric and social complications. While two medications have been approved by the Federal Drug Administration (FDA) for the treatment of alcoholism: disulfiram and naltrexone, no medications have been approved for individuals with alcohol dependence and comorbid schizophrenia. The purpose of this study was to evaluate the efficacy of naltrexone in alcohol-abusing schizophrenicpatients. METHOD: Thirty-one patients with schizophrenia and comorbid alcohol abuse or dependence were treated for 12 weeks in an outpatient study using naltrexone or placebo in a randomized, double-blind fashion in addition to their neuroleptic medication. Patients also participated in a weekly therapy using cognitive-behavioral drug relapse prevention strategies combined with skills training. Outcomes included drinking measured by the time line follow-back method, craving using the Tiffany Craving Questionnaire, psychotic symptoms using the Positive and Negative Symptoms Scale (PANSS), side effects and a measures of abnormal involuntary movements. RESULTS: There were no significant differences in treatment exposure or medication compliance between groups. Naltrexone treated patients had significantly fewer drinking days, heavy drinking days (>5 drinks) and reported less craving compared to the placebo treated patients. Naltrexone did not affect symptoms of schizophrenia, such as psychosis. The medication was well tolerated and there were no group differences in side effects. CONCLUSIONS: These data suggest that naltrexone may be an effective medication for individuals with comorbid alcohol dependence and schizophrenia. Given the widespread problems associated with alcohol misuse in this population, and the lack of effective pharmacotherapies, these findings represent an exciting clinical development.
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