Naltrexone Treatment of Alcohol Abuse in Schizophrenia
Condition: Schizophrenia; Mental Disorders; Alcohol Abuse; Alcoholism; Alcohol-related Disorders
MeSH terms: Alcoholism; Alcohol-Related Disorders; Schizophrenia; Mental Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary purpose of this study is to determine whether naltrexone is effective in the
      treatment of alcohol dependence and abuse in patients with schizophrenia and schizoaffective
      disorder. Hypotheses are as follows:

      hypothesis 1: Naltrexone will be more effective than placebo in reducing alcohol use.

      hypothesis 2: Patients responding to naltrexone by reducing alcohol use will also show
      reductions in severity of psychiatric symptoms and utilization of inpatient and emergency
      psychiatric services.

      hypothesis 3: Severity of psychiatric symptoms and amount of service utilization will
      correlate positively with alcohol use.
    

Detailed description: 
      The long-term goal of the proposed project is to improve the treatment of alcohol abuse and
      dependence in patients with schizophrenia and schizoaffective disorder. Alcohol use disorders
      are common among patients with severe mental illness. It is estimated that there may be as
      many as 750,000 individuals in the United States with comorbid schizophrenia and alcohol
      disorders. Alcohol disorder comorbidity requires treatment because it is associated with
      adverse consequences such as increased rates of hospitalization. Yet, to date, there are no
      reports of controlled trials testing the efficacy of pharmacological treatments for alcohol
      abuse or dependence in this population. Naltrexone pharmacotherapy is an effective treatment
      for alcohol dependence, but it has not been systematically applied to the care of patients
      with schizophrenia. The specific aims of this study are: To test the efficacy of naltrexone
      in reducing alcohol use among individuals with schizophrenia and schizoaffective disorder who
      also have alcohol abuse or dependence. We will test hypothesis 1: Naltrexone will be more
      effective than placebo in reducing alcohol use. Our primary outcome measure will be the
      number of drinking days over the course of the treatment trial. To test naltrexone's efficacy
      in reducing psychiatric symptom severity and medical utilization by reducing alcohol use. We
      will test hypothesis 2: Patients responding to naltrexone by reducing alcohol use will also
      show reductions in severity of psychiatric symptoms and utilization of inpatient and
      emergency psychiatric services. To determine the relationship between a) changes in alcohol
      use, and b) psychiatric symptom severity and inpatient and emergency service utilization. We
      will test hypothesis 3: Severity of psychiatric symptoms and amount of service utilization
      will correlate positively with alcohol use. The proposed research will study a cohort of 150
      subjects in a double-blind, randomized, placebo-controlled trial of naltrexone using three
      times per week directly observed administration of medication. The study will be 6 months in
      duration, consisting of a 12-week course of naltrexone or placebo plus 3 monthly follow-up
      interviews after discontinuation of medication. Voucher incentives contingent on attendance
      will be provided to all subjects to ensure attendance for medication administration. Weekly
      motivational enhancement counseling sessions will also be provided to all subjects. Study
      outcomes will consist of self-report and biological measures of alcohol use as well as
      measures of psychiatric symptom severity and medical service utilization.
    

Intervention name(s): Naltrexone or Placebo
Intervention type(s): Drug
Intervention description(s): Naltrexone or Placebo 50 mg per day
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: alcohol; schizophrenia; naltrexone