Naltrexone Treatment of Alcohol Abuse in Schizophrenia

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: State University of New York - Upstate Medical University
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Ethanol; Naltrexone

Criteria

Inclusion Criteria:

1. Males or females, age 18 to 69, with a DSM-IV diagnosis of Schizophrenia or Schizoaffective Disorder;

2. DSM-IV diagnosis of Alcohol Abuse or Alcohol Dependence;

3. Level of Drinking: At least four days of drinking in the 30 days prior to consent;

4. Currently prescribed antipsychotic medication;

5. Currently involved in outpatient psychiatric treatment at one of the study sites (Hutchings Psychiatric Center, St. Joseph's Hospital Health Center, VA Medical Center) or at another location in the community at the time of randomization.

Exclusion Criteria:

1. Inability to give adequate informed consent;

2. Currently taking disulfiram (Antabuse) or naltrexone (ReVia/Depade);

3. Current DSM-IV diagnosis of Opioid Dependence or Opioid Abuse;

4. Currently taking ibuprofen or other potentially hepatotoxic medications in amount and/or frequency judged by the Principal Investigator to pose clinically significant added risk of hepatic injury;

5. Current use of prescribed or non-prescribed opioid analgesics, such as methadone, morphine, codeine, heroin, meperidine, and all other opioids.

6. Female patients of childbearing potential who are sexually active, not sterile, and who deny using a form of birth control;

7. Female patients who are pregnant or nursing;

8. Significant unstable medical problems, including any significant unstable psychiatric disorders. The study physician conducting the medical history and physical exam will exclude such clinically unstable individuals;

9. AST levels greater than 3x upper limit of normal;

10. Subjects who do not attend required screening appointments. Subsequent exclusion from the study for reasons related to non-attendance will be based on the judgment of the principal investigator;

11. In need of acute medical detoxification from alcohol in the judgment of the study physician based on results from the Clinical Institute Withdrawal Assessment of Alcohol Scale Based on DSM-III-R (CIWA-AD) and other information obtained;

12. Scheduled surgery within 3 months of intake;

13. Subjects who have pending legal proceedings whose outcome may lead to incarceration within 3 months of intake.