Naltrexone Treatment of Alcohol Abuse in Schizophrenia
Schizophrenia, Mental Disorders, Alcohol Abuse
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring alcohol, schizophrenia, naltrexone
Eligibility Criteria
Inclusion Criteria: Males or females, age 18 to 69, with a DSM-IV diagnosis of Schizophrenia or Schizoaffective Disorder; DSM-IV diagnosis of Alcohol Abuse or Alcohol Dependence; Level of Drinking: At least four days of drinking in the 30 days prior to consent; Currently prescribed antipsychotic medication; 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: Inability to give adequate informed consent; Currently taking disulfiram (Antabuse) or naltrexone (ReVia/Depade); Current DSM-IV diagnosis of Opioid Dependence or Opioid Abuse; 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; Current use of prescribed or non-prescribed opioid analgesics, such as methadone, morphine, codeine, heroin, meperidine, and all other opioids. Female patients of childbearing potential who are sexually active, not sterile, and who deny using a form of birth control; Female patients who are pregnant or nursing; 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; AST levels greater than 3x upper limit of normal; 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; 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; Scheduled surgery within 3 months of intake; Subjects who have pending legal proceedings whose outcome may lead to incarceration within 3 months of intake.
Sites / Locations
- St. Joseph's Mental Health Services
- Hutchings Psychiatric Center
- SUNY Upstate Medical University
- Veterans Administration Healthcare Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Naltrexone
Lactose pill
Naltrexone 50 mg per day, directly administered as 100 mg on Mondays, 100 mg on Wednesdays and 150 mg on Fridays