Status:
COMPLETED
Naltrexone Treatment of Alcohol Abuse in Schizophrenia
Lead Sponsor:
State University of New York - Upstate Medical University
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Schizophrenia
Mental Disorders
Eligibility:
All Genders
18-69 years
Phase:
PHASE4
Brief 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. Hypothes...
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 amo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00145847
Start Date
April 1 2003
End Date
May 1 2008
Last Update
January 8 2013
Active Locations (4)
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1
St. Joseph's Mental Health Services
Syracuse, New York, United States, 13203
2
Hutchings Psychiatric Center
Syracuse, New York, United States, 13210
3
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
4
Veterans Administration Healthcare Center
Syracuse, New York, United States, 13210