Phase
Condition
Tourette's Syndrome
Affective Disorders
Bipolar Disorder
Treatment
N/AClinical Study ID
Ages 18-69 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Males or females, age 18 to 69, with a DSM-IV diagnosis of Schizophrenia,Schizoaffective Disorder, Major Depressive Disorder (MDD) with Psychotic features,Bipolar Type I or Type II Disorder, or Psychosis not Otherwise Specified (NOS)Disorder;
DSM-IV diagnosis of Alcohol Dependence;
Level of Drinking:
At least four days of drinking in the 30 days prior to consent and/or duringscreening period OR
For prospective subjects who are currently in an inpatient or residentialfacility or recently discharged within 30 days prior to consent: At least 4 daysof drinking during the period of time immediately prior to inpatient admissionand/or during post-discharge.
Currently prescribed antipsychotic medications, mood stabilizers, or antidepressants.
One negative urine screen for opiates prior to start of medication and a self-reportof no opioid use for at least 1 week prior to starting medication.
Currently involved in outpatient psychiatric treatment at one of the study sites (Hutchings Psychiatric Center, SUNY Upstate Adult Psychiatric Clinic, St. Joseph'sHospital, VA Medical Center) or at another location in the community.
Exclusion
Exclusion Criteria:
Inability to give adequate informed consent;
Currently taking disulfiram (Antabuse), naltrexone, or acamprosate (Campral);
Current DSM-IV diagnosis of Opioid Dependence;
Current regular use of prescribed opioid analgesics, such as methadone, morphine,codeine, meperidine, and all other opioids. If the subject reports taking a prescribedopioid analgesic only occasionally, the study physician or nurse practitioner willcontact the prescribing physician regarding the safety of study participation and thepossibility of using an alternative. The principal investigator will make the finaldetermination after obtaining the primary physician's recommendation regarding thiscriterion.
Current daily use of non-prescribed opioids.
Currently taking ibuprofen or other potentially hepatotoxic medications in amountand/or frequency judged by the Principal Investigator to pose clinically significantadded risk of hepatic injury;
Female patients of childbearing potential who are sexually active, not sterile, andwho deny using birth control;
Female patients who are pregnant or nursing;
Significant unstable medical problems, including any significant unstable psychiatricdisorders. The study physician conducting the medical history and physical exam willexclude such clinically unstable individuals;
AST (aspartate aminotransferase test) levels: If AST is greater than 3x upper limit ofnormal;
Subjects who do not attend required screening appointments. Subsequent exclusion fromthe study for reasons related to non-attendance will be based on the judgment of theprincipal investigator;
In need of acute medical detoxification from alcohol in the judgment of the studyphysician based on results a score of 12 or more on the Clinical Institute WithdrawalAssessment of Alcohol Scale Based on DSM-III-R (CIWA-AD) and other informationobtained;
Scheduled surgery within 3 months of intake;
Subjects who have pending legal proceedings whose outcome may lead to incarcerationwithin 3 months
Study Design
Study Description
Connect with a study center
SUNY Upstate Medical University
Syracuse, New York 13210
United StatesSite Not Available

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