Ondansetron With Olanzapine for the Treatment of Alcohol Dependence: A Preliminary Clinical Trial

Inclusion Criteria: * Males and females who have given written informed consent * Aged 18 years and above and weighing ≥40 kg and ≤140 kg * Drinking on average ≥21 and ≥28 drinks/week for women and men, respectively, in the 7-day period prior to enrollment * DSM-IV-R diagnosis of alcohol dependence * Good physical health as determined by a complete physical examination, electrocardiogram (EKG) within normal limits and laboratory screening tests within acceptable range * Negative pregnancy test at intake. * Literate in English and able to read, understand, and complete the rating scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments * Willing to participate in behavioral treatments for alcoholism * Answer an advertisement in the newspaper/radio/television, and express a wish to stop drinking * Provide evidence of stable residence in the last month prior to enrollment in the study, and have no plans to move in the next three months Exclusion Criteria: * Any current axis I DSM-IV psychiatric disorder other than alcohol or nicotine dependence that warrants treatment or would preclude safe participation in the protocol * Severe alcohol withdrawal symptoms that, in the physician's opinion, require inpatient treatment * Serious medical comorbidity requiring medical intervention or close supervision, or any condition that can interfere with the receipt of ondansetron or olanzapine * Severe or life-threatening adverse reactions to the ondansetron or olanzapine medications in the past or during this clinical trial * Female subjects who are pregnant, lactating, or not adhering to an acceptable form of contraception at any time during the study * Received inpatient or outpatient treatment for alcohol dependence within the last 30 days * Significant medical illness (including hypertension) as determined by history and/or complete physical examination. * Gross neurological disease * Mental retardation * Pyrexia of unknown origin * Diagnosis or suspicion of Alzheimer's disease * Clinically significant abnormalities on the EKG that will preclude safe participation * Recent (last 3 months) history of ischemic heart disease or myocardial infarction. * Current infective hepatitis as evidenced by clinical manifestations. If hepatitis is suspected, a hepatitis antibody/antigen screen will be done. * Participation in a clinical study within the last 30 days * Elevation of liver enzymes * History of any severe or life-threatening reaction to olanzapine or ondansetron * Past or current history of seizures disorder * Past or current history of diabetes * Being treated with any medication with potential for clinically significant interactions with alcohol or olanzapine and/or ondansetron. These include:, serotonin antagonists (e.g., ritanserin or buspirone), dopamine antagonists (e.g., haloperidol), or compounds with actions similar to disulfiram (Antabuse®). * Pending imprisonment