Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT00678457
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00678457
Study Brief:
Protocol Section:
NCT00678457