Status:
COMPLETED
Ondansetron With Olanzapine for the Treatment of Alcohol Dependence: A Preliminary Clinical Trial
Lead Sponsor:
University of Virginia
Conditions:
Alcohol Dependence
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study would like to test whether the combination of ondansetron and olanzapine will be superior to placebo at decreasing self-reported heavy drinking among early onset alcoholics.
Detailed Description
Target population: We will enroll male and female who meet DSM IV criteria for alcohol dependence and who are currently drinking equal or more than 21 alcohol units/week for women and equal or more th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00678457
Start Date
January 1 2007
End Date
May 1 2008
Last Update
January 30 2009
Active Locations (2)
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1
UVA CARE
Charlottesville, Virginia, United States, 22911
2
UVA CARE Richmond
Richmond, Virginia, United States, 23294